The Clinical Research Associate (CRA) is the primary representative of the sponsor and arguably has the most direct impact on the proper and accurate reporting of adverse events in clinical trials. This impact is encompassed within the following responsibilities. The CRA is the first line of communication between the sponsor and investigator throughout the study. One of the most critical functions of the CRA is to assure that investigators are fully aware of, and comply with, their responsibilities for adverse event reporting. To achieve this, the CRA must often teach the adverse event reporting requirements to investigators.
This topic describes: Evaluating & Selecting the investigators, Pre Study Visit (site selection visit), Site Initiation Visit, Routine Monitoring Visit, Site Close out Visit, Brief List of Responsibilities and Qualification.