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Research in Clinical Trials: Approaches and Methods

Produced on : 10/09/2010
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University of Essex Undertaking a Research Project - (Short Course) This course aims to equip students with the key skills required to undertake a small research project related to their area of practice. The course builds on the foundations laid down in its sister course, 'Developing critical appraisal skills', such as literature searching, reviewing and critiquing, as well as revisiting the research process. The key focus is to expose students to a range of research methods and essential skills in managing a research project. Additional Information The course is studied over 20 weeks on a fortnightly basis although students can undertake part of the programme through work based learning with distance learning support if preferable. The latter part of the course consists of group tutorials. Assessment is by submission of a completed research project Core Research Methods - (Short Course) A 20-25 week advanced training course in research methods for health and social service professionals. It would be beneficial to those interested in research who want to improve their understanding of the research process. This course aims to provide insight into the theoretical concepts underlying the research process with specific emphasis upon health and social research, and to equip students with the ability to carry out health services research. It combines a theoretical with a practical approach to enable students to understand the research literature and the research process and to carry out research in a health service environment. Applying the principles of research to practical service settings is the defining feature of the course. Additional Information Attendance is weekly in term time at the University of Essex, with additional tutorial sessions provided at the students’ request. Successful completion of the course leads to the award of 30 academic credits at Masters level. These credits can contribute to an MSc degree within HHS. Requirements * A relevant first degree or equivalent (e.g. professional experience and responsibility) * Current involvement in a health or social care organisation * Basic IT skills University of Oxford Qualitative Research Methods - Health Sciences Division - (Short Course) The Qualitative Research Methods module explores the ways in which research projects can be designed to explore these issues. The module is structured to help students to design and carry out a qualitative project. Students must identify a work-based issue that can be investigated using a qualitative approach. Students conduct fieldwork to collect data, and practical assistance is given with data analysis and writing up. Small group sessions are used to critically appraise the quality of qualitative research. Funding/fees Qualitative Research Methods £1500 University of Edinburgh Qualitative Methods: Ethnographic Fieldwork - (Short Course) The aim is to approach the main issues in the collection of qualitative data using ethnographic fieldwork through a brief review of conceptual and methodological issues, and a substantial practical component. All the assessment for this course will be through the writing of brief reports on periods of participant observation carried out during the term. At the end of the course, students should: * be able to carry out participant observation * be reflexive about the conduct of qualitative research, and be able to assess critically other pieces of research carried out in this tradition * be aware of the main ethical and theoretical issues raised by this research method Requirements The course is designed for those students who already know they expect to use ethnographic fieldwork, either in their 'home' cultures or 'abroad' for their MSc dissertations or MPhil/PhD research. It is not an introduction to the idea of qualitative research or ethnography, but assumes students already have exposure to some teaching of qualitative research methods in the social sciences. Intending students must attend the first session. Open University Research methods dissertation in social sciences - (Short Course) Researching and writing a dissertation will enable you to consolidate and apply the skills and knowledge gained in earlier postgraduate study. You’ll undertake a substantial piece of independent research on a topic chosen in consultation with your tutor. Depending on your earlier subject choices, you may undertake a small survey, an experiment, an ethnography or a discourse analysis. In some subjects, the research may be literature based rather than empirical. You’ll complete staged assignments throughout the course to help with planning and production, before writing up your research in a dissertation of up to 15,000 words. This course requires extensive preparatory work and early registration is strongly recommended. See Preparatory Work below for further advice on preparing for D845. Requirements You must hold an honours degree, though not necessarily in the subject you wish to pursue. As D845 must be your last course you take, you will need to have already gained 120 points towards your qualification. You will be asked to provide a synopsis of your research topic, so that we can allocate you to an appropriate supervisor. You will not be allowed to progress to the course start if your topic is considered unsuitable for a masters-level dissertation in research methods, or if we are unable to find an appropriate supervisor. Every endeavour will be made to find supervision for students' choice of topics, but we reserve the right to require a change of topic if appropriate supervision cannot be provided. Market Research Society Essentials of Qualitative Research - Briefing, Design, Fieldwork, Analysis to Presentation - The A-Z of Qualitative Research - (Workshop/Seminar) To enable delegates to develop a full understanding of all aspects of the qualitative research process from briefing and research design, through fieldwork and analysis, to presentation of the findings. On completion, delegates should have developed the skills required to: * understand the brief * prepare proposals * understand and apply appropriate research methodologies, including: - sample design and structure - fieldwork considerations - group processes - group moderating - projective techniques * conduct interviews effectively and confidently * analyse and interpret results * present and report findings. Requirements The course will benefit recent entrants to market research with limited practical experience of qualitative research. Funding/fees Members £915 + VAT Non-members £1155 + VAT Date(s) 06/10/2010 to 08/10/2010 University of Oxford Randomised Controlled Trials - Health Sciences Division - (Short Course) This module will take the participants through the process of undertaking a randomized trial. It will focus on the practicalities of organising and running trials rather than the theory, which will have been taught in the introductory modules, and will draw on earlier teaching on, for example, ethics and statistics. It will discuss the practicalities from the perspective of potential principal investigators and, so, will include processes for resourcing the trial, recruiting and randomizing participants, maintaining the trial's momentum, and analysing and reporting it. As well as being relevant to people who will conduct randomized trials, this module has been designed to help people who will use knowledge from randomized trials done by others, since it will provide them with a thorough understanding of decisions that will have been taken during a trial and how this might influence its quality and relevance. Funding/fees £1500 Brookwood International Academy of Healthcare Research Fundamentals of Clinical Research & GCP - (Short Course) This 1-day course is a plain language guide to product development, clinical trial methodology and terminology and essentials of GCP. No prior knowledge or experience is required. This course is ideal for new personnel, those in non-technical roles requiring basic knowledge of clinical trials and GCP responsibilities, administrators, members of non-clinical departments in commercial companies and members of ethics committees. The course is the first day of our Foundation in Clinical Research course. Future dates 16 November 2010 Funding/fees £450 (ex VAT) Date(s) 14/09/2010 Market Research Society Advanced Thinking In Quantitative Research - (Short Course) To raise delegates' awareness of cutting edge techniques and advanced methodologies, and how they can improve business decision making. Requirements This course will benefit senior researchers, marketers and managers who want to understand how the latest thinking in research can make a tangible difference Funding/fees Members £305 + VAT Non-members £455 + VAT Date(s) 29/10/2010 Introduction to Qualitative Research - (Workshop/Seminar) To enable delegates to understand the role and basic methods and skills of qualitative research. On completion, delegates should have an understanding of: * qualitative research, its role in contemporary research and its general application * the process of undertaking a qualitative research project including a breakdown of each stage * how to select an appropriate approach * interviewing and methodological techniques * how to apply interviewing skills * how to process and analyse data. Requirements The course will benefit researchers who are new to qualitative research, and buyers and users of research Funding/Fees Members £305 + VAT Non-members £455 + VAT Date(s) 20/10/2010 Essentials of Quantitative Research - Data Collection, Sampling, Questionnaire Design, Analysis and Presentation - The A-Z of Quant - (Workshop/Seminar) Objective This course enables you to: develop a full understanding of all aspects of the quantitative research process. Learning outcomes By the end of the course, delegates should have developed their understanding of: - quantitative research and when to use it - a range of data collection methods - the fundamentals of sampling - best practice in questionnaire design - basic analysis techniques - special quantitative techniques, e.g. rating, ranking, mean scores - the fundamentals of statistical reliability and significance tests - how to explore data and investigate hypotheses - how to draw conclusions and make recommendations - how to present and report findings This course will include the opportunity to work through a case study from brief to presentation. Requirements This course will benefit recent entrants to market research with little or no practical experience of quantitative research (e.g. research trainees). Funding/Fees Members £915 + VAT Non-members £1155 + VAT Date(s) 13/10/2010 to 15/10/2010 Advanced Qualitative Thinking - Beyond the Norm: What's out there? - (Short Course) This course will enable delegates to appreciate the alternative disciplines available and how these can be integrated to deliver coherent insight. During this course, delegates will experience what leading edge thinking is all about and will be able to try out some specific disciplines for themselves. The course will open up a leading edge way of thinking, enabling delegates to take new ideas back to the workplace. Additional Information The course will benefit researchers and research buyers who have a thorough grounding in qualitative research, and who want to be better able to provide insight in new ways, to justify new approaches to clients, or to write more creative research briefs. Requirements The course will benefit researchers and research buyers who have a thorough grounding in qualitative research, and who want to be better able to provide insight in new ways, to justify new approaches to clients, or to write more creative research briefs Funding/Fees •Members £305 + VAT •Non-members £455 + VAT Date(s) 16/11/2010 Introductory Statistics - (Workshop/Seminar) To enable delegates to understand basic methods of statistics and sampling, and how these can be used to inform and refine approaches to market research. On completion, delegates should have an understanding of: * sampling theory * sampling practice * summarising data * sampling distributions * standard errors and confidence intervals * significance testing * determination of sample sizes. Future dates 10 November 2010 Requirements This course will benefit researchers who wish to gain a basic understanding of the principles of statistical and sampling practice. It is also relevant to those who are looking for a refresher course on the use and interpretation of statistics and sampling Funding/Fees Members £305 + VAT Non-members £455 + VAT Date(s) 15/09/2010 City University Research Methodologies for Practice - (Short Course) This module introduces students to the main principles of research in the behavioural and health sciences. It covers key concepts related to scientific method and the various research designs used in the study of human behaviour, health and illness. Additional Information Level 3, 20 credits. Requirements Each of the online modules can be studied separately for continuing professional development (CPD) purposes. Applicants will normally need to show evidence that they are a post-registration healthcare professional. Institute of Clinical Research Introduction to Clinical Trials & Clinical Trials Practice - (Short Course) This course is designed to educate delegates in the role of clinical research in drug development and in clinical trials methodology and instruct them in the principles of Good Clinical Practice. An introduction to: • Drug development • Statistics for CRAs • Protocol design • Clinical trial design and theory workshop • Case report form design • Pre-trial organisation • Ethics committees and informed consent • Introduction to GCP and investigator selection and motivation • Source data verification and clinical trial monitoring • Quality assurance • Phase I studies • Adverse effects and adverse drug reactions • Regulatory affairs Funding/fees Member £1100 Non-member £1320 Member Health Service / Academic £899 Date(s) 27/09/2010 to 29/09/2010 Staffordshire University Faculty of Health Advanced Clinical Practice - (Taught Course)    This course provides the opportunity for advanced scholarship and comprises 50 per cent theoretical learning and 50 per cent practice-based learning. The clinical focus of the course is a direct result of a need to equip students with a higher level of knowledge and skills necessary to meet the changing demands of the healthcare workplace and is relevant for healthcare professionals who are aspiring to the role of advanced practitioner in one of the following clinical pathways: acute care, primary care or mental health. Practice-based learning is assisted by linking the student with a clinical preceptor who guides and facilitates the development of advancing practice skills in the context of the student's specialist area of practice. The full programme incorporates the Postgraduate Certificate and Postgraduate Diploma as qualifications in their own right or as step-off points on the way to achieving the MSc Advanced Clinical Practice. Requirements Applicants will normally: Be a registered healthcare professional Have a minimum of five years experience as a qualified healthcare professional, three years of which is recent experience in the speciality in which they intend to practice as an advanced practitioner Have the written support of their manager who will support the student to achieve protected time for clinical and classroom-based learning Provide written confirmation of an identified clinical preceptor and senior Funding/fees http://www.staffs.ac.uk/study_here/fees_and_funding/index.jsp Market Research Society Market Research - An Introduction - (Short Course) On completion of the course registrants should have an understanding of: 1 The basics of market research * Research objectives * Research design * Content * An introduction to research methodologies 2 Designing a research project: the tools of market research * Introduction to qualitative research * Introduction to quantitative research * Introduction to sampling and interviewing * An introduction to questionnaire design 3 Completing a research project * Turning data into findings * Reporting and communicating findings * Professional development and the market research industry. Requirements The course will provide a basic introduction and may be particularly suited to support staff, those commissioning research for the first time, those wishing to carry out small-scale research to support their businesses, field workers and those seeking an understanding of the market research industry. Funding/fees Prics £175 + VAT Effective Depth Interviewing - (Workshop/Seminar) To provide delegates with a thorough grounding in the skills necessary for effective depth interviewing in a wide range of qualitative research situations. On completion delegates should: * understand when depth interviews will be effective and be aware of their advantages and drawbacks * show awareness of the processes involved in interviewing and how they affect the interview * use a range of eliciting skills, adapted to match with their own style * identify their barriers to listening * plan an interview and write a topic guide * understand the value of stimulus material * deal with a range of respondents. Requirements This course will benefit researchers who would like to increase their confidence and knowledge of basic interviewing skills, clients who commission qualitative research will also find this 'insiders' view invaluable for buying and managing depth interviewing projects. Funding/Fees Members £305 + VAT Non-members £455 + VAT Date(s) 02/12/2010 ROSTRUM Effective Project Management for Clinical Trials Professionals - (Short Course) Understand and apply the principles of good project management practice so that you can define, plan and manage a clinical trial and other work projects. This course provides you with the knowledge of good project management practice. These skills help you to plan and manage any project, clinical trial or otherwise, and to be confident that you are doing the best possible job from a technical project management standpoint. Although these tools are generic, exercises and discussions will show you how to practically apply them to clinical trials. By the end of this course, you will be able to: * Understand PMI and their project management body of knowledge, and how it fits together * Maximise the success of your project * Plan