Page 97 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: A010 SOP Title: RA Contracts
Agreements\FUA Templates and the tracker is located here: T:\CLINICAL RESEARCH\_Facility Use Agreements.
Once final language is agreed on, the following process occurs:
• Language is finalized
• Entered into LCMS
• Contracts Management routes for internal and external signatures
• Contracts Management sends fully executed copy to RAC and Director
• RAC sends fully executed copy to the PI, research team and Quality Specialists
5.1.1 Once the study team receives notification CHST will be a study site, they should email the Director of RA and copy the Research Administrative Coordinator (RAC) and the Quality Specialists (QS). The email should include: the study title, the STU and Velos numbers, the PI name, the sponsor or CRO name and contact person, along with the contacts email address.
5.1.2 Upon receipt of the email from the study team, the RAC logs the information on the FUA tracker and emails a template to the sponsor. If CHST has previously negotiated an FUA with the sponsor, then a “sponsor specific” template is attached, otherwise, the generic FUA template is attached to the email. The tracker should be updated with every milestone of the contract for tracking purposes.
5.1.3 When the first draft is received from the sponsor/CRO, it is forwarded to the research legal representative for review.
5.2 Data Use Agreements (DUA’s) – A DUA is utilized when a limited data set (clinical data or bio-specimen) leaves the covered entity (CHST) to another organization. A DUA determination is made for research projects where the PI is employed by CHST,
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