Page 503 - 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
5.1.5 If other parties (i.e. RC or QA) need to review and prep for the visit, the Coordinator should begin preparing the files at least 2 weeks prior to the visit date. If the Coordinator needs assistance in preparing for the visit, the Coordinator can request to meet with the RC, QA and/or or any other individuals familiar with preparation and participation in such visits to discuss responsibilities, expectations, or any other items of concern.
5.1.6 During the prep, review, and exit interview, the Coordinator, RC, and/or QA will take note of findings that indicate new/amended processes that should be put into place to ensure patient safety and confirm regulations are followed. Additional opportunities for staff education should be noted.
5.2 Visitor Sign-in and Screening
5.2.1 Any external reviewer coming on site to review research-related records or clinic spaces will need to sign in as a visitor at the Children’s Health Concierge Desk.
5.2.2 All reviewers will need to sign in at the Concierge Desk in person and go through infectious screening, regardless of their need to enter a clinic space, per Children’s Health Policy IC 3.04. A visitor badge will be provided to the reviewer.
5.2.3 The individual, or designee, assigned to the greet the external reviewer will need to escort and monitor the reviewer during their visit.
5.3 Access to Electronic Regulatory Files
5.3.1 Electronic research regulatory files will be maintained by the clinical research coordinator on the Research Share Drive.
5.3.2 If an external reviewer needs access to electronic regulatory files only for a research study, the Regulatory Coordinator (RC) will coordinate setup and access per Attachment 1, “How to Share SharePoint Files Externally”.
5.3.2.1 Since secure access to electronic regulatory documents will be provided via a SharePoint link, the reviewer will need to view records on their company-approved device, whether remotely or on-site.
5.3.2.2 Once the reviewer has completed review, the RC will stop shared access to the SharePoint folders, per Attachment 2, “How to Stop Sharing SharePoint Folders Externally”.
5.3.3 If an external reviewer will need access to electronic regulatory files in addition to Epic patient records, electronic copies of regulatory files may be downloaded on the Children’s computer to be used when accessing medical records per Section 5.3.2.
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