and manage scope, quality, resources, timelines, budget, risk and stakeholders * Ensure that your project will be run efficiently and effectively * Explain and demonstrate how to apply project management techniques to clinical trials Funding/fees £1,590.00 Date(s) 18/10/2010 to 20/10/2010 Medical Statistics for Non-Statisticians - (Short Course) If you have no formal training or qualifications in medical statistics, but need a basic understanding as part of your role, then this course is ideal for you. Statistics are an important part of the clinical trial process. This course provides a good understanding of the terminology and the methods employed to ensure that clinical trials are designed and analysed appropriately. By the end of the course, you will be able to: * Understand the basic principles of medical statistics * Understand the importance of statistics in clinical trials * Have a greater understanding of the statistical principles in the design of clinical trials * Describe study endpoints and how data are described and presented * Understand the different elements involved in significance testing and interpret the results of statistical analyses. Future dates 1st December 2010 - The Regency Hotel Funding/Fees The full fee for this course is £590 + vat and includes full course materials, lunch and refreshments. Date(s) 27/09/2010 Successfully Managing International Clinical Trials - (Short Course) The trend to perform time efficient clinical development programmes leads to the need for large studies to be run across international boundaries and also the development of global clinical development strategy. This 2-day course is designed for people who already have experience of coordinating and running multicentre clinical trials who wish to gain an understanding of how to run international studies. It is also useful to people who have a little experience in running international studies but who wish to extend their expertise. The course consists of a mixture of interactive presentations and workshops and will encourage delegates to participate fully. This course will also be of interest to anyone involved in designing or critiquing a global clinical development plan or global protocol. Funding/Fees £1,095 +vat If you book on the course more than 9 weeks in advance, a 10% discount will be applied. Date(s) 17/11/2010 to 18/11/2010 Medical Devices Trials - (Short Course) This one-day course is ideal to provide evidence of regulatory inspectors that sponsor, CRO and investigator site personnel have been appropriately trained in the ISO 14155 requirements for conduting clinical investigations of medical devices. This course will introduce, explain and discuss fundamental concepts and current issues relating to compliance, human subject protection, research development and clinical investigation in the current regulatory environment for medical device clinical trials. Knowledge of ISO 14155 is essential to everyone working on medical device clinical trials and for those who work with clinical trial professionals. Regulatory inspectors now look for evidence that professionals working on clinical trials have received regular training in ISO 14155 and also understand how to company with ISO 14155 requirements. By The End Of This Course, You Will Be: - familiar with the most important areas of ISO 14155 - understand the most important principles of ISO 14155 - ensure that informed consent procedures are properly implemented for device trials - understand the requirements for Ethics Committees and Institutional Review Boards and how to obtain approvals - understand the responsibilities of the Sponsor and Investigators - able to ensure successful preparation for ISO 14155 inspection and audit Funding/Fees £599.00 Date(s) 22/11/2010 Diabetes Clinical Trials - (Short Course) Understand current thinking in the area of diabetes, treatment options and the relevance to clinical trial design and conduct. This 1-day course provides participants with an excellent overview of diabetes and alongside the comprehensive medical explanations of the disease and its treatment options, information is also provided on the demographics and economics of diabetes. This link helps organisations to understand their challenges and the importance for their research pipelines, making this a very valuable course for all clinical trials professionals. By the end of this course, you will be able to: * understand the importance and impact of diabetes as a disease area * know the metabolic conditions underlying diabetes * learn about the progress of anti-diabetic therapy * understand current treatment paradigms * strategically assess the future and your organisation’s competitive position Funding/Fees £599.00 Date(s) 02/11/2010 Market Research Society Introduction to Quantitative Research - (Workshop/Seminar) To enable delegates to understand the role and basic methods and skills of quantitative research. On completion delegates should have an understanding of: * basic quantitative research techniques * problem definition, including the client perspective * desk and primary research * sampling and fieldwork issues * limitations of the research process * briefs and proposals * selecting and matching quantitative techniques to the problem defined by the client * questionnaire design issues. Requirements This course will benefit researchers who are new to quantitative research, and buyers and users of research. Funding/fees Members £305 + VAT Non-members £455 + VAT Date(s) 21/10/2010 London School of Hygiene and Tropical Medicine Masters Degrees by Distance Learning Clinical Trials - (Taught Course)    The need for rigorous evaluation of components of health care is increasingly recognised worldwide. An important type of evaluation is the randomised controlled clinical trial. This course is suitable for both those wishing to gain an overall understanding of trials before moving into the field, and those who have general or specialist experience in clinical trials and aim to broaden their role in the design, management, analysis and reporting of clinical trials. Objectives This course aims: to provide students with a theoretical and practical understanding of the issues involved in the design, conduct, analysis and interpretation of randomised controlled trials of health interventions. It will be suitable for students working in high, middle and low income countries. The core study units are common to the Diploma and MSc courses. Students may then tailor the MSc to fit their needs by choosing from a range of advanced modules which will allow them to expand and deepen their conceptual and practical skills. The main disciplinary perspectives will come from clinical trials, statistics and epidemiology, but others will contribute in both the core and optional units. Students will be trained to develop skills to scrutinize information, to critically analyse and carry out research and to communicate effectively. Requirements MSc: A first or second class honours degree or equivalent, from a university or other institution acceptable to the University of London, in a subject appropriate to the course or in another discipline which has, in the opinion of the University, included a suitable preliminary training. An appropriate professional or technical qualification, together with at least three years' relevant experience, which satisfies the University as a qualification equivalent to a Second-class degree may also be considered. Postgraduate Diploma: A first degree in a subject appropriate to the course or in another discipline which has included a suitable preliminary training, or previous education and experience without a first degree, which satisfies the University that the applicant has obtained a level of academic proficiency equivalent to a first degree. Computing Requirements As this course is primarily internet-based. The minimum specifications for a computer include a Pentium processor, Windows 2000 operating system, with 256MB RAM memory and a 4GB hard disk space, and a CD-ROM drive; Internet connection: E-mail and Web access. Funding/fees http://www.lshtm.ac.uk/prospectus/howto/tuitionfees2010-11.html Brookwood International Academy of Healthcare Research Foundation Course in Clinical Research (BASIC COURSE) - (Short Course) A 2-day certification course covering the basics of clinical research & GCP. Ideal for the new or inexperienced and essential for those wishing to attain certification. This course incorporates the Fundamentals of Clinical Research & GCP course (Day 1) Faculty of Pharmaceutical Medicine (Royal Colleges of Physicians of the United Kingdom) has awarded 13 CPD credits to this course We use visual, auditory and kinaesthetic learning methods to make the course fun and enjoyable. Objectives and Course Content Participants of courses learn in different ways. Our foundation course has been designed to ensure that all the visual, auditory and kinaesthetic methods of learning are incorporated. We have drastically reduced the use of PowerPoint presentations and included non-threatening activities. These both enhance learning and make the course far more enjoyable for the participants. No prior experience is required but participants will gain most benefit if they have worked in the field of clinical research for at least six months prior to attendance. At the end of the course participants should have a thorough basic knowledge of the clinical trial process, be aware of the need to comply with GCP and be aware of the most important GCP responsibilities. Our last course in Copenhagen attracted a vast number of enthusiastic comments about our new teaching style, including .... "Finally a course where you don't just sit down and listen for hours all the time. Excellent with interactive sessions — it certainly kept my attention". "Thank you very much — I never thought learning GCP could be so interesting" "A fantastic course with extremely competent teachers who know how to explain the topics in an easy to understand way" This course covers and participants will be made aware of: * the process of the development of a new medicinal product through the various phases of clinical research (Phases I to IV and PMS) * the types of study undertaken (human pharmacology, therapeutic exploratory, therapeutic confirmatory, therapeutic use) * plain language explanations of abbreviations, methodology and terminology including study designs (parallel group/crossover), blinding methods, use of placebo * introduction of GCP and its implementation by standard operating procedures. Funding/fees New two-day course, price reduced to £950 (ex VAT) Clinical Research Club: £875 (ex VAT) Date(s) 14/09/2010 to 15/09/2010 Advanced Course in Clinical Research (& Cert CRGCP Part 2) - (Short Course) This 1-day course covers advanced and practical topics not covered in Part 1. It gives participants the chance to develop their project management and problem solving skills. General awareness information is provided about the new European requirements for interventional trials in humans. Participants who have passed the basic course examination and have attended this course are eligible to sit the optional examination for the “Certificate in Clinical Research & GCP”. The course is also open to participants who do not wish to take the examinations or attain certification. Future dates 18 November 2010 ** Requirements This is an advanced course ideal for those who have already attended the Fundamentals course or have experience in the clinical trial process Funding/Fees Next 1-day course, £450 (ex VAT) - Pay online Date(s) 16/09/2010 University College London Practical Statistics for Medical Research - (Short Course) Medical statistics plays an essential role in all stages of a quantitative health care research project from design through to analysis and interpretation. This intensive course covers the essential principles and methods required. Emphasis is on study design, appropriate analysis, and interpretation of results. The underlying concepts of statistical analysis as well as basic and some more advanced analysis techniques are covered. Sessions include lectures and practical work, both computer based and using small workshops for discussion. The course has been running for more than 10 years and has earned an international reputation. Lectures are taught by experienced medical statisticians from high class academic institutions. Funding/fees The early registration fee for the public sector is £600 and the commercial sector fee is £900. This fee is to be paid in full before the course date. Numbers are strictly limited on a first come first served basis. Keele University Practical Introduction to Running Randomised Clinical Trials - (Short Course) This 3 day course will improve your knowledge and skills in the design, practical conduct, management and analysis of randomised clinical trials (RCTs). Combining talks and workshop activities, you will be guided through the principles, methodology and practical implementation of RCTs. Course content - •Day 1 Key principles and critical appraisal of randomised clinical trials •Day 2 Managing randomised clinical trials: Key issues from protocol to implementation •Day 3 Data issues in the implementation and analysis of randomised clinical trials. Requirements • Individuals who are new to clinical trials, those embarking on clinical trial research and those with some experience of designing and running trials. • Individuals from the full range of clinical researchers, including allied healthcare professionals, and non clinical researchers, including trial managers and R&D managers. • Individuals interested in clinical trials in the primary care setting, at the primary / secondary care interface and in secondary care. Funding/fees £375.00 United Hospitals Bristol NHS Foundation Trust Good Practice in Clinical Research - (Short Course) A five day course covering Good Practice in Clinical Research has been designed by experienced researchers from UBHT and the University of Bristol. The course has been structured to take participants through from initial study design, to regulatory approvals, recruitment, conduct of the study, analysis and closure and is a MUST for both new and experienced staff from all disciplines working in clinical research. The course has been approved for 25 CPD points. Funding/fees Delegates from the Trust and the University of Bristol are asked to complete a registration form and submit this with a personal cheque for £100 as deposit to the R&E Department. Cheques are returned at the end of the course provided delegates attend the training for which they have booked. Whilst this course is intended mainly for staff of the Trust or University of Bristol, a limited number of places are available for staff from other organisations at a cost of £450 for the five day course. Such delegates will be required to make their own travel and subsistence arrangements. Phone the R&D office first to check whether external places are available. Date(s) 04/11/2010 to 08/11/2010 British Association of Research Quality Assurance (BARQA) Implementing Good Clinical Laboratory Practice (GCLP) - (Workshop/Seminar) This course is designed to provide comprehensive guidance and practical help for those who are implementing Good Clinical Laboratory Practice in laboratories which undertake the analysis of samples from clinical trials. The course will address the current regulatory framework for laboratory work in support of clinical trials with reference to the ICH Guideline for Good Clinical Practice, the Clinical EU Trials Directive and related regulations and guidance. The course will also draw on the BARQA guidance document on Good Clinical Laboratory Practice (GCLP). The course is structured to encourage delegates to: * discuss and develop ideas * solve specific problems * examine particular aspects of GCP and GCLP Benefits include: * guidance on the interpretation and application of GCLP within the framework of Good Clinical Practice (GCP) * understand how GCLP fits within a clinical (GCP) programme * practical help on how to implement GCLP within a clinical research laboratory * an opportunity to update your knowledge of GCLP with the current interpretation of requirements including guidance on clinical laboratories published by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). Requirements Who should attend: Laboratory Managers, analysts, investigators, trial coordinators, monitors and auditors working in: * pharmaceutical company laboratories * central laboratories * contract research organisations * hospital laboratories * clinics * investigator sites. Funding/fees Association Members £750 inc VAT Non Members £910 inc VAT The Member rate is available, as a concession, to those working in relevant charities and academic institutions, or for the National Health Service. Date(s) 22/03/2011 to 24/03/2011 Royal College of Anaesthetists Research Methodology Workshop - (Workshop/Seminar) The workshop will be useful for anaesthetists of any grade who are already involved in research or those who are about to embark on a research project. Post FRCA Specialist Registrars and Lecturers will find this meeting to be particularly appropriate to their needs since knowledge of research methodology is one of the non-clinical topics which form an important part of Post FRCA training. Even if actual research is not undertaken it is considered essential for trainees to acquire an understanding of research methodology so that they are able to critically appraise research reports in the literature. Teaching sessions will address: developing a research idea; study design; project management; analysis; presentation and interpretation of data; dissemination of results. Group sessions will allow participants to: Provide criticism of a published research paper; design a clinical trial; detect common pitfalls in analysis and interpretation of data. Additional Information This meeting is approved for 5 CPD points. Date(s) 10/11/2010 Informa EU Clinical Trials Directive - (Workshop/Seminar) The practical effects of the Clinical Trial Directive 2001/20/EC regulations are widespread and on-going. What impact is the Directive having on your clinical trials? Are you losing valuable time seeking clarification? This intensive 2-day interactive training course has been designed to help you meet the challenges of the EU Clinical Trials Directive head-on. Practical sessions, step-by-step guidance and group discussions will help you to perform your responsibilities in line with Directive and reach your targets with a timely and compliant strategy. Requirements Who