Page 322 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-200
5.6
Cubicle Guidance
1) 2) 3) 4)
All supplies, equipment, and shipping boxes must be clearly labeled to include (sticky notes placed on the box are fine): PI, CRC, IRB#.
Expired supplies must be destroyed or returned to the sponsor within 10 days of expiration. Confirm the plan in writing with your sponsor.
Malfunctioning equipment must be returned to the sponsor within 10 days of expiration.
Studies closed in the IRB:
a. Study supplies/shipping boxes must be returned to the sponsor or discarded (as approved by the sponsor) within 30 days of study closure in the IRB.
b. Study equipment: At the time of study closure, CRC works with sponsor/CRO to return study equipment. If the sponsor determines they do not want the equipment, the PI may want to take possession of the equipment. Record a note to file and attach the sponsor’s written affirmation that the equipment. If the PI wants to retain the equipment, please deliver it to her/his office or desired location. Disposition of the equipment on closed studies must be completed within 30 days of study closure.
c. CLOSED Study records:
i. UTSW CRCs: work with the PI’s department Administrator to store the
documents securely at UTSW. Closed study files will need to be removed from the storeroom within 60 days of study
closure. (EXCEPTION: anticipated FDA inspection. Notify Deborah.town@childrens.com )
ii. CMC CRCs: work with your TL to archive the closed study within 60 days of study closure. (EXCEPTION: anticipated FDA
inspection. Notify Deborah.town@childrens.com )
SUPPLEMENTAL GUIDANCE, RESOURCES, OR FORMS
End Of Summary Worksheet Study Close-Out Checklist
CHANGE HISTORY
SOP Title: Study Closure, Secured Share Drive, Storeroom & Cubicle Guidance
6.
7.
SOP no.
Effective Date
Significant Changes
Previous SOP no.
6