Page 25 - CHST Research Administration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE
Research Administration SOP No: R001 SOP Title: Virtual Office Navigator
Study Coordination
Study Finance Management
Regulatory Binder
Laboratory
Pharmacy
Data Management
In addition to the relevant policies and regulations reference in the section 6.3, is an abbreviated (not exhaustive) list of policies and regulations pertaining to study maintenance provided below.
4.5 Study Closure
Prior to study closure the team leads, or quality specialist should work with the CRC to complete an internal quality review. It is imperative that all queries have been resolved, and all reportable events filed and documented for fulfilment of the applicable regulations and concordance with the sponsor and IRB. Further, all study supplies and equipment should be discarded in a manner consistent with the policies and sponsor agreement if applicable; or returned to the sponsor or donor in accordance with the CTA. Documentation of such actions should be filed in the regulatory binder. Upon receipt of a close-out monitor visit and the RA Finance department confirms that all invoices have been paid, the primary coordinator