Page 301 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-110
SOP Title: Management of Medical Supplies & Devices
Investigators may use this checklist to conduct a self-audit or to prepare for a monitoring visit, compliance review, or audit.
IRB STU # Protocol Title Principal Investigator Department Sponsor Velos # List of All Performance Sites Person Completing Checklist Date Checklist Completed
PI is acting as sponsor-investigator
Device is under an IDE. If yes, IDE#:
Current signed Investigator Statement (PI name should match the Investigator Statement and the protocol) Previous signed versions of Investigator Statements
Current signed financial disclosure for each investigator
Previous versions of signed financial disclosures for each investigator
Valid licensure for each investigator
Current device manual
Previous versions of or updates to the device manual
Yes
Yes
If device is classified as non-significant risk (NSR), NSR determination was made by:
FDA
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
N/A
No
N/A
Yes
No
N/A
Yes
Yes
Yes
No
No
N/A
N/A
Yes
Yes
No
No
N/A
N/A
No
N/A
Yes
Yes
No
N/A
No
N/A
IRB
Yes
No
N/A
If FDA-approved device is being used, current 510(k) If HUD is being used, current HUD brochure Decoding procedures for blinded trials
Sample device label
Instructions for handling device (if not in protocol or device manual)
Shipping log for each device under investigation, which captures the following:
Date shipment received
Shipment # from packing slip
Batch #/lot #
Expiration date
# of boxes, kits, or devices per lot #
# of devices per box or kit
Condition of study device shipment (intact/damaged) Receiver’s name
Accountability log for each device under investigation, which captures the following: Participant ID #
Model or serial #
Date device dispensed/administered/used/implemented Initials of person dispensing/administering/implementing Date device returned
Initials of person receiving the returned device
Yes
No
N/A
N/A
N/A
N/A
No
N/A
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Yes
Yes
No
No
N/A
N/A
N/A
No
No
N/A
N/A
No
N/A
Yes
No
N/A
Yes
Yes
Yes
Yes
No
No
No
N/A
N/A
N/A
No
N/A
Yes
No
N/A