Description
The sponsor takes responsibility for the trial’s initiation, management, and/or financing. A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a contract research organization, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.
Duties and functions discussed in this module include trial design, selection of investigators, QA and QC, data handling and record keeping, finance and compensation, regulatory submissions, management of investigational product(s), safety reporting, monitoring, audit, dealing with noncompliance, and clinical trial reports.
ICH guideline E6 (revision 2) encourages sponsors to adopt a risk-based approach to managing the quality of trials. We discuss this approach in general, and aspects such as risk-based monitoring in particular.
