Page 178 - 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
5.0 PROCEDURES: DURING NORMAL CONDITIONS
5.1 Scheduling External Reviewer Visits
5.1.1 When an external reviewer (e.g. sponsor, consortium group, state/federal group, etc.) provides notification of an upcoming monitoring or auditing visit, the visit date needs to be coordinated to include all parties that need to be present during the visit:
5.1.1.1 Principal Investigator (PI)—Email the PI to coordinate time and availability to address any needed documents and to determine availability for the exit interview, as applicable.
5.1.1.2 Investigational Drug Services (IDS) Pharmacy (if applicable)—Coordinate time and availability for a Pharmacy visit (as needed).
5.1.1.3 Research Administration Staff—Due to varied CRO staff schedules, determine when they can be present for the visit or exit interview (as needed).
5.1.1.4 Accreditation/Regulatory Affairs (for state/federal visits)— Immediately notify the relevant individuals (within 1 business day) of receiving notice of a planned visit.
5.1.2 Once the on-site visit date(s) are confirmed, notify the Team Lead to add the scheduled visit to the CRO calendar (i.e. include details of the number of workstations needed, medical records access needs, etc.).
5.1.3 Send notification of the confirmed visit date(s) to all relevant parties. If applicable, notify IDS Pharmacy of the confirmed visit by sending an Outlook appointment to IDSRx@childrens.com.
5.1.4 Coordinate access to research documents, participant medical records, etc. per SOP sections below.
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
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