Page 362 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Rec-004
SOP Title: Management of Medical Supplies & Devices
b) She will work to get approval to stock the supplies in the Omnicell by the clinical manager and coordinate a maintenance and disposal process (please adhere to the relevant policies regarding supply and medicine ordering, tracking and disposal).
Section 5.02 Receiving & Study Related Medical Supplies
Investigational Medical Devices (see a sample SOP for a particular study)
Complete the Device Management Checklist (see attached)
(a) Once checklist has been completed and all approvals granted: send template email to PI, sponsor, purchasing contact, supply chain contact, and ancillary manager where that the device was received, what condition it was found in, where it will be stored (if not returned) along with a photograph of the device.
(b) Place, the device in its designated space along with a folder containing the study SOP, accountability log, and contact information. It should be marked FOR RESEARCH ONLY | PLEASE, CONTACT DR. X, or CRC XX.
(c) Be sure to follow any procedures required for your study, such as temperature monitoring, labelling, sterilization, etc.
(d) Set a calendar reminder to complete a monthly attestation of the device to ensure it is still its place, is intact, and has not expired or is not due for re-sterilization.
(e) Maintaining Study Related Medical Supplies
Research study personnel will maintain study related medical supplies in such a fashion to ensure that expiring/expired supplies are removed from current stock, documented and disposed of as outlined in Procedure 5.3 (below). Documentation must occur at the time of disposal on the Research Administration Study Supply Inventory/Expiration Form, or on the sponsor provided inventory checklist.
Section 5.03 Retiring, Returning, or Disposal of Study Related Medical Devices & Supplies
Investigational Medical Devices (see a sample SOP for a particular study)
(i) CompletetheDeviceManagementChecklist(seeattached)
(ii) Once checklist has been completed and all approvals granted: coordinate with your PI, team lead, sponsor, purchasing manager (if applicable), and ancillary manager when the device will be returned.
(iii) Once a correct date for shipment and shipping materials has established, or obtained, complete the documentation and accountability log for the return shipment of the medical device and file in the regulatory binder.
(iv) Takephotographsofthedevicesbeforetheywereshippedanddocumenttheircondition.Ifasponsor representative is needed to be present to inspect the device upon delivery, or there are particular temperature of shipping requirements these should be included in the date of selection and logistics of the shipment.
(v) Upon shipment, follow the protocol, send an email to the PI, team lead, sponsor, purchasing manager (if applicable), and ancillary manager that the device was returned.