Page 196 - CHST Research Administration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: R015 SOP Title: Study Team Communication
primary CRC or primary CRA. The research coordinator binder will be updated and maintained in an audit ready status through the life of the study.
5.4 Study Regulatory Binder Checklist
Please, refer to Good Clinical Practice E6 chapter 8 for an outline of all essential documents that should be maintained (see also SOP Regulatory Binders). Additionally, please ensure to communicate our department stance and respective Note to File on 1) lab personnel being captured on the delegation of authority log, and 2) who is captured as a sub-investigator in Box 6 of the 1572, kept on shared rive and referenced in SOP entitled Regulatory Binder.
The primary CRC or CRA will maintain all study regulatory binders according to the study sponsor and/or Research Administration. Completion and maintenance of the study regulatory binder checklist is required for all studies. The study regulatory binder checklist will function as a standardized tool to assist in the building of a regulatory binder if a regulatory binder is not provided. If a regulatory binder is provided, the CRC or CRA will complete the study regulatory binder checklist to function as a crosswalk to the sponsor’s layout.
6. RESOURCES
6.1 Study Handoff, Transition & Coverage Facilitation Tool
Study Handoff, Transition & Coverage Facilitation Tool
6.2 Professional, Accountable, Coordinated, Team (P.A.C.T) Tool
Professional, Accountable, Coordinated, Team Tool
6.3 Study Regulatory Binder Checklist
Study Regulatory Binder Checklist
6.4 Study Start-Up Checklist
Shared Drive: T/ CRC resources 2019/ Study Start-Up Checklist
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