Page 181 - CHST Research Administration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: R013
SOP Title: External Review of Research Documents and Medical Records
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 of research documents for more information on the approval and process for sharing non-HIM research documents).
6.2 Use the Decision Tree in the Appendix to determine if you should complete 1) Third Party Request (see instructions included following the decision tree) to submit to Deb Town, and/or 2) HIM request (see instructions on page 2 of the HIM request).
6.3 For onsite monitoring requests, please follow steps 5.1 through 5.8 and 6.2.
6.4 Review and complete the attached Memorandum, Updated Guidance For A Mandatory Onsite Research Sponsor Representative Visit.
7.0 DOCUMENTATION 7.1 References
7.1.1 CMC Policy HI 9.13 External Agency Access to Electronic Medical Records Offsite
7.1.2 CMC Policy IC 3.04 Health Care Personnel (HCP) Health Program
7.1.3 Updated Guidance For A Mandatory Onsite Research Sponsor Representative Visit
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