Page 296 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-110
(e)
(f)
SOP Title: Management of Medical Supplies & Devices
A correct date for shipment and receipt should be established. If a sponsor 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 and delivery.
Upon delivery, follow the protocol, and manual of operations to ensure that the device(s) are inspected and monitored compliantly. Implantable devices will have additional management requirements including:
1) If the device(s) has human, animal or homologous tissue, it must be stored under certain temperature control conditions. For example, these type devices used for cardiology research would be stored in the blood Bank to fulfil storage requirements. However, cardiology device(s) that do not have animal, or human tissue can be maintained in the Core Lab of OR
2) Some studies may require procurement or re-sterilization. This should follow policy and policy with contract and budget terms consistent with the protocol and manual of operating procedures.
For study related medical supplies provided by study sponsor/CRO:
(g)
(i) Study related medical supplies are to be received and tracked utilizing either the sponsor provided inventory checklist or the Research Administration Study Supply Inventory/Expiration Form. Research study personnel will document all information when new study related medical supplies enter their possession and prior to placing into storage or use. Either form must be completed accurately and completely prior to use of any study related medical supplies.
(ii) (iii)
Follow documented process flow provided by the sponsor when ordering or re-ordering study related medical supplies.
Ifasponsorprovidedprocessflowdoesnotexist,contactthestudysponsor/CROfororderingdetails. Place the sponsor/CRO provided details into the regulatory binder for future reference.
(h) For study related medical supplies not provided by study sponsor/CRO:
(i)
(ii)
1) 2) 3) 4)
Ensure that the most recent study service order agreement (SOA) includes funds for medical supplies. Contact the Research Finance Director to assist in determining the availability of funds prior to ordering study related medical supplies.
EmailyourTeamLeader,ResearchFinanceDirectorandRAsupplycontactpersonthatstudyrelated medical supplies are needed for a study and include the following information:
an exact description (size, color, quantity, etc.) of the supplies being requested Omni cell number/Lawson item number
the study title and the Principal Investigator (PI) name
the cost center or cost code (if known)
Once approved, your supply contact person will place the supply order into Lawson. Supply chain will deliver supplies when available (see appendix 1).
(iii)
(i) Ordering Study Related Medical Supplies