Page 502 - 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
4.2 Epic—A software application that manages electronic medical records hospital-wide.
4.3 Health Information Management (HIM)—The group at Children’s Medical Center (CMC) that acquires, maintains, analyzes, and protects digital and traditional medical information vital to providing quality patient care.
4.4 Investigational Drug Service (IDS)—A pharmacy-provided service specializing in the handling, dispensing, labeling, and distribution of investigational drug products used in clinical trials conducted at CMC.
4.5 SharePoint—A web-based collaborative platform that integrates with Microsoft Office and primarily functions as a document management and storage system.
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.
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