should attend? Clinical Trials Manager' Regulatory Affairs Manager, GMP Inspector, Clinical Development Manager, Clinical Process Manager Medical Advisor, International/Global Regulatory Affairs Manager, Quality Control/Assurance Manager, Clinical Research Manager, Scientific Affairs Manager, GCP manager, QC Associate Drug Safety Manager, Clinical Operations Manager Clinical Project Leader, Pharmacovigilance Statistician, Biostatistician, Data Manager Clinical Pharmacologist, Clinical Pharmacology, Drug Evaluation Manager, Medical Director. Regulatory Affairs Strategies - (Workshop/Seminar) This course has been designed to help you select the best registration strategy depending on the product area and indication. Submissions are delayed because of lack of CMC / non-clinical / clinical data, inaccurate indications being submitted, and inappropriate procedures being used. The financial consequences are potentially devastating. This interactive 2-day course will provide you with practical information on effective drug registration processes; best practices for integrating regulatory requirements from early stages of development; advice on how to develop RA project teams and strategies that work for both you and the regulators. What Will You Learn? * Formulate regulatory strategies that achieve first class regulatory performance and compliance * Speed up drug registration through skilled utilisation of registration procedures * Reconcile R&D, clinical and marketing demands within the regulatory framework * Manage the practical hurdles of submitting MAA/CTD within the deadlines * Negotiate and respond to regulators’ questions successfully * Understand the impact for your RA strategy of your product’s therapeutic area, proposed indications and other technical and development features * Collect and present key information for the submission dossier to achieve a winning strategy * Make the most out of the Centralised, Decentralised and MR procedure and get fast approval from regulators. Date(s) 29/09/2010 to 30/09/2010 University of Central Lancashire Faculty of Health and Social Care Statistics for Clinical Trials - (Taught Course)    The Cert is designed for those who want to obtain training in the practical application of statistical and IT skills to medical/health research. It is based around the statistical package SPSS. The AdvCert and PGCert Statistics for Clinical Trials are designed for researchers who need more advanced training in research methods and statistics. Students gain expertise in the design and analysis of clinical trials, with specific reference to the determination of sample size. Taught modules use lectures (including some live data analysis), in-class discussion and computer practical sessions. Personal study, facilitated by the University's web based learning environment (eLearn), forms an integral part of the course. Students on all three courses are taught and assessed on data analysis and reporting and critical appraisal of research papers; on the AdvCert and PGCert they are also taught and assessed on designing clinical trials, including development of trial protocols. Requirements A graduate in a medical or health-related discipline, or have some experience of working in medical research together with a basic mathematical knowledge (GCSE Mathematics Grade ‘C’ or better). Funding/fees http://www.uclan.ac.uk/study/fees_and_finance/uk_eu_postgraduates.php University of Cambridge Introductory Statistics and Research Methods - (Short Course) A two-day course covering basic concepts in study design and data collection, summary, analysis and interpretation with practical exercises and applications in health care. This course aims to: * Discuss the strengths and weaknesses of various study designs in medical research * Show how best to collect and summarise data * Describe core statistical inference concepts such as confidence intervals and hypothesis tests * Introduce some further standard methods for analysing health research data. By the end of this course, you should be able to: * Better understand and appraise the published medical literature * Understand, knowing when and how to implement basic statistical tests * Select an appropriate study design to answer particular research questions * Select appropriate statistical tests to analyse data arising. Future dates 15th-16th September 2010 Funding/fees Cambridge University staff: £275 NHS staff: £325 Externals: £375 Date(s) 10/09/2010 to 13/09/2010 University of Bristol Rates and Survival Analysis: Poisson and Cox Regression Models - (Short Course) The course aims to provide a grounding in statistical concepts and methods for the analysis of data where individuals are followed over time. By the end of the course, students should: * understand the usual measures of disease occurrence and exposure effect in longitudinal studies; * be able to use Stata to manage and manipulate person-time data derive graphical displays appropriate for survival analysis, and interpret these; * be able to analyse data using Poisson and Cox regression; * understand the links between these approaches; * interpret the results of survival analyses as presented in the published literature. Course outline: definition of rates and relation between risks and rates; manipulating person-time data in Stata using the st commands analysis of rates; using Mantel-Haenszel methods and Poisson regression; splitting follow up time to allow for exposures that change with time introduction to survival analysis log rank tests and Cox proportional hazards regression; graphical displays for survival analysis. Requirements Participants should have a knowledge of regression analyses and their implementation in Stata of at least the level achieved in the 'Introduction to Regression Models' short course. Funding/fees £540 Date(s) 06/06/2011 to 08/06/2011 Systematic Review In Health Care: Meta-Analysis In Context - (Short Course) Course outline: Introduction to Stata/Introduction to Comprehensive Meta-Analysis Why do we need systematic reviews? Basic statistical methods: fixed and random effects models; Identifying relevant studies; Quality and validity of controlled trials. Group work: Assessing the quality of controlled trials; Group work: Critical appraisal of a published systematic review; Publication bias and other reporting biases; Systematic reviews of observational studies; Advanced statistical methods: Explaining heterogeneity and detecting bias. Optional sessions: Systematic reviews and meta-analyses of diagnostic test accuracy studies; Methods for meta-analysis of observational studies; Mixed treatment comparisons - combining direct and indirect comparisons in meta-analysis; Methods for meta-analysis of trials with numerical outcomes. There will be a choice of computer practicals on basic and advanced meta-analysis in Stata or Comprehensive Meta-Analysis software packages. Requirements Who the course is intended for: This course is designed for clinicians, researchers, public health specialists and other health care professionals who want to critically appraise and/or perform systematic reviews and meta-analyses. It is based on the book with the same title (BMJ Books, 2001). Participants should have knowledge of statistical methods to the level of the Introduction to Statistics course. A basic appreciation of research designs (to the level of the Basic Epidemiology course) would be helpful, as would basic knowledge of Stata. Funding/Fees £600 Date(s) 15/06/2011 to 17/06/2011 Design And Analysis Of Randomised Controlled Trials - (Short Course) The aim of the course is to provide an understanding of key issues in the design, analysis and reporting of clinical trials. The course focuses on randomised controlled trials and other experimental designs used in the evaluation of healthcare technologies. Observational epidemiological study designs, including cross-sectional, cohort and case-control studies, are not covered in this course. By the end of the course, students should: * understand when and why randomised controlled trials are necessary; * understand and be able to address the key decisions that have to be made when designing a trial; * understand and be able to apply appropriate statistical methods in the analysis of trial data, including adjustment for covariates, subgroup analyses and multiple outcomes. Topics to be covered include: * the need for clinical trials * planning issues * pragmatic and explanatory trials * hypothesis testing * clinical and statistical significance * sample size * randomisation * cluster trials * intention to treat analysis * alternative trial designs * multiple outcomes * repeated measures * adjustment for covariates * subgroup analysis * CONSORT guidelines on trial reporting * qualitative methods in clinical trials * health economics in the context of clinical trials * ethical issues in trials Teaching will make up a total of thirty hours, consisting of interactive-type lectures, problem-based learning in small groups and analyses of exemplar datasets using Stata. Requirements The course is intended for anyone involved in the design, running, analysis or reporting of a randomised trial in the academic or NHS sector. Students will be expected to have a knowledge of statistical methods up to the level of the Basic Statistics course, and an understanding of research design up to the level of the Basic Epidemiological Methods Course. Basic knowledge of Stata is preferable but not essential. Funding/Fees £900 Date(s) 14/03/2011 to 18/03/2011 Centre for Evidence Based Medicine One Day Workshop on Evidence-Based Practice - (Workshop/Seminar) The workshop is based on the one day workshop run by the Oxford Centre for Evidence-Based Medicine. The Oxford Centre was established by David Sackett and colleagues in 1994 and its current director is Professor Paul Glasziou. It is run at Keele by three local GPs and the course has been accredited by the Midland Faculty of the Royal College of General Practitioners. Requirements The workshop is intended to serve as an introduction to evidence-based medicine. It is aimed at clinicians and other health care professionals who wish to gain knowledge of critical appraisal and experience in the practice of evidence-based health care. Funding/fees The cost of the one-day workshop is £60. This includes the cost of the course workbook (a BMJ publication) and log book (which retail jointly at £35) and refreshments. Cheques should be made payable to “Keele University”. Date(s) 16/09/2010 University of Cambridge Statistics For Medical Journals - (Short Course) What authors of medical research papers need to know to help their chances of getting published in their preferred journal. "Simply stated, editors cannot guarantee that basic statistical concepts have been properly evaluated and presented in the manuscripts that they publish." - Ray JG, Q J Med 2002; 95:769-74 This course aims to enhance 'statistical thinking' among all those involved with medical journals, whether as: 1. Clinical researcher, or 2. Peer reviewer, or 3. Editorial Board member, or 4. Journal reader By the end of the course, participants should be able to: Identify key contents within each section of a paper's usual IMRD format Understand merits and limitations of various study designs Know when, how and why to apply basic statistical methods Implement good practice when reporting study results Avoid common pitfalls detected by statistical referees during peer review Enhance their chances of publishing in their preferred journals Funding/fees Cambridge University staff: £150, NHS staff: £175, Externals: £200 Date(s) 24/09/2010 Coping With Many Variables - (Short Course) Multivariable analysis is a set of statistical tools for assessing the combined effect of a number of variables on an outcome. The teaching will be motivated by examples from the medical literature. There will be opportunities throughout the day to apply what has been taught. This course aims to: * To give an understanding of the application of Multiple Linear Regression * To give an understanding of the application of Multiple Logistic Regression By the end of the course, participants should be able to: * Understand the principles of multivariable analysis * Know when to use multivariable analysis * Interpret the results of a linear/logistic regression analysis * Appreciate the limitations and pitfalls. Requirements Introductory Statistics and Research Methods or equivalent is a pre-requisite for this course. Funding/Fees Cambridge University staff: £150, NHS staff: £175, Externals: £200 Date(s) 23/09/2010 National Training and Research Appraisal Group (NTRAG) Introduction to Evidence-Based Healthcare - (Workshop/Seminar) This workshop (1 session) is most suited to participants who have little or no experience of evidence-based healthcare (EBH) or critical appraisal skills. The basic concepts of EBH are introduced and a range of research methods is overviewed (study designs, statistical terms, interpretation of results). Funding/fees The cost of the training depends on the type and quantity of workshops requested. Randomised Controlled Trials - (Workshop/Seminar) The evidence that can be derived from one particular type of research - the randomised controlled trial (RCT) - is the focus of this workshop (1 session). Using guidelines and checklists, participants appraise one or two RCTs within the context of a relevant decision-making scenario. Special attention is paid to the presentation and interpretation of results, including the concept of Numbers Needed to Treat (NNT). Funding/Fees The cost of the training depends on the type and quantity of workshops requested. Oxford Brookes University Planning and Managing Clinical Trials - (Short Course) This course comprises a single M level module, designed for those whose work involves them in clinical trials or who wish to become involved in such work. It provides training in line with the European directives on Clinical Trials and Good Clinical Practice (GCP). It offers an opportunity for students to gain an understanding the principles of planning and managing clinical trials on human volunteers. Students will be able to explore and apply relevant knowledge and skills to your own working environment. The module uses a blended learning approach which includes a detailed workbook supplemented by electronic learning materials. This Interactive learning is supported by Brookes’ virtual campus facility. Unit description 1. Introduction to the module and literature skills Includes general information about the module; an introduction to Brookes Virtual (contents, quizzes, electronic activities, assessments and discussion board); assessment criteria; literature searching and critical appraisal skills; databases. 2. Legislation and good clinical practice Offers an overview of the European directives and legislation governing clinical trials in the 21st century; international perspectives; principles of the International Committee on Harmonisation (ICH)-GCP. 3. Drug development and trial planning Explores drug development; pre-study requirements for clinical trials; regulatory approvals for clinical trials; Consort statement. 4. Trial responsibilities and protocols Addresses the roles and responsibilities of investigators, sponsors and others; requirements of clinical trials protocols; legislative requirements for investigational medicinal products. 5. Project management in clinical trials Introduces principles of project management; application in clinical trial management, risk assessment. 6. Research ethics and clinical trials Examines the principles of research ethics, historical perspectives and current statutory requirements; ethical issues in clinical trials. 7. Consent and data protection Explores the principles of informed consent; consent processes; data protection legislation and its application. 8. Data management Introduces trial master files and essential documents; data management. 9. Quality assurance and governance Addresses quality control in clinical trials; monitoring and audit; inspections; pharmacovigilance; research governance. 