Page 321 - 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
5.5
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2) 3) 4)
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.1.6.4 No active [extension] trials
Storeroom Rules:
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.
Storeroom Layout:
a. The first aisle is for UTSW Coordinators, and should contain their supplies
and study binders, etc.
b. The second aisle and the file cabinets facing in the direction of the doors are
for Children’s coordinators and should contain their supplies and study
binders, etc.
c. The top of the file cabinets should not have anything within 18” of the ceiling
and the space belongs to the Coordinator(s) whose study items are inside the
same cabinet.
d. The third aisle is for closed studies that were managed by CMC staff.
Studies closed in the IRB: we are asking that supplies be limited to what is necessary to cover 3 months (on fast enrolling studies) or 1 month on slow enrolling studies. And we have new storage room rules as spelled out below:
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 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)
d.
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