Page 319 - eBook Version 8 Book 1 of 2 JUL 2022
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STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-200
5. SPECIFIC PROCEDURE
5.1 Obtain PI, Sponsor & RA Approval to Close-Out Study
5.2 Complete Study Close-Out List (see attachment)
5.3 Complete End of Summary Worksheet on Share drive: RESEARCH\Study eBinders
5.4 Work with PI and TL to prepare the Files for Long Term Storage:
T :\CLINICAL
SOP Title: Study Closure, Secured Share Drive, Storeroom & Cubicle Guidance
5.4.1 Complete Study Close-Out Study: File Retention Algorithm:
Yes
No
Is study FDA Regulated for Marketing of Label?
Yes
Did the study enroll at least 1 subject?
No Yes
No
Complete steps 5.4.2.1-5.4.2.6
Complete steps 5.4.2.1-5.4.2.6
Complete steps 5.4.2.1-5.4.2.6
Label Retain Hard Copy Files with Date the Documents HIPAA- secure document destructed
Has the study been closed for 5 years or more?
Yes
No
Complete steps 5.4.2- 5.4.3
Get Director guidance on file storage location & Store Files Securely (ensure Endo of Summary Worksheet is concordant).
Label Retain Hard Copy Files with Date the Documents HIPAA-secure document destructed
Label regulatory files with: PI Name:
IRB Number:
Date Study Can be broken down: (5 years after study closure)
5.4.2 For studies qualifying to be broken down from the above algorithm in section 5.4.1, schedule time with your TL to:
3