10. Trial closure and pitfalls Examines trial closure, reporting and legal requirements; common pitfalls in clinical trial management. Additional Information Level M 20 CATS points (equivalent to 10 ECTS credits). Requirements Applicants need to meet the module’s minimum criteria in order to demonstrate that they will be able to study at an appropriate level. Applicants offered a place on the module must have reliable access to the Internet and email. Note: Applicants whose home language is not English must demonstrate that their level of English is appropriate for study at postgraduate level with fluent writing skills. English language requirements are: IELTS level 6.5 or above, TOEFL 600/250 or above, WELT (BBC or above), or equivalent. Funding/fees The cost of the module is £1,160 for UK/EU students (£1,210 for international students). Institute of Clinical Research Clinical Trial Administration; an Introduction - (Short Course) This course aims to provide an introductory training for the CTA to help make sense of the background to clinical research and trial management. Additional Information CPD Points: 10 Date(s) 09/11/2010 Effective Clinical Trial Project Management - (Short Course) The aim of this course is to provide delegates with basic project management techniques that can be applied to clinical trials. Course outline • Definition of project management terms • What does a project manager manage? • The life cycle of a project • Defining a project – developing a project objective • Project constraints • Feasibility studies & assessing risk • The major steps in planning a project • Developing a work breakdown structure • Producing estimates • Agreeing responsibilities • Managing the project team • Creating a task network and schedule • Task dependencies • Critical path analysis • Analysis of resource requirements • Analysing the plan for risk • Tracking the project and dealing with variance • Tracking and managing change • Project close-out Requirements The course is designed for delegates new to the role of clinical trial project management. Funding/Fees Member £1200 Non-Member £1440 Member Health Service / Academic £950 Date(s) 26/10/2010 to 28/10/2010 Market Research Society A Guide to Online Qualitative Techniques - (Workshop/Seminar) This course enables participants to understand more fully the whole range of new, emerging and more established online techniques which have been added to the qualitative researchers’ toolkit Requirements This course will benefit more senior researchers, marketers and research buyers who want to understand the latest thinking in online qualitative research and how they can apply the techniques to enhance their business decision making. Funding/fees Members £305 + VAT Non-members £455 + VAT Date(s) 03/11/2010 Imperial College London Clinical Trial Authorisations and MHRA Inspections - Workshop Series - (Workshop/Seminar) This CRGO workshop will cover: What is a clinical trial?; Current regulations governing clinical trials; Clinical Trial Authorisation application process; EudraCT and Public Access database registration; MHRA Inspections process and common findings; Lessons from the Parexel study at Northwick Park Hospital Funding/fees Free of charge to staff at Imperial and their associated NHS Trusts National Institute for Social Care and Health Research Clinical Research Centre (NISCHR CRC) Talking about Randomised Controlled Trials (Modules 1-4) - (Workshop/Seminar) This event is aimed at researchers and health and social care professionals who participate in informed consent for research and want to improve their practice. The training is also relevant for research support staff that have an interest in the informed consent process. The training includes modules that cover communication issues in challenging situations and conveying the complex information related to different trial designs. The training materials use cancer as an example but the communication issues are easily transferable to other clinical settings. The training uses experiential learning, Trained facilitators use video scenarios, workshops and group discussion to provide a framework to improve communication. Modules 5 – 7 will include: screening and chemo prevention RCTs, discussing complex multi – arm RCT’s and discussing RCT’s with parents and teenagers. Funding/fees Free of charge. Date(s) 18/01/2011 University of Bristol Questionnaire Design, Application and Data Interpretation - (Short Course) To provide a theoretical and practical introduction to questionnaire design, application and data interpretation. By the end of the course participants will understand the key aspects of questionnaire design including developing and evaluating a scale using qualitative and quantitative approaches; administering questionnaires and maximising response rates across a range of health care settings; handling questionnaire data; exploring and analysing qualitative and quantitative questionnaire data. Requirements This course is intended for clinicians, researchers, public health specialists and other health care professionals who want to design and/or use questionnaires in a health care setting, or understand the processes involved in questionnaire design, application and interpretation. Funding/fees £540 Date(s) 04/04/2011 to 06/04/2011 Advanced Epidemiological and Statistical Methods - (Short Course) The course aims to provide a grounding in the concepts and analysis of life-course data, measurement error, clustered data, missing data and causal models. By the end of the course students should: *Understand the concepts of additive and multiplicative interactions and cumulative exposures, and use Stata to explore these concepts; *Understand the potential causes of measurement error, how to minimise and monitor these in study design, and how to incorporate information about measurement error into analyses; *Understand how clustered data arise, the impact this may have on usual methods of analysis, and be able to carry out simple appropriate analyses using Stata; *Understand the problems caused by missing data, and be able to carry out exploratory analyses, imputation and sensitivity analyses using Stata; *Use a causal diagram to assess possible causal pathways, and understand models for exploring causality using observational data. Requirements This course is intended for researchers, applied statisticians and epidemiologists who are familiar with basic epidemiology (to at least the level covered by the "Basic Epidemiology" course), and have experience in analysing epidemiological data. Participants should have a knowledge of basic regression models and their implementation in Stata of at least the level achieved in the "Introduction to Regression Models" course Funding/Fees £900 Date(s) 27/06/2011 Institute of Education, University of London Research Synthesis for Policy and Practice - (Short Course) The module aims to develop an understanding of: the history, theory and purpose of systematic reviews; systematic maps and synthesis; involving users of research in the research process; enabling evidence to be relevant for policy and practice; primary research methods, via the synthesis of primary studies. Additional Information Assessment method (for those taking the module as an MSc course): Coursework Credits (for those taking the module as an MSc course): 30 Requirements Direct entry requirements - Second-class degree in health, education or another area of social science or social policy, or other professional qualification e.g. for teaching, police force, health care, social work. Qualifying tests/papers for applicants not meeting direct entry requirements - If you have qualifications other than those specified above you may be eligible but we may ask you to take a qualifying test. University of Bristol Advanced Stata - (Short Course) The aim of the course is to provide a more advanced knowledge of Stata 9 statistical software package. By the end of the course, students should understand how to use Stata efficiently through using a greater range of commands, using looping structures for repetitive code, automatically formatting and saving output for tables and have the confidence to write their own programmes. Requirements Familiarity with Stata is a pre-requisite for this course. Funding/fees £360. Date(s) 05/05/2011 to 06/05/2011 Introduction To Qualitative Research Methods - (Short Course) The course is intended to give an introduction to qualitative research methods, as used in the social sciences and increasingly in health services research. Participants will gain practical experience in study design and the application of the major research methods. By the end of this short course, participants should be able to: appreciate the importance of qualitative research methods in the study of health, illness and health services research; decide when a research topic requires qualitative research methods and select the most appropriate qualitative format to address the research question; begin to develop skills required to conduct interviews, facilitate focus groups and undertake ethnographic research including observation; begin to understand how to analyse qualitative data; start to understand how to employ qualitative methods alongside other methods in health services research. Requirements This course is open to anyone who would like to understand the use of qualitative research methods and begin to learn how to use them. Attendees do not need to have any previous experience or knowledge of qualitative research methods, although experience of, or ideas about, a research project using these methods would make the course more relevant. Funding/Fees £900 Date(s) 21/03/2011 to 25/03/2011 Introduction To Stata - (Short Course) To provide a basic introduction to the statistical software package Stata 10, including its use for data management and data exploration. By the end of the course students should be able to use Stata 10 to: Input data from a variety of sources; Add labels to a dataset to make it self-documenting; Check data for spurious entries; Recode variables and derive new variables from existing ones; Combine two or more datasets; Produce summary statistics, tables and graphs; Find online help about a given topic or command; Keep a record of their work and ensure it is reproducible Future dates 24-25 February 2011 Requirements The course is intended for anyone who wishes or needs to use Stata. No previous knowledge of Stata or of statistics is required, although familiarity with Microsoft Windows will be assumed. Students will gain the familiarity with Stata that is a pre-requisite for several other courses in this programme. Funding/Fees £360 Date(s) 21/10/2010 to 22/10/2010 Management Forum The Effective CRA/Clinical Trial Administrator /Coordinator - (Short Course) Your role as a CRA or Clinical Trial Administrator / Coordinator is vitally important to ensure that clinical trials are carried out on time, to budget and to ensure they comply with GCP and the EU Clinical Trial Directive. This interactive course will provide you with the skills and knowledge to be a successful and effective CRA or member of Clinical Trial Support staff. It covers all the key aspects which CRAs and support staff are likely to be involved in as well as the most important interpersonal skills necessary to be an effective CRA. This will include:- * Planning and preparation for setting up clinical trials * Understanding your responsibilities at both the study site and the sponsor site * How to carry out the crucial study site visits (including site selection, site initiation, ongoing monitoring and study close down) * How to prepare for an audit and/or regulatory inspection including an overview of common audit and regulatory findings * How to detect and manage the suspicion of fraud * Managing the challenges of technological advances in collecting data * How CRA / support staff can manage the challenges of technological advances on collecting data such as EDC will also be discussed. Additional Information A Certificate of Attendance for Professional Development will be given to each participant who completes the course. Funding/fees £1,125 + VAT. The fee includes course documentation as well as mid-session refreshments and lunch. Date(s) 27/01/2011 to 28/01/2011 PharmaSchool Introduction to Clinical Research - (Short Course) This course is suitable for anyone who is new to Clinical Trials, and needs an understanding of the industry, clinical research and clinical trials. The course can be tailored to a variety of audiences including new recruits and adminstrative staff. Basic Outline: Background to the Industry * The Industry Today * New Product Development * Patent Protection * Race for Approval Product Discovery * Target Identification * Target Validation/Prioritisation * Lead Identification * Lead Optimisation Preclinical Development & Chemistry * Preclinical Testing * Chemistry & Manufacturing Considerations Clinical Development/Clinical Research * Stages of Clinical Research * Phase I & Early Stage Clinical Research * Phase II * Phase III * Late Phase * Phase IIIb * Phase IV * Post Marketing Surveillance (PMS) * Generic Products Overview of Process for a Clinical Trial * Protocol * Obtain Relevant Approvals * Design Case Report Form (CRF) * Product Supply * Recruit, Manage & Monitor Subjects/Patients * Data Management * Analyse & Report Data Organisations involved in clinical research * Organisations primarily interested in the outcome of research * Organisations taking part in conducting the clinical research * Organisations providing clinical research services Requirements Information on fees can be found at: http://www.pharmaschool.co.uk/rfq.htm Clinical Trial Designs - (Short Course) Clinical trials vary widely in design. It is important to understand the design of a trial to be able to effectively review protocols, complete ethics committee submissions, write patient information sheets as well as to design clinical trials. This course provides an essential foundation in clinical trial design and the knowledge needed to be able to design, review and summarise protocols. Trial designs * Parallel * Cross-over * Non-comparative * Challenges and limitations * Bias Types of trial * Objectives * Difference/superiority trials * Equivalence * Non-inferiority Endpoints * Definition * Deciding on * Good, Bad and the Ugly Randomisation * Block Size * Stratification & minimization * IVRS Power and sample size * Entry criteria * Patient numbers * Drop out * Patient populations Requirements This course is suitable for anyone who is involved in clinical trials. This includes: * CRAs * CTAs * Study Nurses * Investigators * Data Managers * Project Managers * Clinical Trial Coordinators * Ethics Committee Members Funding/Fees Information on fees can be found by requesting a quote from: http://www.pharmaschool.co.uk/rfq.htm Date(s) 18/11/2010 Monitoring for Non-Commercial Clinical Trials - (Short Course) The requirements of the new EU directives for clinical research mean that there is now a requirement for monitoring of non-commercial clinical trials. This course provides non-commercial monitors with the knowledge and skills to monitor effectively. Background and history of Good Clinical Practice * Declaration of Helsinki * ICH GCP * EU Clinical Trials Directive * EU GCP Directive * UK Statutory Instrument 1301 Role of the monitor * ICH GCP chapter 5.18 * Qualifications for monitors * Purposes of monitoring * Monitor responsibilities Data Review * CRF review * Source Data Verification * Data Query processes Adverse Event reporting * Definitions * Reporting requirements IMP * Storage and handling * Drug accountability Requirements This course is suitable for those involved in clinical research at site and who have responsibilities connected with monitoring. This would include: * Study Site Co-ordinators * Investigators * Sub-investigators * R&D office staff University of Edinburgh Edinburgh Clinical Trial Management Course - (Short Course) This course is conducted in collaboration with the Scottish Collaboration of Trialists (SCoT) and is recognised by the Medical Research Council. This two-day course focuses on management of randomised controlled trials (RCTs). This year’s course will be on Wednesday 17th November and Thursday 18th November. With a blend of lectures and workshops, and plenty of time to talk to fellow delegates, this course is relevant to people currently involved in managing RCTs and those new to this field. It’s a mixture of education, information exchange, an opportunity for networking, with a pleasant dinner thrown in! The course includes five lectures and five workshops. The workshops cover key topics and involve small group working, facilitated discussion and some practical tasks. The course ends with an ‘ask the Faculty’ session at which a number of small groups will tackle specific questions that have arisen during the course that are of common interest (we can’t guarantee to answer all questions, but we’ll aim to have a good try!). The course is usually oversubscribed, so we encourage early registration to avoid disappointment. Date(s) 17/11/2010 to 18/11/2010 Institute of Clinical Research E-learning 1: Introduction to the EU Clinical Trials Directive - (Short Course) The Institute of Clinical Research's e-learning programme breaks up the directive into easy bite size modules in simple English. * The modules highlight the key areas of the directive and the differences between current ICH GCP practice. * There are simple questions to answer as you work through the modules to let you gauge your understanding. * In conclusion, there is a test comprising 20 multiple-choice questions that provides the evidence that you have a thorough knowledge of the directive and its requirements. * At the end of the programme you can print off a progress sheet to add to your training record. Funding/fees £57.50 to purchase access to the e-learning course. University of Oxford Structure of Clinical Trials and Experimental Therapeutics - Health Sciences Division - (Short Course) This course is aimed at qualified doctors, especially specialist registrars in clinical pharmacology or in training for other medical sub-specialities; clinical research fellows in other specialities; pharmacists; nurses; graduates working in the pharmaceutical industry. Funding/fees £1500 PharmaSchool UK Clinical Trials Legislation - the Statutory Instruments (SIs) - (Short Course) This course provides a basic working knowledge of the legislation and guidance governing clinical trials in the UK. Additional Information The course is aimed at those working in clinical trials in the UK, for example Project Managers, CRAs, CTAs, Auditors, Investigators, Research Nurses. Conducting IND Studies in Europe - (Short Course) This course covers the key aspects of IND requirements which are relevant for an IND study in European sites. * Overview of FDA and it’s departments * Overview of Code of Federal Regulations Title 21 - Relevant regulations for Clinical Research - FDA Guidelines relating to Clinical Research * When and how CFR applies in Europe * Key differences between US and EU requirements - FDA forms - FDA Inspections Requirements Those involved in conducting clinical trials in Europe under FDA regulations, for example, Project Managers, CRAs, CTAs, investigators, study nurses. Understanding Medical Device Clinical Trials - (Short Course) Medical Device Clinical Trials are very different to the more recognised form of clinical trials. Medical Device Trials are conducted under a different series of guidelines and directives and have different factors to address when compared to trials using investigative medicinal products (IMP). This course provides an understanding of these differences and details the various aspects of device trials. This course will give delegates: * understanding of relevant regulations * background to the design of device trials * insight into the operational aspects of these trials Requirements This course is suitable for anyone who is involved in clinical trials with medical devices. This includes: CRAs; CTAs; Study Nurses; Investigators; Data Managers; Project Managers; Clinical Trial Coordinators; Ethics Committee Members. University of Leicester An Introduction to Online Research Methods - (Workshop/Seminar) This workshop will introduce participants to a selection of online research methods. The focus will be on online questionnaires and virtual interviews. The workshop will cover theoretical, methodological and ethical issues and will involve a range of hands-on activities. By the end of the session participants will be able to: Describe a range of online research methods; Outline why online research methods are useful for social science, medical and educational research; Discuss some key ethical and methodological issues surrounding the use of online research methods; Identify if, and how, online methods are of value in their own research; Access web-based resources and support materials to further develop their skills and knowledge in online research methods and teaching online research methods; Develop a basic online questionnaire; and Experience a short online interview. Requirements The workshop will be useful for any researchers considering the use of online research methods and those wishing to gain practical hands-on-experience in the use of online research methods. It is particularly targeted at social science, medical and educational researchers with little or no prior knowledge of online research methods including: - Established researchers - Junior researchers - Research assistants - Research supervisors - Postgraduate students - University administrators - Those involved in teaching research methods (i.e. 