SOP 07a: Monitoring of a trial under CESAR responsibility.

Core ‘SOP 07: Data Flow, Monitoring, and Archiving’ was written under the assumption that a trial is sponsored by a pharmaceutical company that also takes the responsibility of monitoring according to Good Clinical Practice (GCP). The SOP 07a is a supplement to SOP 07 and describes the monitoring procedures in more detail. It is applicable if – The supplier of an investigational drug decides to contract the monitoring responsibility to CESAR, or if – CESAR decides to conduct a trial under its sole responsibility, including the sponsor responsibility of ensuring trial monitoring. The Chair of a CESAR working group in close cooperation with the Coordinating Investigator (CI) of a trial has to ensure that appropriately instructed, trained, and experienced persons, e.g. a clinical research associate or a research nurse with particular experience in the conduct of clinical trials according to GCP, are available to perform the monitoring activities defined in this SOP.