Page 238 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-106 SOP Title: Lab Bags/Kits
5. SPECIFIC PROCEDURE
5.1 Maintaining Lab Supply Inventory:
Some sponsor’s will auto-supply the lab kits. In other words, the sponsor will send a certain number of lab kits and shipment materials in advance of or in response to enrollment to the address on file.
1. Review the protocol, consider study enrollment, and determine if there is an auto-supply schema and whether it is necessary to contact the sponsor to make an adjustment.
2. On at least a monthly basis, inventory should be taken of all lab supplies including:
a. Number of Lab Kits
b. Name of Lab Kits
c. Expiration Dates of Lab Kits
d. Number of Needed Lab Kits
e. Number of Shipment Materials
3. Notify
the sponsor and resolve any discrepancies.
4. Document all lab supplies, orders for lab supplies, and shipment tracking information on the laboratory inventory log (see appendix).
When the sponsor does not auto-supply the lab supplies, the following procedures must be completed in order to maintain an adequate inventory of lab supplies:
1. Review the protocol, lab manual, and enrollment to assess study needs and lab collection schedule.
2. Make a lab supply order plan to ensure that lab supplies will be kept current and cover the demands of the study.
3. For all lab supplies provided by the sponsor, follow the sponsor provided protocol for ordering lab supplies.
4. For all additional lab supplies:
a. Determine the allowance for supplies on the service order agreement (SOA).
b. Prioritize the supply list.
c. Submit the supply list to the department supply coordinator and the financial analyst responsible for ordering supplies (see SOP D030) including the prioritized supply list, the quantity of the supplies, along with the IRB number and PI last name.
d. Track the order.
e. Document all lab supplies, orders for lab supplies and shipment tracking information.
f. Repeat this process on a monthly basis, or in a manner that supports the needs of the study throughout the duration of the study.
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