'training the trainers') Non-academic users. Entry (no or almost no prior knowledge) Funding/fees £10 - For postgraduate students and postdoctoral researchers. £30 - For staff at UK academic institutions, ESRC funded researchers and registered charity organisations. £150 - For all other participants. All fees include course materials, lunch, morning and afternoon tea. They do not include travel and accommodation costs. University of East Anglia Clinical Trials - (Short Course) This course will enable you to act as a source of advice and expertise as a research specialist and to take a lead on research and audit projects, from the development and design to the implementation, in your own profession within multidisciplinary team projects; to advise and monitor research conducted by other health professionals and to disseminate research findings. Cardiff University Introduction to Clinical Research Regulations - (Workshop/Seminar) This workshop will introduce researchers to the national regulations governing clinical research, specifically the Research Governance Framework for Health and Social Care and the Medicines for Human Use (Clinical Trial) Regulations 2004, as well as addressing some of the over-riding principles of good clinical practice. The primary focus will be on explaining the internal and external processes necessary for obtaining approval for projects which involve NHS patients, staff and facilities. By the end of the workshop participants should have an understanding of: • the background to Research Governance in the NHS; • how to get a sponsor; • the Trust R&D Project registration and Review; • getting ethical approval in Wales; and • the Clinical Trials Directive. Requirements The workshop is suitable for all those who manage or undertake research involving NHS patients, staff or facilities or clinical trials of a medicinal product. University of Cambridge Clinical Trials - (Short Course) A one-day course covering basic concepts in the design, ethics, conduct, analysis and publication of randomised controlled trials including practical exercises and examples. This course aims to: * Present an overview of statistical aspects of clinical trials * Discuss randomisation, protocols, blinding and other important issues in clinical trials * Raise awareness of ethical and publication matters associated with trials * Describe how to plan sample sizes for adequate statistical power By the end of this course, you should be able to: * Understand why randomised controlled trials are so important * Realise the need for a clear protocol before commencing a trial * Perform a power calculation in the simplest cases * Better critique other clinical trials in the published medical literature. Funding/fees Cambridge University staff: £150, NHS staff: £175, Externals: £200 Date(s) 20/09/2010 University of Oxford How to do Research on Therapeutic Interventions (including clinical trials) - (Short Course) This module will cover: * Constructing a protocol (step-by-step guide) - presentation of background science - clear description of objectives - entry / exclusion criteria - treatment delivery - dose modification - statistical analyses - ethical issues - adverse event reporting * How to design pharmacokinetic experiments * How to design pharmacodynamic experiments * How to design an observational (e.g. case-control) study Requirements This course is aimed at qualified doctors, especially specialist registrars in clinical pharmacology or in training for other medical sub-specialities; clinical research fellows in other specialities; pharmacists; nurses; graduates working in the pharmaceutical industry. Date(s) 25/07/2011 to 29/07/2011 AAG Medical Writing Introduction to Medical Writing - (Short Course) A one-day course presented by highly experienced medical writers Topics covered include: * General overview of medical writing * Different medical writing environments * How to get started in medical writing * Good writing style Funding/fees EARLY BIRD" registration fee of £250 +VAT or Standard registration fee is £300 +VAT Date(s) 17/09/2010 ROSTRUM How to Write a Protocol for a Clinical Study - (Short Course) This course is intended for people who have to write clinical protocols, whether they be medical writers or other clinical research personnel. The course will provide a detailed breakdown of how to get started when writing a protocol, the advantages and disadvantages of different study designs and what should be included in each section of the main body of the protocol. The course will be informal and interactive and by the end of the day the delegates will have a better understanding of the need to write a ‘good’ protocol. Funding/fees The full fee for this course is £599 + vat and includes full course materials, lunch and refreshments. Date(s) 14/10/2010 Healthcare Education Services Oncology: Phase III Trials This interactive and informative course provides a comprehensive overview of the planning and implementation of phase III and phase IV oncology clinical trials. The course will demonstrate how oncology trials differ in design and conduct from those in other therapy areas. Delegates can learn to design trials to minimise the deficiencies that lead to inappropriate interpretation whilst maximising the competitive advantage. In addition, delegates will benefit from the perspective and experience of the regulatory bodies on EU oncology directives. Case studies, worked examples and discussion sessions are inherent throughout this two-day course, encouraging a lively and positive learning environment. Topics to be covered include: * Introduction to oncology clinical trial design and planning * Informed consent/patient information * The impact of trials on clinical practice * Statistical analysis and reporting * Health economics assessment * Meta-analysis * Quality of life assessment. Additional Information Healthcare's programmes are approved by the Faculty of Pharmaceutical Medicine for CPD accreditation. Details can be supplied on request. Funding/fees The registration fee is £1,975 plus VAT/TAXES. This includes lunch and refreshments throughout the day. Accommodation costs are not included. Date(s) 09/02/2011 to 10/02/2011 National Institute for Social Care and Health Research Clinical Research Centre (NISCHR CRC) Talking about Randomised Controlled Trials Training (Modules 5-7) - (Workshop/Seminar) Professor Lesley Fallowfield and Dr Val Jenkins from Cancer Research UK Psychosocial Oncology Group at Sussex University have produced a training package that deals with communication issues in the adult oncology trial setting (Modules 1-4). This training has been extended to include modules 5 – 7. This is a one day course aimed at medics and health care professionals who have previously completed modules 1 – 4 in this series. Modules 5 – 7 will include: screening and chemo prevention RCTs, discussing complex multi – arm RCT’s and discussing RCT’s with parents and teenagers. Future dates 4th November 2010 - Blancos Hotel, Port Talbot. 2nd December 2010 Churchills Hotel, Cardiff. Funding/fees This course is offered free of charge Date(s) 12/10/2010 Leeds Metropolitan University Understanding & Evaluating the Evidence - (Short Course) The contents of this module include: • The relationship between knowledge, information and data • Methods of obtaining new knowledge, question formulation, hypothesis formulation and testing • Evaluation of published research • Research design • Qualitative research methods, observation, interviews, focus groups, qualitative surveys etc • Behavioural research methods, repertory grid technique, single case design, measurement of attribution, measurement of attitude • Techniques of data collection, design and use of questionnaires, experimental approaches, randomised controlled trials • Analytical studies, testing of hypotheses in case–control and prospective cohort designs. Design of clinical trials and outcome measures • Statistical methods, use of storage and retrieval systems, descriptive statistics, sampling, correlation and regression, non–parametric and parametric analysis • The structure of a research protocol and a systematic review • Ethical considerations in research design and dissemination PharmaSchool GMP for Investigative Medicinal Product (IMP) - (Short Course) This course aims to provide delegates with an understanding of GMP requirements for IMP and practical guidelines for ensuring GMP is followed at site. Additional Information ABPI Accredited. Requirements The course is aimed at anyone involved in the supply and management of IMP for investigational sites. For example, CTAs, CRAs, Project Managers, Pharmacists, Investigators. Funding/fees The price for each course is £250 +VAT. If you are a freelancer, work for charity, academic institution or in the NHS then you qualify for the non-commercial rate of just £125 + VAT. Date(s) 09/11/2010 Essential Documents - (Short Course) Conducting clinical trials requires a vast amount of documentation. Knowing what the required documentation is at each stage of a trial is essential knowledge for anyone working in trials. Many people start their careers in industry by being a Clinical Trial Assistant (CTA). The CTA role requires an extensive knowledge of documentation and this module is ideal as an introduction or equally as a revision method to help progress to the next level which is often a CRA role. This module details the guidelines and regulations governing the documents, explains what they are and why they are needed as well as providing information about where these should be filed. Course Contents: * Introduction * Section 1: Why Do We Have To Have Them? * Section 2: Where Do I Start? * Section 3: Before The Trial 1 - Protocol And Approvals * Section 4: Before the Trial 2 - Subject Documents * Section 5: Before the Trial 3 - IMP Documents * Section 6: Before the Trial 4 - Administration * Section 7: During the Trial * Section 8: After the Trial Requirements The module is designed for anyone involved in Clinical Trials at either the sponsor side, a CRO or at a trial site. The module is ideal for those wishing to enter the industry to help them at interview to demonstrate an understanding of the role of a CTA, CRA or SSC. Advanced Monitoring - (Short Course) The role of the monitor is a very important one and there are a number of difficult issues which monitors may have to face. This course provides the following: more in depth information on the role of the monitor workshop sessions discussing issues basic project and site management theory Requirements The course is most suitable for monitors with at least 6 months experience, either of on-site monitoring or of managing contract on-site monitors. Clinical Trial Project Management - (Short Course) Everyone manages projects of some description and at the same time are also managed by others while working on a project. These projects can range from an entire clinical trial through to a component, or sub-project, of a trial, e.g. the identification and set-up of investigational sites in a specific country. In order to effectively manage the project it is essential to understand how to plan, track, manage and change a project to ensure the ultimate delivery of a quality product. By the end of the course the participants will be able to: * Identify the components of projects * Use planning methods to determine a project plan * Identify the critical path * Track the project, update the project and forecast future tasks * Implement risk, opportunity and change management * Understand quality and set quality targets for projects. MS Project for Clinical Trials - (Short Course) Microsoft Project is a very effective tool for managing clinical trials. A good understanding of the basics of the software will highlight what an essential tool this can become to the Project Manager. The course teaches the basics and then progresses to the application of the software to clinical trial project management. The course is suitable for anyone involved in managing entire clinical trials or components of clinical trials in the area of for example, clinical operations, data management, statistics, or site management. Basic Outline: * Basics of MS Project * Link, dependencies & constraints * Gantt Charts and formatting * Critical Path Analysis * Setting baselines * Tracking progress and forecasting. Informa Clinical Research Project Management - (Short Course) Would you like to find out how you could make a difference and have an impact on the bottom line? -If your answer is YES! . . . then read on and find out how this course can provide you with the additional training you need to perform better in your role. Setting up and running clinical trials is a complex process. More and more people are looking for ways to improve the results of their clinical projects. Successfully implementing project management techniques is imperative within the increasingly cost and time conscious pharmaceutical environment Requirements All clinical research professionals who are or will be involved in clinical research projects will benefit from this course, including: - Clinical Research - Clinical Projects - Clinical Development - R&D Projects Date(s) 08/11/2010 to 10/11/2010 Anglia Ruskin University Scientific Methods in Health Care Research - (Short Course) This module is designed to meet the requirements of professional bodies in the field of biomedical sciences particularly students taking the Clinical Physiology & Technology BSc (Hons) , but can also be undertaken by anyone with an interest in the increasing influence of scientific knowledge in the contemporary world. This module focuses upon the collection and interpretation of evidence in the medical sciences. The module content includes consideration of the philosophical stances underpinning the generation of scientific knowledge and the ways in which our understanding of the natural world has changed over time. An introduction to the use of electronic databases is designed to facilitate the development of systematic search strategies to access relevant research papers from the world-wide literature. Specific research methods covered will include surveys, experimental designs (including quasi-experiments and randomised controlled trials) and clinical audits. The reliability and validity of data collection in both in vitro and in vivo settings will be considered. Additional Information Assessment: Assessment is in two parts. - A computer-based assessment package will test the student?s knowledge of the research process. - The essay requires the selection and critical review of a scientific research paper chosen by the student. University of Birmingham Research Methods for Clinical Trials Course - (Short Course) The Birmingham Clinical Trials Unit organises a biannual course in research methods for clinical trials, which is designed to help researchers apply the most effective practical methods to answer key problems in clinical and other health care. There is a need to train existing and potential clinical researchers in the design, management, analysis and interpretation of randomised clinical trials. The Birmingham Clinical Trials Unit organises a biannual course in research methods for clinical trials, which is designed to help researchers apply the most effective practical methods to answer key problems in clinical and other health care. Additional Information This course has been accredited with 18 CPD points (6 points per day). Certificates will be issued on the final day of the course. Requirements The course is designed to appeal to a broad audience ranging from those who have little experience in clinical trials to those who wish to widen their knowledge of the conduct of such trials. Attendance would be appropriate for: Clinical researchers who are planning or running a clinical trial. Medical staff involved in clinical trials who are interested in expanding their knowledge. Trial administrators/ research nurses/ statisticians/ others who wish to expand their knowledge of clinical trial methodology Funding/fees Researchers from academic and NHS centres will be charged £350 for the 3-day course, which will cover registration, course materials, teas, coffees, lunches and the conference dinner. Date(s) 08/11/2010 to 10/11/2010 Management Forum Advanced Pharmacovigilance - (Short Course) This course has been designed for persons with at least 2 years worth of knowledge in Drug Safety. The course will provide a very comprehensive and yet practical assessment of the main Regulations required to produce a compliant reporting Company. This course would be of maximum benefit to those safety professionals who are working both in the Clinical and Post-Marketing Safety arena. The course covers very diverse activities within the Safety Department and would be advantageous to those who have either multifunction responsibilities or Medical Directors who manage teams in the various disciplines. Key Topics to be covered: * Due Diligence * Training for Drug Safety - Reporting Duties * Audits and Expectations * Compliance and Drug Safety * Independent Data Monitoring Boards * Product Safety Reviews – Purpose and Function * Safety Reporting in Licensing Agreements * Developing Company Core Safety Information – CIOMS III * PSURs * The EU Clinical Trial Directive * Risk/Benefit Determinations * CIOMS V * Crisis Management. Funding/fees £1,640 + VAT Date(s) 22/09/2010 to 24/09/2010 Institute of Cancer Research Institute of Cancer Research Clinical Trials - (Research Course) The Clinical Trials and Statistics Unit (ICR-CTSU) was established in the 1980s at The Institute of Cancer Research (ICR) as part of the Section of Epidemiology. The main objective of the ICR-CTSU is to design, initiate, conduct and analyse national and international randomised clinical trials of cancer treatment which will directly influence routine clinical practice within the National Health Service and worldwide. Funding/fees Please contact the institute. University of Brighton Doing Qualitative Research - (Short