Page 363 - 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
(vi) ForECGs,orothermedicaldevicesortablets,pleasebesuretocompletetheEquipmentretirement form before shipping the equipment back to the sponsor https://UltimusBPM.childrens.com/ultutil/?ProcessName=Equipment%20Retirement&IncidentNo=42 00&hostName=ultimusbpm1.childrens.med
For study related medical supplies provided by study sponsor/CRO:
(vii) Research study personnel will dispose of expiring/expired study related 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.
(viii) Research study personnel will return or dispose of excess study related medical supplies at the written direction/authorization of the sponsor/CRO at the time of study closure, or as defined by the sponsor.
(ix) Writtendirection/authorizationtoreturn/disposeofsponsorprovidedstudyrelatedmedicalsupplieswill be maintained within the study regulatory binder under the “Sponsor Communications” tab, or similar category.
(x) Suppliesthatthesponsorhasrequestedto“Notbereturned”willbedonatedtonon-profitorganizations. 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.
Section 5.04 For study related medical supplies not provided by the sponsor/CRO (internal purchase using local study budget):
(i) Study related medical supplies that meet criteria set forth in “Administrative Policy AD3.16, Material Returns” may be returned as outlined in AD3.16.
(ii) Study related medical supplies that DO NOT meet the criteria set forth in AD3.16 may 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.
ARTICLE VI. RESOURCES
Section 6.01 Research Administration Study Supply Inventory/Expiration Form
Research Administration Study Supply Inventory/Expiration Form
Section 6.02 Policy tracker
AD 3.16 Supply Chain Operations
Policy 3.23- Donation of Medical Supplies and Equipment