Page 486 - eBook Version 8 Book 1 of 2 JUL 2022

Site Initiation Visit Research Administration SOP No: R-Com-201 SOP Title: Site Initiation Visit
• Review/audit of regulatory documents
• Review/accounting of site resources/supplies
• Confirmation of study team credentialing (Good Clinical Practice (GCP), Human
Subjects Protection (HSP), Health Insurance Portability Accountability Act
(HIPAA) etc.,)
• Confirmation protocol specific training for the study team
• 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 Documentation of GCP/ICH trainings of each study team member
o CVs, study team credentials and licensure
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
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