Various committees are involved in conducting a clinical trial. Some or all of these committees may be required for your trials. Generally in investigator initiated studies, the lead coordinating investigator will arrange for the required committees.
Trial Management/Steering Committee
This committee is chaired by the coordinating investigator. The members may be made up of collaborators on a grant, representatives of different states in multi-institution studies and/or experts in relevant fields involved in a study. A statistician should be part of the management committee. The primary responsibilities of this group may include: design the study and study protocol, maintenance of the quality of study conduct, ongoing monitoring of individual toxicities and adverse events and writing study publications. This group would meet regularly to review the recruitment rates, follow up rates and safety aspects of the study.
Endpoint Assessment/Adjudication Committee
Independent Data and Safety Monitoring Committee
According to the FDA:
All clinical trials require safety monitoring, but not all trials require monitoring by a formal committee that may be external to the trial organizers, sponsors, and investigators. As noted earlier, DMCs have generally been established for large, randomized multisite studies that evaluate treatments intended to prolong life or reduce risk of a major adverse health outcome such as a cardiovascular event or recurrence of cancer.
For more information, click here.
See also the toolkit on ISDMCs.