Course) This module provides a practical orientation to qualitative research so students experience the research process addressing issues of design, implementation and writing up. Students gain knowledge of a range of methods for data collection and analysis and are able to evaluate the usefulness of these approaches for different research questions. They also gain experience of using one qualitative research method and write this up. Finally they also develop skills in using a qualitative research computer package to analyse data. Additional Information Mode of study: Extensive, Semester one Assessment; A portfolio that includes: a critical evaluation of a range of methods of data collection and analysis for particular research questions, a qualitative research project, and an NVivo based exercise. Requirements Level three social science or equivalent Evidence-based Practice - (Short Course) The aim of this 20-credit module is to develop an understanding of the principles and components of Evidence-based Practice. Specifically the module will: • provide the student with an ability to formulate focused questions from clinical or policy problems. • find the best evidence to answer such questions. • critically appraise research and other evidence for its validity and usefulness. • provide the student with an ability to incorporate the findings into decisions in clinical practice. • provide the student with the ability to evaluate changes in practice Topics to be covered include: • introduction to EBP – background and principles • what is evidence – how good is the evidence • data, data sources, and outcome indicators • asking a research question and searching for the literature • systematic reviews – what they are, developing a systematic review and critical appraisal of an overview paper • guidelines – development and implementation, including critical appraisal of guidelines paper • evidence blocks • case studies Additional Information Mode of study: Intensive over five days. Assessment: 3000-word assignment Requirements Prerequisites: Graduate programme entry requirements apply. Qualitative Research - (Short Course) This module intends to help students increase their knowledge of qualitative research methodologies. The core modules in research methods within the graduate programme, and the university’s C/DRM provide an overview of both quantitative and qualitative approaches, but there remain distinct needs voiced by a number of students who wish to pursue a more in-depth qualitative modular programme. This module is appropriate for students who wish to engage in a thorough examination of the design issues, data collection and analysis techniques, and the philosophical underpinning of qualitative methodology. Additional Information Mode of study: Intensive (one week) in semester 2. Assessment: A 3,000 word assignment. Requirements Prerequisites: Normal entry requirements for the GPHSS. Quantitative Research Methods in the Social Sciences - (Short Course) This module provides students with practical skills in quantitative research. Students gain an understanding of quantitative research design, data collection methods and sampling, and they employ a range of techniques for analysing large scale quantitative data sets, including multivariate methods. Additional Information Mode of study: Extensive during semester 1. Assessment: A portfolio that includes: a research proposal, and a research report where students use multivariate methods to analyse a large quantitative data set and write up their results in the form of a research report. Requirements Prerequisites: Level three social science module, or equivalent. Research Methods and Critical Appraisal - (Short Course) This 20-credit module runs six times per year because of heavy demand. The aim is to provide students with an understanding of different research methods and the confidence to critically appraise research studies and papers by following critical appraisal guidelines. Students develop a research proposal based on a focused question that is applicable to their work practice or interest. The topics covered include: • overview of research methods • assessing methodological rigour • asking a research question • searching the literature • hypothesis testing • using Minitab • qualitative research methods • randomised controlled trials • systematic reviews • survey designs Additional Information Mode of study: Intensive over five full days. Assessment: 3000 word research proposal. Research question to be agreed with module leader. Requirements Prerequisites: Normal GPHSS entry requirements apply. Research Methods for Health Professionals - (Short Course) It is essential that all those engaged in the health professions should be critical consumers of research. For an increasing number of health professionals, it is also necessary to be able to undertake basic scientific research related to their discipline. Such activity is an integral part of study at Master’s level. This module aims both to enable students to increase their critical understanding of published research findings, and to develop specific research skills in the preparation of research proposals, project design, methods of data collection, analysis and presentation. A balance between quantitative and qualitative methodologies is held throughout the module. Relevant ethical issues and sources of information will be discussed, and appropriate methods of data manipulation and analysis will be reviewed and practised. Students will have the opportunity to conduct a small group study, and the module will conclude with students reporting their findings and reflecting on their experience of the research process. Additional Information Mode of study: Intensive Assessment: Multiple Choice Examination Requirements Prerequisites: In general, a first degree in a professional discipline, together with a natural or social science background is assumed. Candidates without such a background are strongly advised to discuss the module with the module co-ordinator before registering. Research Theory and Practice - (Short Course) To critically examine a range of research methodologies and methods in order to give the researching practitioner an increased understanding of the applicability of differing research approaches in health care practice. This module is designed to enable researching practitioners in healthcare practice to further their knowledge and skills in the practice of research. The module provides access to a flexible learning mode meeting the needs of a changing student population. A range of different research methodologies and methods will be examined. Students will be given the opportunity to simulate and practise different approaches to research by analysing and critiquing scenarios relating to their own practice areas. Additional Information Mode of study: Extensive on line. Requirements Prerequisites: Normal entry requirements for the Graduate Programme and ability to study at masters level. Strategy and Planning in the Public and Voluntary Sectors - (Short Course) This module examines the relevance and application of strategy and planning theory to the modern public service environment, given the increased use of strategic management and planning exercises in the public sector. The characteristics of government plans as documents are explored and related to difficulties of process, culture and implementation. In addition, the module explores the issues of participation, data collection and analysis, and how these issues relate to strategic choice and implementation. Students have the opportunity to evaluate a current or previous strategy or planning process. The module is taught by a mixture of study days and online learning. Students need access to an online computer to take part in some of the learning sessions. They can use the computer pool at the university, but most part-time students gain access to the online learning centre from either work or home. Additional Information Mode of study: Intensive, plus online learning. Assessment: 3,000 word essay. Requirements Prerequisites: Participants will normally be working within a public services context with appropriate qualifications and/or relevant management and or professional experience. Management Forum Essential Guide to Clinical Trial Regulations - (Short Course) The course is relevant for anyone involved with clinical trials or liaising/supporting Clinical research professionals in pharmaceutical, biotechnology CRO and SMO –companies, or study sites including investigator initiated studies. The workshop will also be of interest to those departments who liaise with clinical trial personnel (such as regulatory affairs, clinical trial supply, quality assurance, document management, legal, regulatory authorities, and all other professionals who want to know more about regulations covering clinical trials). Benefits of Attending: * Decipher the framework of Clinical Trial Regulations in Europe * Discuss the European Commission Assessment of the Clinical Trial Directive Consultative process * What could be changed in a Review of the Directive? * Gain an Overview of the EU Clinical Trial Directive and GCP Directive and some of the key issues * Discuss Clinical Trials Authorisations: Regulatory Approval and Ethical Approval * What are the Implications of Running clinical trials in Children: The Paediatric Plan and Ethical considerations * Understand the Legal Aspects of Clinical Trials * Ensure you Comply with Pharmacovigilance & Adverse Event Reporting * Discuss Clinical Trial Data Management including EDC and e-source * Understand FDA requirements * What you need to know about Regulatory Inspections. Date(s) 06/12/2010 to 07/12/2010 Barts and the London NHS Trust Clinical Research Methods - (Short Course) This informal and interactive course will provide delegates with a comprehensive overview of the issues which govern modern medical research. Although primarily geared to trainees in the acute medical specialties, we welcome delegates from all backgrounds. They have assembled a faculty of clinical researchers with particular experience in solving the problems of clinical research during critical illness or emergency situations. This course satisfies the requirements of the higher specialist training academic module and incorporates accredited training on Research Governance. Funding/fees £350 for external candidates £250 for non-BLT employees of North East Thames School of Anaesthesia and the London Intensive Care Medicine Training Scheme Free to trainees employed by BLT at time of course BUT cheque for £250 must accompany application All other grades employed by BLT must pay fee of £250 St George`s, University of London Developing Effective Practice in a Health or Social Care Setting - (Short Course) This module is compulsory for practitioners completing the BSc in Health Care Practice. It is designed to make clear the links between theory and practice. Students will be required to identify a problem in their own area of practice and suggest change(s) to address the problem. During this process they will be expected to adopt appropriate strategies for studying and investigating their chosen topic and demonstrate the ability to lead and manage a change within the context of practice. The selected change will be based on research and/or other appropriate evidence in their area of practice. It is anticipated that students undertaking this module will be working as accountable practitioners and will be in a position to change their own practice and lead and develop others in response to evidence, which supports the change. The module will be practice-led and the theoretical components will reflect the needs of individual students in their own area of practice. It is strongly recommended that students take this module at the end of their programme of study. Additional Information Assessment • Students will be expected to undertake and write up a 10,000 word project, which requires them to identify a problem in their practice and define it. Students then search for relevant literature on the identified topic/subject area, using appropriate strategies and suggest a change which addresses the problem for implementation and evaluation. Where appropriate, students will be encouraged to demonstrate implementation and evaluation of the change in their area of practice. Number of credits & level of study - 45 credits at Level 6 Requirements Students applying for this module in partial fulfilment of the requirements for the BSc Health Care Practice must have successfully completed 120 credits at Level 5 and 60 credits at Level 6. In some instances applicants will want to access this module on a stand alone basis. This will be negotiated with the CPD Programme Office on application. Familiarity with Research Methods is highly recommended. Lancaster University Adaptive and Bayesian Methods in Clinical Research - (Short Course) Clinical trials in therapeutic areas such as cardiovascular disease, cancer and stroke are major undertakings. Many turn out to be negative and do not lead to the registration of a new drug or the introduction of a new treatment. Consequently, there is growing interest amongst clinical researchers in the use of efficient methods for conducting early phase trials to identify the most promising compounds for further study, and in using interim analyses to allow trials to be stopped as soon as there is sufficient evidence to reach a convincing conclusion. Adaptive designs also allow mid-trial modifications to be made to the design so that the accumulating data guides investigators to the most appropriate form of evaluation. Bayesian methods facilitate the inclusion of prior information drawn from expert opinion and from historical data in the planning and interpretation of clinical trials, which can lead to more efficient drug development. Evaluation of adaptive designs and Bayesian methods using SAS will be demonstrated and used in practicals. Discussion groups will focus on dilemmas involved in implementation. Programme: * Single-stage and two-stage designs * Group sequential designs and their evaluation * Sample size reviews * Adaptive designs * Response adaptive designs * A review of the Bayesian approach * Bayesian methods for phase II and phase III clinical trials * Bayesian versus frequentist approaches. Funding/fees Students - £540 Sponsors/Public Section/Academic - £675 Other - £765 Booking less than 6 weeks before the start of course (anyone): - £900 Members of Mathematics and Statistics at Lancaster University - £0 The course fee includes all supporting documentation, refreshments and lunches. Date(s) 14/02/2011 to 17/02/2011 University of Chester Research in clinical Practice - (Short Course) This module will cover the range of research approaches, designs and methods which are applicable in nursing research. It will continue to develop career-long research appreciation and application to practice. Aims: * To further develop the student's understanding of design and methods in nursing research and facilitate application of theory to practice settings. * To develop the student's repertoire of research skills. Module content will include: * Quantitative and qualitative approaches to research. * Research designs including clinical trials, experimental and quasiexperimental approaches, surveys, ethnographic and phenomenological studies. Data collection and analysis. * Validity, reliability and feasibility, trustworthiness and credibility. * Using research in practice, evidenced practice, audit, quality assurance and clinical governance. Practice development and research. * Ethical issues and procedures in nursing research. Additional Information 15 credits at Level 3. Requirements Employer collaboration: Practice development and research units will provide materials, inputs and opportunities. London School of Hygiene and Tropical Medicine CT103 Clinical trials in practice [9160CT103] - (Short Course) The key steps in implementing a clinical trial are investigated in this module, including clarifying and operationalising the primary and secondary objectives of clinical trials, the implications of design choices for implementation of a trial, trial governance, clearances (including research and ethical clearance), and data collection and recruitment methods. The module will explore quality assurance and control, and investigate data processing and management issues including post-trial monitoring. Funding/fees http://www.londonexternal.ac.uk/prospective_stu dents/postgraduate/lshtm/clin_trials/fees.shtml Imperial College London Introduction to Design and Analysis of Clinical Trials - (Short Course) This course is designed to give an introduction to the main statistical ideas and techniques that are used in the design and analysis of clinical trials. The course lasts two days, running from 10.00 am to 4.00 pm on each day. The first day introduces the main statistical ideas relevant to clinical trial design, and the second day is devoted to statistical analysis and reporting of clinical trials. The course would be suitable for anyone who is working on clinical trials, and for those who would like to gain a better understanding of some of the statistical ideas that are nowadays widely used in this area. Only a very basic knowledge of clinical trials and statistics is assumed. The course consists of a mixture of presentations and practical (computer-based) exercises. Future dates Thur 6th & Fri 7th January 2011 Thur 28th - Fri 29th April 2011. Funding/fees £220.00 For staff & students of Imperial College. £410.00 For anyone who is not a member of Imperial College Date(s) 30/09/2010 to 01/10/2010 ROSTRUM GCP Update - Review of the latest requirements in Europe & the US - (Short Course) This intense one day workshop provides the latest developments in GCP to ensure that you are up-to-date and able to meet the requirements for GCP inspection. To ensure clinical trials meet the requirements of the regulatory authorities it is essential that trials are carried out to the latest GCP regulatory requirements. It is particularly important to keep up to date and be familiar with the recent developments in GCP, and also how these are likely to impact on trials in the future for both pharmaceutical companies and the study sites. Regulatory inspectors expect those involved in clinical trials to be updated with recent developments in GCP - this workshop will be ideal for this. By the end of this course, you will: * be familiar with the most important recent developments which are having an impact on clinical trials. * understand the requirements of the