The ICH E6 defines the protocol as “a document that describes the objective(s), design, methodology, statistical considerations, and organization of the trial”. In short, the protocol is the clinical trial master plan. This webinar will identify the components of the protocol and emphasize which of these components are especially important for the clinical data manager. The protocol objectives will be examined with respect to the special significance of the primary objective. Next the trial design will be discussed relative to the evaluation of the trial objectives. Other topics will include eligibility criteria, the study calendar, treatment of subjects, assessment of efficacy and safety, correlatives and withdrawal of subjects. Finally, there will be a discussion of the clinical data manager’s role in the development of the protocol.
1. Identify the components of the protocol
2. Describe the significance of the primary objective
3. Understand how the trial design evaluates the study objectives
4. Identify the components of the protocol that are most important for the CDM
5. Describe the role of the CDM in the development of the protocol
Beginners to advanced clinical data managers and CRAs.
Meet the Instructor
Tim Breen has been Director of Clinical Research Informatics at the Hoosier Oncology Group since May, 2010. Prior to the Hoosier Oncology Group, he was a Biostatistics Project Coordinator for the Indiana University Division of Biostatistics where he worked for thirteen years. For the past twelve years, he has been involved in Oncology clinical trials both at the Division of Biostatistics and the Hoosier Oncology Group. He has a Ph.D. degree in Physiology and a M.S. degree in Bioinformatics from Indiana University. Also, he is Co-Chair of the Education Committee of the Society of Clinical Data Management where he earned the Certified Clinical Data Manager designation.