CRA/ Monitor Roles and Responsibilities
- 2. CRA / Monitor Who is CRA? Acts as main line of communication between sponsor and the investigator. Visit & work with sites on behalf of sponsor Performs variety of clinical operations & monitoring activities Often called as ‘Clinical Monitor’ or ‘Study Monitor’ 2
- 3. CRA’s Responsibilities Recruiting Investigators Pre-Study Visits Site Initiation Visits Routine Monitoring Visits Site Close Out Visits Feasibility of trial Not acceptable Acceptable 3
- 4. CRA’s Responsibilities…cont’d Evaluating the investigators The Monitor is responsible for evaluating the investigator/institution. Each investigator should be qualified by training experience and should have adequate resources to properly conduct the trial for which the investigator is selected 4
- 5. CRA’s Responsibilities…cont’d Pre Study Visit (site selection visit) Conducted at a potential research site Assess the investigator’s experience, staff, facility and potential patient population Introduce the study & obligations to the potential investigator & staff 5
- 6. CRA’s Responsibilities…cont’d Site Initiation Visit Conducted at a confirmed research site Verify the confirmed investigator’s experience, staff, facility and potential patient population Detail the study & obligations to the potential investigator & staff Collect all essential documents before this visit 6
- 7. CRA’s Responsibilities…cont’d Routine Monitoring Visit CRA’s main activity – study monitoring Purpose of monitoring: rights & well being of subjects are protected reported data are accurate, complete & verifiable from source documents trial conduct is in compliance with protocol, GCP & applicable regulatory requirements 7
- 8. CRA’s Responsibilities…cont’d Site Close out Visit Site close out visit is conducted when Study is complete & finished Enrollment has stopped All subjects have completed their study related activities Data are complete & correct Final IP accountability is done 8