Page 180 - 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
5.4.2.2 HIM will send an email to the external reviewer with instructions on how to acquire their password.
5.4.2.3 The external reviewer’s access to electronic records will be automatically terminated as of the date populated in “Request for Access” form completed in Section 5.3.2.1.
5.4.2.4 If electronic copies of regulatory documents were downloaded on the computer per Section 5.2.3, the RC will need to delete the records off the computer at the end of the monitoring visit.
5.5 Access to Other Research Records Maintained as Hardcopies
5.5.1 Original hardcopy research documents will be maintained in a location corresponding to the responsible team (i.e. clinical research office, chart room, etc.). These include, but are not limited to the following types of documents:
• Regulatory documents required to be maintained as hardcopies by the sponsor
• Original informed consent forms
• Original paper CRFs
• Original patient diaries
• Original patient roadmaps
5.5.2 If an external reviewer needs access to original hardcopy documents for a research study, the SC will work with the appropriate study team members to coordinate an on-site visit. If review of electronic copies of records are acceptable, the CCBD CRO will work to provide secure access to scanned copies of the documents.
5.6 Access to Investigational Pharmacy Records
5.6.1 Drug accountability and pharmacy records for investigational agents will be maintained by IDS Pharmacy.
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
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