Page 145 - CHST Research Administration eBook 2 of 2 (Q4 2021)

Site Initiation Visit Research Administration SOP No: R010 SOP Title: Site Initiation Visit
• Issuance/closure of outstanding items
The sponsor/CRO/sponsor agent may include the following when meeting with the study team to discuss the following:
• Study protocol
• Review instructions on any study-specific procedures
• Review of Case Report Form (CRF) / electronic CRF completion
• Expectations of safety and timely reporting to regulatory agencies
• Documentation of study-related trainings
• Audit of regulatory documentation/paperwork, such as:
o Delegation of Authority Log, listing each study team member’s responsibilities
o FDA 1571/1572 (if device or drug trial) (Please, file the departmental Note to File regarding who is defined as a sub investigator in box 6 of the 1572; Please, also ensure that the departmental Note to File documenting that Lab personnel are not study personnel and not listed on the Delegation of Authority (DOA) log).
o DocumentationofGCP/ICHtrainingsofeachstudyteammember
o CVs,studyteamcredentialsandlicensure
o Sponsor-specific training logs, financial disclosure documents or
significant correspondence
The sponsor/CRO/sponsor agent may request to meet with the following to discuss:
• Investigational Pharmacy/Investigational Drug Services (if the study is a drug trial)
o Review study drug/investigational product (IP) storage location, regulatory monitoring of pharmacy-specific documents, review of IP logging and destruction SOPs, review of study-specific trainings
• Research Laboratory (if biological specimens are being obtained as part of the study)
o Review of study-specific sample collection/sample processing, sample shipment procedures, storage conditions and monitoring for samples
The Sponsor will generate a report upon visit completion to notify the site that they have been approved to begin screening or if further action items need to be addressed prior to site activation
Once site activation has been issued by the sponsor, ensure that performance site approval has been granted by CHST initiate patient recruitment
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