recently issued new CT Directive guidelines and hear feedback from the recent EMEA conference on the problems with the CT Directive. * review changes in Europe and the US GCP requirements having an impact in Europe * understand the key recent GCP developments both in Europe and the US * be prepared for GCP inspection * have had an opportunity to discuss your issues in order to help you develop your strategies for managing these GCP changes. Funding/fees The full fee for this course is £650 +vat and includes full course materials, lunch and refreshments. Date(s) 01/11/2010 Clinical Trial Regulations - (Short Course) This course is an essential guide to ensure you comply with the regulatory requirements for carrying out clinical trials. Of specific interest to those departments who liaise with clinical trial personnel and all other professionals who want to know more about the regulations covering clinical trials. This course will cover all of the most important areas of regulations and guidelines controlling clinical trials. To ensure that clinical trials meet the requirements of the regulatory authorities it is essential that trials are carried out to the latest regulatory requirements. It is particularly important to keep up to date and be familiar with the recent developments in regulations for running clinical trials, and also how these are likely to impact on trials in the future for both pharmaceutical companies and the study sites. Funding/Fees £1,290 University of Ulster Research design and statistics - (Short Course) This module provides the foundation for research in the bioscience. The design of experimental investigations and the use of statistical methodology are discussed. The module requires the completion of computer sessions, class projects, a critical evaluation of published literature, problem-based assessments and a research proposal, the latter incorporating issues relating to research governance and research commercialisation. Additional Information This module has a weighting of 15 credits. Funding/fees The cost of this module is £298.50 for EU Residents. The cost of this module is £762.00 for non EU residents. ROSTRUM Interpretation Of Cardiac Investigations For Industry Clinical Trialists - (Short Course) This two-day course is designed to introduce pharmaceutical researchers in the field of cardiovascular trials to be familiarised with different cardiac investigations which are commonly used in conducting cardiology trials. The course covers patho-physiological background of different cardiovascular diseases and conditions and interpretation of the changes which is relevant for cardiac researchers. Programme includes: * Introduction & Objectives * ECG interpretations in common cardiovascular conditions * Echocardiography, modalities and changes in common cardiac conditions * Exercise ECG implications in cardiovascular diagnosis and assessments * Different cardiac monitors and cardiac event recorders * Cardiac catheterisation with haemodynamic changes and measurements, including coronary angiography * Basis of nuclear scanning and its implications and use in cardiology. Funding/fees £1,095 + vat. If you book on the course more than 9 weeks in advance, a 10% discount will be applied. Date(s) 04/11/2010 PharmaSchool GMP for Phase I clinical trials - (Short Course) This course aims to provide delegates with an understanding of GMP requirements for IMP and practical guidelines for ensuring GMP is followed at a Phase I site. The course is aimed at anyone involved in the supply and management of IMP for investigational sites. For example, CTAs, CRAs, Project Managers, Pharmacists, Investigators. Funding/fees The price for each course is £250 +VAT. If you are a freelancer, work for charity, academic institution or in the NHS then you qualify for the non-commercial rate of just £125 + VAT. University of Leeds Research Methods 1 (Academic Unit of Public Health) - (Short Course) This module provides students with a knowledge of, and ability to appraise basic research methods; epidemiology and statistics required of health professionals working in NHS, local government and voluntary community organisations. The module will also support development of research that they do themselves, or commission from others in the future. Students will be introduced to ethical issues in research and research governance. This aim of this module is to enable students to: * Describe the various types of epidemiological study and their indication for use * Describe and discuss ethical issues in the conduct of research * Identify and appraise the main strengths and weaknesses of epidemiological studies, the sources and implications of potential biases; * Use simple statistical information appropriately in the planning, analysis and interpretation of epidemiological studies * Describe and discuss the place of qualitative research At the end of this module, students should be able to: * Explain the role of research and the strengths and weakness of various research methodologies and study designs * Discuss ethical issues in the conduct of research * Explain how data from epidemiological studies can be used to describe health, assess the causes of disease, and evaluate treatments * Describe and present data * Perform basic statistical tests and techniques * Demonstrate ability to critically appraise epidemiological studies published in peer-reviewed journals Skills outcomes * Conduct critical appraisal of journal article(s) * Write outline of research proposal e.g. for dissertation * Present data in appropriate format, including simple data manipulation if appropriate * Perform simple statistical tests Syllabus * Introduction to research methods and epidemiology including ethical issues * descriptive studies * cohort studies; case control studies * randomised controlled trials * meta-analysis * qualitative methods * description of data * hypothesis testing * confidence intervals * measuring association * modelling relationships * diagnostic tests and screening. Appraisal of studies published in peer reviewed journals and the application of results to a scenario of clinical importance Use of epidemiology including the formation of policy in key areas, e.g. anti-smoking policies; screening programmes. Additional Information 15 credits. Requirements Ability to study at level M (normally has obtained 120 credits at level 3). Drug Safety Research Unit Case Narrative Writing for Reporting Adverse Events - (Short Course) This workshop is aimed primarily at people who are new to narrative writing but it may also be of interest to those who feel they need an update. Outline Outline of data elements required for case narrative writing Style and skill involved Handling follow up information Dealing with difficult cases Incorporating narratives into - clinical trial study reports PSURs regulatory safety summaries including CTD Funding/fees £1,050.00 + VAT or £685.00 + VAT (academic units, public sector organisations, registered charities) Date(s) 10/11/2010 to 11/11/2010 Monitoring Safety in Clinical Trials and Drug Development - (Short Course) Outline Objectives of pharmacovigilance planning and monitoring in drug development programmes Pharmacovigilance in clinical trials - a regulatory perspective Pre-registration pharmacovigilance planning Assessing safety issues in the Common Technical Document Planning for pharmacovigilance in the new ICH programme Implementation of the Clinical Trials Directive and the detailed guidance Eudravigilance and proposed DRA tracking of investigational adverse events under the Clinical Trial Directive CIOMS VI issues Communication for the protection of the trial population Monitoring safety with an investigational agent in co-development Development of labelling from Development Core Safety Information through to CCSI and the SPC SAEs in high mortality conditions Unravelling the unexpected Funding/Fees £1,050.00 + VAT or £685.00 + VAT (academic units, public sector organisations, registered charities) Date(s) 01/02/2011 Informa Regulatory Affairs for Clinical Trials - (Short Course) To ensure clinical trials meet the requirements of the regulatory authorities, it is essential that trials are carried out to the latest regulatory requirements. It is particularly important to keep up to date and be familiar with the recent developments in regulations for running clinical trials, and also how these are likely to impact on trials in the future for both pharmaceutical companies and the study sites. This course will also highlight the most important of these key changes, including: - Gain a comprehensive overview of the regulatory requirements for carrying out clinical trials - Develop effective processes for obtaining Clinical Trials Authorisation: - Regulatory Approval and Ethical Approval - Understand the requirements for running clinical trials in Children - Understand the most important legal aspects of clinical trials - Ensure compliance in regulatory requirements for investigational medicinal product, pharmacovigilance, Clinical Trial Data Management including EDC and e-source - Explore recent developments in clinical trial regulations including FDA requirements - Achieve successful regulatory inspection Requirements The course is relevant for anyone involved with clinical trials or liaising/supporting Clinical research professionals in pharmaceutical, biotechnology CRO and SMO –companies, or study sites including investigator initiated studies. The workshop will also be of interest to those departments who liaise with clinical trial personnel (such as regulatory affairs, clinical trial supply, quality assurance, document management, legal) and all other professionals who want to know more about regulations covering clinical trials. Date(s) 27/09/2010 to 28/09/2010 Brookwood International Academy of Healthcare Research Clinical Research & GCP for Data Management - Certificate in Clinical Research Data Management (Cert CRDM) - (Short Course) The Academy holds a two-day course for data management personnel. A list of those interested is now being compiled and a date/venue will be arranged according to demand. The aim of the first day of this course is to provide a core awareness of clinical research and GCP basics. Day 2 will then specialise on issues of relevance to data management. The course aims to provide a practical insight into the development of a computerised system, having due regard for compliance with PIC/S and FDA guidance. In addition the course will developing problem solving skills. The course will also consider preparation for data management audits. At the end of the workshop the participants will have • a good general awareness of the requirements affecting clinical trials, including GCP • a specialised knowledge of the essentials of validation of computerised systems and evaluation of data management systems in preparation for audit. Requirements This course is designed for personnel working in the data management departments of pharmaceutical companies and contract research organisations. Although no experience is required, participants will derive most benefit if they have an awareness of how data is collected and managed in clinical trials. The focus of the course will be on commercial clinical trials in humans. Funding/fees £950 per place (ex VAT): discounts for group bookings London School of Hygiene and Tropical Medicine Clinical Trials - (Short Course) Clinicians, policy makers and patients are increasingly demanding high quality evidence to help with making decisions about health care. There is a hierarchy of such evidence ranging from anecdote and observational studies up to randomised controlled trials (RCTs). In these trials, the effects of different treatments or other interventions are compared to each other by giving the treatments to patients 'at random', thus providing a 'fair' and unbiased comparison. RCTs provide much of the evidence needed to register new drugs for use, but trials are also used for comparing a wide range of non-drug treatments, such as medical versus surgical managements for cancer. This course will provide an introduction to the area of clinical trials, particularly phase III trials, with more detailed coverage of some of the key issues to be considered in their design, analysis and interpretation. Additional Information The course is relevant to all those with an interest in the rigorous evaluation of interventions in health care, particularly clinicians and others working or intending to work in the health services or related areas such as the pharmaceutical industry. University of Southampton Designing and implementing research - (Short Course) The module will enable you to acquire knowledge, skills and understanding required for the development, planning, conduct and completion of your research. In part 2 of the module you will also examine the clinical practice research environment in the context of promoting and inhibiting factors which influence research design, conduct of research and implementation of research to inform practice. You will learn to critically appraise and integrate a wide range of literature related to your research ideas, to identify and justify appropriate and feasible research questions and objectives, to select and appraise methodologies and methods for data collection and analysis. You will also learn about ethics related to research, strategies for dissemination of evidence and the implementation of your findings in practice. We anticipate that you will also become more skilled in influencing and setting practice development and research agendas. Principal content Part one * An introduction to the importance of research, political aspects of health-related research and research funding, and research cultures * Literature searching and critically appraising research material from the literature in your area of interest * Development of research questions and objectives Research paradigms, philosophies and methodologies * Research designs – e.g. randomised controlled trials, surveys, phenomenology, case study and action research * Research methods used in quantitative and qualitative traditions * Construction of data collection tools used in research * Introduction to the issues of reliability and validity and the naturalistic equivalent of credibility and dependability * Statistics: e.g. describing and summarising data, estimation and confidence intervals, hypotheses and significance testing, determining sample sizes * Qualitative data analysis techniques * Ethical issues relating to the conduct of research and research in clinical practice, including, for example, access considerations, data utilisation, risk assessments and research governance * Student presentation and group analysis of their proposed research study Part two * Models for research in practice – academic, clinical and organisational perspectives * Utilisation of research in practice – assessing factors for implementing research and interfaces between research and practice development strategies * Analysis of implementation models promoting clinical effectiveness and practice development. Additional Information 60 Doctoral level credits Level: 5. Funding/fees £4,761 Date(s) 10/11/2010 to 09/12/2010 University of Oxford Randomised Controlled Trials Course: a guide to design, analysis and interpretation and reporting - (Short Course) This course provides a thorough grounding in the principles and practice of randomised controlled trials (RCTs) for the evaluation of healthcare interventions. It will include talks and practicals to give examples and guidance on the methodology of trials using a problem-based learning approach. Requirements The course is aimed at persons planning or actively involved in trials, or individuals interested in furthering their knowledge of trial methodology. Applications are invited from clinical and non-clinical researchers and other professionals allied to medicine. Institute of Clinical Research Medical Device Trials: An Introduction - (Short Course) This introductory course will lead delegates through the regulatory and clinical aspects of conducting device studies with particular emphasis on the differences between device and drug studies. Course outline • What is a medical device and what regulations govern devices? - The philosophy of device development - Types of devices - How devices are classified - The process for CE marking a device and what this means - An explanation of risk management - The role of the competent authority and the notified body - How device development differs to drug development • Clinical data – What? Why? How? and When? - The clinical evaluation route vs. the clinical investigation route - Pre-market studies and postmarket studies - The international standard for conducting device studies ISO 14155, conducting drug/device studies • Considerations for the design of device studies - Blinding and placebo - Randomisation and statistics, - Prospective vs. retrospective - Registries - Issues for drug/device products • The practicalities of conducting device studies vs. drug studies - Obtaining approvals CA & REC, - Agreements and finance - Product training and accountability - Adverse events and device vigilance, monitoring Requirements Clinical research professionals wishing to learn more about device studies including, new employees within device companies, NHS R & D staff interested in device studies, small device companies and those who have worked in drugs but are new to device studies. Funding/fees Fees Member £425 Non-Member £510 Member Health Service / Academic £335 Date(s) 02/12/2010 Keele University Ethical Issues in Clinical Trials - (Short Course) Randomisation and Consent 11:00 – 12:30 In this session we raise some systematic problems with the possibility of achieving valid consent. The session begins by looking at the evidence regarding subjects’ understanding of the concept of randomisation. 