Page 218 - CHST Research Administration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: R100 SOP Title: Ordering Study Supplies
§ the study title and the Principal Investigator (PI) name
§ the cost center or cost code (if known)
o Once approved, your supply contact person will place the supply order into Lawson. Supply chain will deliver supplies when available (see appendix 1).
4.2 Receiving Study Related Medical Supplies
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.
4.3 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 5.4 (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.
4.4 Disposal of Study Related Medical Supplies
Research study personnel will dispose of unused or expiring/expired study related medical supplies based on the provider of the supplies.
• For study related medical supplies provided by study sponsor/CRO:
o Researchstudypersonnelwilldisposeofexpiring/expiredstudyrelated medical supplies at the written direction of the sponsor/CRO. Research personnel will obtain written direction/authorization to dispose of expiring study related medical supplies if not provided by the sponsor automatically.
o Researchstudypersonnelwillreturnordisposeofexcessstudyrelated medical supplies at the written direction/authorization of the sponsor/CRO at the time of study closure, or as defined by the sponsor.
o Written direction/authorization to return/dispose of sponsor provided study related medical supplies will be maintained within the study regulatory binder under the “Sponsor Communications” tab, or similar category.
o Supplies that the sponsor has requested to “Not be returned” will be donated to non-profit organizations. Research study personnel will adhere to “Supply Chain Operations Department Policy MA3.23, Donation of Medical Supplies & Equipment” when donating unused study related medical supplies.
• For study related medical supplies not provided by the sponsor/CRO (internal purchase using local study budget):