Page 504 - 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
5.4 Access to Research Participant Medical Records
5.4.1 Electronic medical records of research participants will be maintained in Epic.
5.4.2 If an external reviewer needs access to electronic medical records for a research participant, an on-site visit will need to be scheduled and a Children’s owned computer will need to be available for accessing Epic.
5.4.2.1 The Study Coordinator (SC) will complete and submit the “Request for Access to Medical Records for Research Purposes” form, at least 2 weeks prior to the visit, per Attachment 3, “How to Request Monitor Access.
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.
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