12:30 – 1:15 Lunch Sham Surgery 1:15 - 2:45 This session looks at the issue of placebos in research in the form of sham surgery. In the late 1950s research involving sham heart surgery showed conclusively that a particular, widely used procedure had no effect. The procedure in question was no longer used as a result of the study. Is sham surgery research ever permissible? Funding/fees £95 per course. PharmaSchool Sponsor Responsibilities for Clinical Trials - (Short Course) This course provides a working knowledge of the key responsibilities of Sponsors of clinical trials. The course is aimed at those assuming sponsor responsibility for clinical trials and is particularly useful for those who contract out the bulk of the operational aspects of the trial, or non-commercial organisations new to the role of sponsor. University of York Maximising Participant Recruitment to Randomised Controlled Trials - (Short Course) The aim of the course is to highlight various issues related to participant recruitment for randomised controlled trials and to discuss possible solutions to improving recruitment. Requirements The course should be of interest to researchers, nurses, doctors and allied health professionals who are involved in recruiting participants for randomised trials. Date(s) 08/11/2010 Aston University Research Methods - (Short Course) This module provides the basic knowledge needed to conduct practice-based clinical research. It introduces evidence-based optometry which involves learning how to ask answerable research questions, conduct literature searches on electronic databases and critically evaluate scientific publications. Epidemiology is defined followed by an explanation of how to decide upon which study design is most likely to answer the research question. The advantages and disadvantages of cross-sectional studies, case-control studies, cohort studies and randomized-controlled clinical trials are discussed in terms of their susceptibility to bias and other forms of data distortion. Qualitative research, questionnaire studies, meta-analysis and decision analysis are introduced. Differences between discrete and continuous data are explained in the context of deciding whether to use parametric or non-parametric statistical tests to analyse results. This involves learning about the normal distribution and how to select the correct measures of central tendency (mean, mode and median) and dispersion (standard deviation, coefficient of variation, standard error of the mean, confidence limits, range and interquartile range). The calculation of relative risks and odds ratios, together with their respective confidence limits, as a means of assessing disease risk in epidemiological studies is also explained. Evaluation of diagnostic tests is covered in terms of assessing discriminative ability (sensitivity, specificity, predictive values and likelihood ratios, ROC curves), validity and repeatability (Bland-Altman plots, coefficient of variation, kappa). Five lectures are devoted to hypothesis testing and cover testing normality (Kolmogorov-Smirnov one-sample test), the comparison of two (t-tests, Mann-Whitney U test, Wilcoxon signed-rank test) or more (analysis of variance, Kruskal-Wallis test, Freidman test) groups, correlation (Pearson, Spearman and Kendall correlation coefficients), linear regression (slope, intercept, coefficient of determination) and analysis of frequencies (Chi-square goodness of fit and contingency tests, Yates’ correction, Fisher’s exact test, phi coefficient). Descriptions are provided for performing these epidemiological and statistical calculations using SPSS and Microsoft Excel. Finally, clinical research ethics covers landmark documents, key ethical theories, laws protecting research participants, NHS ethics, University ethics and preparation of a research protocol and consent form for ethical approval. Funding/fees £735 per delegate King's College London Clinical Trials - Roles and Responsibilities of Health Care Professionals - (Short Course) This course will enable research nurses and other health care professionals working in this area to explore the multifaceted role and responsibilities of the practitioner in relation to clinical trials. It will enable participants to develop the knowledge and skills required to ensure that these are conducted safely and effectively whilst maintaining scientific integrity. The course will include research methodology, good clinical practice (GCP and EU Directives), ethical considerations, Research Governance, monitoring/management of adverse effects, and the impact of clinical trials on patients, professionals, and others involved in the clinical trials process. Additional Information 15 Credits Requirements Students undertaking this module should be working in clinical trials and should ideally take the module within 18 months of commencing in post Healthcare Education Services Biomarkers: Their Application in Clinical Trials - (Short Course) Advances in biomarker development are revolutionising the way diseases are studied, diagnosed and treated. In this time of high clinical development costs and declining success rates, the importance of biomarkers is a principal factor in transforming drug discovery, molecular diagnostics and clinical development. Throughout the programme, delegates will have the opportunity to discuss and recognise the potential of biomarkers and how they can help the development and commercialisation process. The course will examine the emerging role of biomarkers in both clinical practice and R&D in a number of therapy areas. Data and statistical issues in biomarker discovery and validation will be explained as will the value of trial design to evaluate biomarkers for use in clinical practice. Additionally, experts will look at the processes involved in the development of biomarkers and the future landscape for this developing area. Examples and discussion sessions are inherent throughout, encouraging a lively and positive learning environment. Topics to be covered include: * Biomarker introduction * Biomarker development and validation * Trial designs to evaluate biomarkers for use in clinical practice * Biomarkers in oncology * Trial designs to evaluate biomarkers for use in clinical practice * Biomarkers in oncology * Cardiovascular biomarkers * Biomarkers in psychiatric disorders * Biomarkers in multiple sclerosis * Metabolic applications of biomarkers. Additional Information Healthcare’s programmes are approved by the Faculty of Pharmaceutical Medicine for CPD accreditation. Funding/fees £1,975 plus VAT/TAXES. This includes lunch and refreshments throughout the day. Accommodation costs are not included. Date(s) 17/05/2011 to 18/05/2011 Queen`s University Belfast Clinical Research/Clinical Trials - (Short Course) The aim of this module is to advance the skills, knowledge and training of clinical research practitioners, and those interested in the field, in relation to critical appraisal of clinical trials, design, management and analysis of clinical trial data. The participant will have an understanding of the issues involved in the care of patient’s in clinical trials and the role of clinical trials in the drug development process. University of Birmingham Clinical Trials - (Short Course) The design, implementation and ethics of trials will be explored. This module involves problem based learning and takes a practical approach to the issues of trial management based on the Birmingham Clinical Unit’s considerable experience in this field. It will look at current issues post- Alder Hey and the recent EU directive on trials. London School of Economics and Political Science Introduction to Medical Statistics, Clinical trials and Epidemiology - (Short Course) This course is aimed at providing students with a knowledge on basic statistics, clinical trails and epidemiology from those with an interest in health policy to aid their understanding of evidence on effective health care interventions. This module will provide an overview of the design and analysis of the common types of study designs used in medical research, and how data is summarised and interpreted. These studies are based on describing a group of individuals; identifying risk factors for or causes of disease or early death; and evaluating interventions for treating or detecting disease, or preventing disease or early death. Practical exercises will be used to reinforce the main learning objectives. Introduction to statistical methods, introduction to hypothesis testing, introduction to medical statistics, experimental study design, introduction to epidemiology, introduction to different types of research studies (cross-sectional surveys, epidemiological studies, clinical trials), clinical trial design (including different types of design) and analysis, cohort studies, case-control studies, applications. Analysing and interpreting different types of research studies including different outcome measures. Overview of study conduct ( in particular for clinical trials). Lancaster University Design of Early Stage Phase Clinical Trials - (Short Course) The importance of exploratory clinical research prior to the launch of a large-scale definitive “phase III” clinical trial is becoming increasingly recognised, both in the pharmaceutical industry and in public sector medical research. Early phase trials include first-in-human studies intended to determine a safe dose or range of doses, studies to identify the most effective dose and trials on which a decision whether or not to launch a phase III study will depend. Advances in the identification of medical biomarkers of therapeutic effect and in statistical techniques based on adaptive designs and Bayesian inference now allow such studies to be designed efficiently, to take account of information from a variety of sources and to combine objectives such as establishing safety and seeking evidence of potential benefit. This course will present some of the new methods that are now available. The presentation will concern statistical concepts but is intended to allow non-statisticians to appreciate what is now available, what information is needed for the designs to be set up and what inferences can be drawn from the study results. Illustrative examples, demonstrations of appropriate software and class discussions about strategy will be included. Although the focus of the course will be on trials of new drugs, the methodology has potential for application in evaluations of other medical interventions such as surgical techniques. This course is presented on behalf of the North West Hub for Trial Methodology Research based at the Universities of Liverpool, Lancaster and Bangor. Requirements Suitable for: Scientists and Statisticians Working in Clinical Research Funding/fees All Participants - £75 DHP Research & Consultancy Good Practice in Clinical Trials - (Workshop/Seminar) Clinical trials are at the forefront of contemporary healthcare research and management and it is increasingly important that throughout the healthcare system there is an understanding of how trials work, their ethical dimensions and what is considered best practice. This one-day, unique and highly interactive workshop will ensure you get to grips with the key issues of trial methodology, ethical considerations and the practicalities of real research in the wider context of evidence-based healthcare. Through a combination of presentations, small group problem-based work and whole group discussions, participants will share their ideas and expertise and debate the core aspects of trials methodology. The key issues explored in the workshop are: * How do clinical trials fit in the wider context of evidence-based healthcare? * How can effective public and patient involvement in the trial process be achieved? * What are the salient ethical issues in the world of the structured trial? * How can consent for participation be genuinely informed? * How are trials reported in the scientific literature and popular media and why is this important? Programme outline * Clinical Research – An example from obstetrics. What are the principle issues in good trial design? * An introduction to ‘classic’ RTC design, the different ‘phases’ of trials and the idea of Good Clinical Practice * Research and the ‘Evidence Base’ – what happens to the results of Clinical Trials? * An example from Intensive Care – how can we build on previous research and integrate best practice into an ethically difficult research environment? * How can what you learnt in the workshop be incorporated into the practicalities of real research projects? Requirements Who should attend? Those involved in R&D, clinical practice, management, patient and community representatives, commissioning and governance who want to have a clearer and practical understanding of the core aspects of clinical trial methodology. Funding/fees Price on application. Patient Reported Outcomes in Clinical Trials and Health Care – A Practical Guide - (Workshop/Seminar) Patient Reported Outcome Measures (PROMs) is a relatively new term to describe the different outcomes obtained directly from the patient. Used increasingly in clinical trials as both primary and secondary endpoints and the NHS e.g. Department of Health’s mandatory requirement for collection and use of information derived from PROMs completed by patients undergoing selected NHS funded elective procedures - PROMs can assess the effectiveness of services, treatments and interventions. However, many health professionals are unfamiliar with PROMs in terms of what they are, what they measure and how they can be used. This one-day course will provide delegates with practical guidance on selecting the appropriate PROM, their use and interpretation. Programme Outline: * What is a PROM and why use them? * A look at the different types of information we can get from a PROM * How is a PROM developed? An overview of the key stages in the development of a PROM * Choosing the right PROM – A review of the selection criteria including practicality, purpose of the study, validity and reliability, feasibility generic versus disease-specific * PROMs and commissioning – Can PROM data support the commissioning process? * End-point and Conceptual Model development * Interpreting and presenting PROM data. Requirements Who should attend? This is an introductory course is suitable for clinical trialists, researchers, healthcare professionals and commissioners who have limited experience of PROMs and want to gain a greater and practical understanding of what they are and how best they can be used in different health care settings. Funding/Fees Price on application. University of York Introduction to the Design & Conduct of Clinical Trials - (Short Course) Aims of the course Participants should: • Gain an understanding of the fundamental considerations in designing and conducting a trial. • Gain an understanding of how a poorly designed trial can result in bias. • Know how to maximise recruitment to trials. • Know how to develop a protocol. • Know how to select and design questionnaires and how to maximise response rates. • Know how to store and manage data. • Know which statistics are appropriate for analysing various data sets. • Be aware of current approaches to Research Governance and ethics committees. Funding/fees Registration fees on or before 1st August 2010 - £650 Registration fees after 1st August 2010 - £680. Date(s) 13/09/2010 to 16/09/2010 London School of Hygiene and Tropical Medicine CT208 Further statistical methods in clinical trials [9160CT208] - (Short Course) This module will build on module 'CT102 Basic statistics for clinical trials' to cover more advanced statistical methods used in clinical trials. Topics covered will include the concept of likelihood, the principles of regression and generalised linear models including logistic, Poisson and Cox regression. The module will also cover adjustment for covariates, analyses of repeated measures and other correlated data, missing data, sub-group analyses and sensitivity analyses. Data analyses will be carried out using Stata. Additional Information Assessment: one two-hour unseen written paper and written assignment(s). Funding/fees http://www.londonexternal.ac.uk/prospective_stu dents/postgraduate/lshtm/clin_trials/fees.shtml CT209 Cluster randomised trials [9160CT209] - (Short Course) Trials in which individuals are randomised in groups (clusters) are being increasingly utilised, especially in the fields of infectious diseases, implementation research, and public health and complex interventions. This module will consider the advantages and disadvantages of the use of cluster trials, with particular emphasis on statistical considerations for their design and analysis, as well as the implications for informed consent and reporting. Please note: except with the special permission of the Course Organiser students must study CT208 or EP304 before taking this module Additional Information Assessment: one two-hour unseen written paper and written assignment(s). Requirements [Except with the special permission of the Course Director, students must study 'CT208 Further statistical methods in clinical trials' or 'EP304 Advanced statistical methods in epidemiology' before studying this module. Module CT202 may also be useful but is not a prerequisite.] Funding/Fees http://www.londonexternal.ac.uk/prospective_stu dents/postgraduate/lshtm/clin_trials/fees.shtml Medical Research Council - MRC Workshop: Routinely collected medical data- Use in clinical trials - (Workshop/Seminar) Medical records are increasingly becoming computerised and are potentially available for use in clinical trials. Over the next ten years there is likely to be a significant expansion in the use of such data in trials, both in the UK and internationally. This also provides the opportunity to conduct new types of low-budget trials that would otherwise not be feasible; both to study the safety and effectiveness of new interventions and to look at comparative effectiveness or comparative safety of commonly used but understudied treatments. Workshop participants will be provided with an overview of the opportunities available to use routinely collected medical data to aid in the design of, feasibility assessment for and conduct of clinical trials. In particular, participants will: * Become aware of opportunities in England, Scotland and Wales to access routinely collected medical data in support of clinical trials, including descriptions of current data sources, procedures for gaining approval to access data and strengths and limitations of existing datasets. They will also become aware of ongoing developments and their timeframe for implementation. * Learn from trialists about their experiences in gaining permission for access and using routine data from primary care, secondary care and mortality registers in ongoing and completed trials. This will include the use of data for study design, pre-screening for potentially eligible patients, baseline history, follow-up of prescriptions and study outcomes during the trial and for long-term follow-up beyond the end of the randomised component of a trial. * Identify unresolved methodological and practical problems when using routine health data in trials. Date(s) 24/09/2010

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