Page 320 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-200
SOP Title: Study Closure, Secured Share Drive, Storeroom & Cubicle Guidance
5.4.2.1 Take the study document out of the study binders
5.4.2.2 Review the documents retrieving the original documents for the below files to be stored in a brown accordion file as Retain Hard Copies:
✓ 1572
✓ Financial Disclosure Documents
✓ Protocol Signature Pages
✓ Investigational Brochure signature pages
✓ Delegation of Authority Log
✓ Enrollment Log
✓ Signed informed Consents & HIPAA forms
✓ Bounded documents & CD, or storage file devices, etc.
5.4.2.3 TL: Retain Hard Copies in the brown accordion folder and label the folder with PI Name, STU and/or Legacy IRB numbers, and date the hard copies can be HIPAA- secure, document destructed (i.e., the date the youngest, most recently enrolled subject turns 21 years of age, whichever is more recent).
5.4.2.4 CRC/A: Remove all staples, paper clips, sheet protectors, rubber bands, etc that will not enable scanning from all the documents.
5.4.2.5 CRC/A or TL: Scan the study documents into a respective folder label with PI Last Name_ IRB #, on the Shared drive: T:\CLINICAL RESEARCH\Study eBinders
5.4.2.6 TL: Get permission to HIPAA secured document destruct, and do so upon receipt of approval
5.4.3 TL: Confirm that the End of Summary Worksheet is completed and filed with correct label, PI Last Name_ IRB #, on the shared drive: T:\CLINICAL RESEARCH\Study eBinders:
.1.1 NCT Number
.1.2 Publications
.1.3 CHST or UTSW a site
.1.4 Summary of Results
.1.5 Scan Date
.1.6 HIPAA secured Document Destruction Date: Below is guidance on making an assessment of whether the scanned subjects files can be document destructed in addition with the regulatory files
.1.6.1 Study was terminated
.1.6.2 FDA denied approval
.1.6.3 No efficacy
4