Page 505 - 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
5.6.2 If an external reviewer needs access to the hardcopy investigational pharmacy records for a research study, the SC will work with the IDS Pharmacy team to coordinate an on-site visit. If review of electronic copies of records are acceptable, the study team will work with IDS pharmacy staff to provide secure access to scanned copies of the documents.
5.7 Access to Clinic Space
5.7.1 For patient safety reasons, external reviewers who need access to clinic space will need to undergo a higher level of screening. Thus, the following information will be collected from the reviewer PRIOR to their on-site visit. Visits should not be scheduled until the below are confirmed and screening documentation has been completed per RA guidance o pages 14-24.
• Month and year of birth
• Last four digit of SSN
• Signed affidavit of background check clearance
• Signed for drug screens
• Signed affidavit regarding immunizations
5.8 Final Review Documents
5.8.1 Upon receipt of the findings, set up a meeting with the Regulatory team and QA, if needed, to address findings and assign responsibility for generating responses by the due date.
5.8.2 While monitoring letters and reports need to be saved as sponsor correspondence in the Regulatory Binder, audit letters and reports, unless generated by a study sponsor, should NOT be saved in the Regulatory Binder.
6.0PROCEDURES: DURING TIME OF PANDEMIC
6.1 For remote monitoring visits, complete steps 5.1 through 5.5 (redacted versions of Source documents can be scanned and sent securely to the approved sponsor representative, or to be shared remotely via Zoom; see Q025 non-HIM remote sharing
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