Page 177 - 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
1.0 PURPOSE
This procedure outlines the process for providing external reviewers (e.g. monitors, auditors, and state/federal reviewers) with access to research documents, participant medical records, and clinic space to observe study-related procedures performed at Children’s Health.
2.0 SCOPE
This procedure is applicable to all research studies done within CCBD that are subject to review by an external third-party 1) during normal conditions, and 2) during time of pandemic and HICS structure.
3.0 RESPONSIBILITY
The Research Administration team is responsible for coordinating access to the appropriate research documents and participant medical records to an external reviewer. They will work with the appropriate departments at Children’s Health so that records can be provided in a manner that is secure, confidential, and per institutional requirements.
4.0 DEFINITIONS
4.1 Clinic Space—An area where patients are seen, examined, treated, have procedures performed, etc. This does not include the pharmacy or conference rooms that are often utilized to host monitors during typical site visits.
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.
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