Page 344 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Rec-003 SOP Title: Secured Shared Drive
1. PURPOSE
The purpose of this standard operating procedure (SOP) is to outline the requirements for managing essential regulatory documents on the secured shared drive.
2. INTRODUCTION
A Regulatory binder is a compilation of essential documents that are generated throughout the various stages of a clinical trial, including, before the trial begins, during the conduct of the trial, and after completion or termination of the trial. As the industry continues to evolve, a more versatile clinical research program adapts regulatory binders to electronic regulatory binders maintained on a secured shared drive.
Essential documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of Good Clinical Practice (GCP) and with all applicable regulatory requirements.
The outlined documents are routinely monitored and audited by the sponsor and the regulatory authorities as part of the process to confirm the validity of the trial conduct and integrity of the data.
3. SCOPE
This SOP applies to all clinical research staff on the study team that conduct clinical research at Children’s Health System of Texas (CHST). The study team as defined in Children’s Health Clinical Practice Policy 7.12, Responsibilities of the Research Team will ensure adherence to this SOP. In some case, a UTSW regulatory team lead may complete the Regulatory Binder. The CRC/A should confirm with their team lead about who will assume the responsibility of the Regulatory binder and updating and maintaining the CRER (See SOP R101a CRER). The team lead will ensure the appropriate institution is credited the start-up time on the transition sheet of the CTS (see SOP Securing Reimbursement for Research Study).
4. RESPONSIBILITIES
Study Coordinator and Back-up Coordinator will be responsible for maintaining regulatory binder throughout the course of the study.
Management of the essential documents fulfils the requirements of Code of Federal Regulations (CFR), guidance that applies to the involvement of human participants in clinical research, Good Clinical Practice (GCP).
The organization of the essential documents fulfills the requirements of Children's Medical Center Research Administration requirements.
5. SPECIFIC PROCEDURE
5.1 Elements of a Regulatory Binder
The following provides an organizational framework and guidance for filing paper versions of essential study documents (or referencing location of an electronically stored file) and to provide a cover page with a description of the required contents for each binder section and where the respective items can be found.
Reference: Good Clinical Practice sections 8.1. 8.2, 8.3, and 8.4
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