Page 195 - CHST Research Administration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: R015 SOP Title: Study Team Communication
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to outline procedures to be followed when documenting and disseminating study training and communication.
2. INTRODUCTION
Communication is a critical component in the success of a study, study team members are expected to communicate effectively and with purpose. Study documentation must be maintained in an audit ready status at all times.
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.
4. RESPONSIBILITIES
4.1 Clinical Research Coordinator(s), Clinical Research Associate(s)
All Clinical Research Coordinators (CRC) and Clinical Research Associates (CRA) will complete all the elements involved with creating, maintaining and communicating study relevant information. All study team training and meetings will be documented and retained with regulatory documents through the life of the study.
5. SPECIFIC PROCEDURE
5.1 Study Handoff, Transition & Coverage Facilitation Tool (Study Handoff Tool)
The CRC and/or CRA will complete and maintain the study handoff tool through the life of every study which they are listed as the primary coordinator or primary research associate. The study handoff tool will be used to supplement transition communication to other staff, and to facilitate study operations in the absence of the primary CRC or primary CRA. The study handoff tool will be started as soon as the study is assigned to the primary CRC or primary CRA. This tool will be updated as the study mandates, and quarterly at a minimum.
5.2 Professional, Accountable, Coordinated, Team (P.A.C.T.) Meeting
The study team will conduct P.A.C.T. meetings as defined in SOP titled PACT. All P.A.C.T. meetings will be documented in a fashion that accurately captures the study teams participation and training provided. P.A.C.T. meeting documentation will be maintained in the study regulatory binder through the life of the study.
5.3 Research Coordinator Manual
The primary CRC or CRA will assemble and maintain a research coordinator binder for each study. The research coordinator binder is to be used as a reference for the study and to facilitate study operations in the absence of the primary CRC or primary CRA. The research coordinator binder will be started as soon as the study is assigned to the
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