Summary
Highlights
This section contains the Investigator Brochure receipt, which is signed by the PI, and the Investigator Brochure itself, including any subsequent amendments.
This section is divided into general training and certifications (GCP, IATA for relevant staff), study-specific training records (e.g., SIV training logs, protocol amendment training), and study-specific training materials (sponsor-provided slides).
This section includes the delegation of authority log, screening and enrollment log, protocol deviation log, subject identification log, and other miscellaneous documents like source mapping and guidance.
This section contains IRB approvals, IRB submissions (e.g., privacy statements, EDC terms of use), IRB correspondence, the latest and all versions of informed consent, IRB membership list and compliance statement, and additional IRB-approved subject-facing materials (patient rating scales, study instructions, advertising material).
This segment covers the remaining sections: Section 8 (Investigational Supplies documentation), Section 9 (Clinical Laboratory information like lab reference manuals), Section 10 (SAEs and safety reports), Section 11 (Monitoring activities and reports), Section 12 (Electronic Data Capture documentation, user access requests, digital signatures), Section 13 (Site Communication emails with sponsors/CROs), Section 14 (Agreements, with a note about where contracts are typically stored), and Section 15 (Miscellaneous documents such as SOPS, equipment calibration, and notes to file).
The speaker concludes by emphasizing that maintaining the investigator site file is an ongoing process due to continuous updates and new information. He encourages viewers to like, subscribe, comment, and share the video.
This section covers the 1572 form (all versions), financial disclosure statements for all sub-investigators and the PI, CVs for all staff, and medical licenses. The speaker also corrects a misfiling regarding a COVID statement.
This section includes protocol and amendments, specifically signature pages for the protocol (for both coordinators and the PI), and the actual protocol documents along with all amendments. Emphasis is placed on ensuring the most recent version of the protocol is always present and that staff are trained on new amendments.
The video begins with an introduction to the investigator site file, also known as a regulatory binder. The speaker references an electronic regulatory system and mentions a book he authored that discusses regulatory aspects.
This section details the site communication matrix, which lists all key personnel involved in the study, including the CRA, project manager, in-house CRA, and medical monitor. It helps the site know who to contact for study-related issues.