Page 506 - 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
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
8.0CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
R013
04/01/20
Added modified research education coverage plan; Included reference to RA guidance and COVID command structure and the advisement to complete this process virtually whenever possible
A003
R-Com-202
08/01/2022
Removal of COVID restriction & addition of new sponsor representative practices
R013
Page 8 of 8