Page 149 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-100 SOP Title: Regulatory Binder
External Site Regulatory Documents (if applicable) FDA Correspondence (if applicable)
Monitoring Plan (if applicable)
Additional nested folder structure within sub-folders listed above (on-going goal):
1. Internal Reviews
➢ PSR (Performance Site Review)
➢ SHUR RSC (Radiation Safety Committee) - if applicable
o Amendments
o Continuing Reviews
o Initial Submission
o Other Correspondence
2. IRB
➢ CIRB (if applicable)
o Amendments
o Continuing Reviews
o Initial Submission
o Other Correspondence o Reportable Events
➢ UTSW IRB
o Amendments and Modifications o Continuing Reviews
o Initial Submission
o Other Correspondence
o Reportable Events
3. Essential Documents
➢ 1572 – if applicable
➢ FDF’s (Financial Disclosure Forms) – if applicable
➢ IB Signature Pages – if applicable
➢ Protocol Signature Pages – if applicable
4. Protocol
➢ Current approved version
➢ Previous versions
5. IBBrochure
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