Page 547 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Adm-002
SOP Title: Management of Medical Supplies & Devices | Storage Room & Cubicle Guidance
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
N/A PI is acting as sponsor-investigator
N/A Device is under an IDE. If yes, IDE#:
N/A Current signed Investigator Statement (PI name should match the Investigator Statement and the protocol) N/A Previous signed versions of Investigator Statements
N/A Current signed financial disclosure for each investigator
N/A Previous versions of signed financial disclosures for each investigator
N/A Valid licensure for each investigator
N/A Current device manual
N/A Previous versions of or updates to the device manual
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
N/A If device is classified as non-significant risk (NSR), NSR determination was made by:
FDA
Yes
IRB
Yes
N/A If FDA-approved device is being used, current 510(k) N/A If HUD is being used, current HUD brochure
N/A Decoding procedures for blinded trials
N/A Sample device label
N/A Instructions for handling device (if not in protocol or device manual)
N/A Shipping log for each device under investigation, which captures the following:
N/A Date shipment received
N/A Shipment # from packing slip
N/A Batch #/lot #
N/A Expiration date
N/A # of boxes, kits, or devices per lot #
N/A # of devices per box or kit
N/A Condition of study device shipment (intact/damaged)
N/A Receiver’s name
N/A Accountability log for each device under investigation, which captures the following: N/A Participant ID #
N/A Model or serial #
N/A Date device dispensed/administered/used/implemented
N/A Initials of person dispensing/administering/implementing
N/A Date device returned
N/A Initials of person receiving the returned device
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No