The development of E6(R3) will address the complexities of clinical trials in the current global regulatory climate.
The revision will retain the concepts and guidance in E6(R2) as appropriate.
The scope will not be limited to those concepts but will expand, modify,
and reorganize all appropriate sections to provide scientific and ethical guidance that enables a diversity of approaches that are relevant and adaptable to the variety of clinical trial designs and innovative technologies. The revision also aims to address identified gaps or inconsistencies in existing ICH guidance as appropriate
A certificate is issued once a minimum of 80% is achieved in the final test sections of each lesson.
Good Clinical Practice provides a framework of principles that aim to ensure the safety of research participants and the integrity and validity of data. This short course aims to provide the researcher with the basic principles of GCP and how they can be applied practically in the research setting. The course is aimed at all those involved in clinical research.
Upon completion of this course, you will have an understanding of:
* Why GCP is necessary for clinical research professionals
* Historical development of GCP
* The responsibilities of the clinical research professionals
* How GCP should be adopted in the conduct of good clinical research
* How to be a good clinical researcher with MedicReS BeGMR
Arzu Kanik, Prof.Dr. Ph.D., Scientific Director, MedicReS New York * Alvaro Atallah Md, Msc, Internal Medicine & Evidence-Based Medicine, Universidade Federal De São Paulo, Brasil * Brahmajee Nallamothu Md, Associate Professor, Division of Cardiovascular Diseases, Department of Internal Medicine Investigator, Center for the Clinical Management Research University of Michigan * Christiane Druml Ph.D. Vice-Rector for the Clinical Affairs Medical University of Vienna * David Madigan Executive Vice President for Arts and Science and Professor of Statistics at Columbia University in New York City * David Moher Associate Professor, School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa * Delia Wolf Regulatory Affairs & Research Compliance at Harvard School of Public Health, Boston * Denise Esserman Ph.D., Associate Professor of Public Health (Biostatistics), School of Public, Health: Yale Center for Analytical Sciences (Ycas) * Doug Altman Dsc. Director, Centre for Statistics in Medicine, University of Oxford * Fikret İkiz Emeritus Professor, Department of Biostatistics & Bioinformatics, Ege University * Gui- Shuang Ying Md, Ph.D., University of Pennsylvania, School of Medicine, Clinical Trial Coordinating Center, Department of Ophthalmology, Philadelphia, USA * Han Liu Assistant Professor, Department of Operations Research and Financial Engineering Princeton University * Hans Karle Md, Dmsc, Dhc, Frcp, Herlev University Hospital, University of Copenhagen * Iain Hrynaszkiewicz Biomed Central, London, United Kingdom * Iveta Simera Ph.D., Head of Programme Development, Equator Network, Centre for Statistics in Medicine, Oxford UK * Ivonne Solis-Trapala Ph.D., Mrc Fellow in Biostatistics, School of Health and Medicine, Lancaster, United Kingdom * Prof. Jonas Ranstam, Phd, Department of Clinical Sciences, Sweden * Francesca Martinelli, European Organization for Research Treatment of Cancer, Italy * John Overbeke Md, Phd, Representative MedicReS , Past President World Association of Medical Editors, Wame, Netherland * Judith D. Goldberg Professor of Biostatistics at New York University School of Medicine * Liz Wager Phd, Chair of Committee On Publication Ethics (Cope),United Kingdom * Marusic Ana Md, Phd, Chair of The Department of Research in Biomedicine and Health, University of Split School of Medicine, Croatia * Michael Berkowitz Md,Professor of Modern Jewish History ,Dept of Hebrew&Jewish Studies ,Faculty of Arts&Humanities ,London,UK * Michael Festing Phd, Biostatistics ,Cstat, London, UK * Dr. Justine Davies, Executive Editor Lancet, UK * Michael Schemper Phd, Medical University of Vienna, Core Unit of Medical Statistics and informatics, Section of Clinical Biometrics, Vienna, Austria * Monica Gaidhane Md, Mph, Clinical Research Manager at Weill Cornell Medical,Newyork,USA * Shelley Hurwitz Director of Biostatistics in The Center for Clinical investigation at Brigham and Women's Hospital, A Teaching Hospital of Harvard Medical School,Harvard Catalyst, Boston * Shing Lee Phd, Assistant Professor, Biostatistics at The Columbia University Medical Center,New York * Siegfried Kasper Md, Phd, Professor and Chairman, Department of Biological Psychiatry, Medical University of Vienna, Austria * Suzanne Pozsonyi Clinical Research Specialist, Syncon international Clinical Research, Consultancy , Hungary * Trish Groves Deputy Editor,BMJ Publishing Group,Medicine,London * Z. Nazan Alparslan Phd,University of Cukurova, Medical Faculty, Department of Biostatistics .
Use and reproduction of BeGMR e-learning materials: These e-learning materials are owned by MedicReS.
You are free to share or adapt this material, but you must attribute it to MedicReS using the link www.medicres.org.
· Why Good Clinical Research and Good Clinical Researcher
· The Role of Institutional Review Boards/ Independent Ethical Committees
· Informed Consent Documents and Patient Education
· Confidentiality & Privacy
· Participant Safety & Adverse Events
· Quality Assurance
· Developing Research Protocol
· Documentation & Record-Keeping
· Clinical Research Misconduct
· Roles & Responsibilities
· Recruitment & Retention
· The Drug Development Process
Users are required to complete a test following each lesson. To receive a GCP certificate, all tests must be completed with at least 80% accuracy. Upon completing all quizzes, the user will be given access to the MedicReS GCP Certificate of Completion. Within MedicReS certification, there are no expiration dates.
Available for MedicReS Club Members.