Page 464 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Com-101
SOP Title: P.A.C.T
1. PURPOSE
The purpose of the current standard operating procedure (SOP) is to outline the procedures for holding a P.A.C.T. (Professional Accountable Coordinated Team) meeting to ensure effective communication within the study team.
2. INTRODUCTION
The P.A.C.T (Professional Accountable Coordinated Team) is a tool to help all those who are conducting clinical research within a study team create and maintain an effective P.A.C.T. team. The use of this tool is meant to be individualized for each study and designed in such a way that it supports study team. Study initiatives including, but not limited to; defining the study roles and tasks, discussing all study related events and important subject information updates, and study management, may be developed and carried out in such a way that makes most sense for the study and study team.
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, Amanda Lee, Amanda.lee@UTSouthwestern.edu may part of the initial study team. The CRC/A should confirm with their team lead about the study transition. The team lead will ensure the appropriate institution is credited the start-up time on the transition sheet of the CTS (see SOP CTS and Transition Time Sheet).
4. RESPONSIBILITIES
4.1 Roles
• Primary Coordinator
• Back-up Coordinator
• Co-Coordinator
• Data Support
• Research Associate
• Research RN
• Research RRT
• Medical Assistant
• Other (specify)
• PI/Co-PI
4.2 Responsibilities
• IRB/Regulatory/Budget submission/Coordinator binder • Screen
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