10  Essential Documents & Site Regulatory Binder

10.1 Core Concept

If it isn’t documented correctly, it didn’t happen (from an inspection perspective).

10.2 Essential Document Categories (CRA Monitoring Lens)

• Protocol + amendments
• Investigator’s Brochure (IB) / product information
• Informed consent forms (ICF) + short forms as applicable
• IRB/IEC approvals and correspondence
• Delegation of Authority (DOA) / site signature log
• Training documentation (protocol, GCP, safety, EDC)
• CVs, medical licenses (as required), and financial disclosures (if applicable)
• Normal ranges and lab certifications (central/local labs)
• IP accountability documentation (as applicable)

NoteOncology-Specific Considerations

• Tissue/biopsy logistics often create additional essential documentation (shipping, chain-of-custody, lab manuals)
• Imaging charter or imaging guidance may function as an essential reference for endpoints
• Higher amendment frequency → version control becomes a recurring risk area

NoteVaccine Trial Considerations

• Time-sensitive specimen collection and processing are often critical for immunogenicity and safety endpoints.
• Laboratory manuals and specimen handling instructions must ensure consistency in timing relative to vaccination and follow-up visits.
• Cold-chain handling and accountability documentation may receive additional review during audits or inspections.