Page 501 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Com-202
SOP Title: External Review of Research Documents and Medical Records
✓
Review of IP supply and comparison to documentation
✓
Review of informed consent documents for each subject
✓
Review of regulatory study document files (essential documents)
✓
Review of CRFs and comparison to source documentation (e.g., medical record)
✓
Review facilities and equipment
✓
Verification that only eligible subjects are enrolled
✓
Verification of investigator compliance with protocol and any amendments
✓
Verification that any therapy modifications are documented
✓
Verification that investigator and staff are adequately informed about the trial
✓
Verification of complete and accurate reporting of adverse and serious adverse events
✓
Verification that the investigator has accurately prepared and provided all required reports to the sponsor, IRB, and institution, and that each document is complete, accurate, dated, legible, and properly identifies the trial
✓
Verification that any missed visits, tests, or procedures are accurately documented on the subject’s CRF
✓
Notification of the investigator of any CRF discrepancy, entry error, omission, or illegibility
✓
Verification that all subject withdrawals or drop-outs are reported and explained
✓
Verification that the CRF corrections are made with dated, initialled documentation and explained, if required
✓
Verification that only authorized persons have written on the CRF
✓
Verification that essential documents are maintained
✓
Assessment of the financial status of the study and requesting payment in accordance with the study contract
✓
Communication of deviations from procedures, GCP or the protocol to the investigator, and the actions required to secure compliance
✓
Preparation of a report of monitoring findings (Preliminary during the visit and final after the visit)
✓
Training of the investigator and/or staff in areas that require additional training
✓
4.0 DEFINITIONS
4.1 Clinic Space—An area where patients are seen, examined, treated, have procedures performed, etc. This does not include the pharmacy or conference rooms that are often utilized to host monitors during typical site visits.
Page 3 of 8