or board certifications

GCP training certificates (preferably within 2 years)

Financial Disclosure Forms signed by all key personnel

3. FDA Form 1572 or Local Equivalent

• Correct and current site address
• Accurate listing of all Sub-Is and laboratory information
• Signed and dated by the Principal Investigator

4. Site Delegation of Authority Log

• Each delegated task is listed and matched to authorized staff
• PI has signed the log confirming oversight
• No blank entries or overlapping responsibilities

5. Training Records

• Protocol-specific training logs signed by all attendees
• Site SOP acknowledgment forms (as applicable)
• Technology training for EDC, IWRS, or ePRO systems
• Documentation of vendor or central lab training sessions

6. Informed Consent Forms

• All versions filed with version date and IRB approval stamp
• Translations certified and back-translated if required
• Blank templates for use and signature pages for filing

7. Regulatory Submission Trackers

• Summary of IRB and Competent Authority submissions
• Status of approvals, pending documents, and planned updates

CRA Responsibilities During Document Review

The CRA must:

• Cross-check each document against the site regulatory checklist
• Verify signatures, dates, version control, and compliance status
• Report missing or outdated documents immediately
• File the SIV Document Review Log in the sponsor TMF

Common Documentation Pitfalls to Watch For

• Expired GCP or CV documents
• Incorrect site address on Form 1572
• Missing translations or incorrect ICF versions
• Unlisted staff performing delegated trial activities
• Incomplete training logs or missing attendance records

Best Practices for Document Review

1. Begin the review a few days prior to SIV using pre-submitted scanned copies
2. Bring a sponsor regulatory document checklist to the visit
3. Use digital filing and verification tools, where possible
4. Ensure all critical documents are filed in both ISF and TMF
5. Summarize discrepancies in the SIV Follow-Up Report with corrective timelines

Integration with Sponsor SOPs and Systems

Refer to sponsor-specific SOPs or GMP documentation guidelines for structuring the document review. Many sponsors use electronic Trial Master File (eTMF) platforms with version control, signature tracking, and metadata tagging for every document uploaded. Use version-controlled templates from Pharma SOPs to ensure compliance during regulatory checks.

Preparing for Regulatory Inspections

The reviewed documents must be filed and accessible for inspections from bodies such as the EMA, TGA, or Health Canada. Auditors will verify the completeness, version control, and regulatory relevance of every essential document stored at the site.

Conclusion

Thorough regulatory document review during the Site Initiation Visit is vital to ensure trial readiness and regulatory compliance. By checking each document for accuracy, completeness, and alignment with sponsor expectations, CRAs and site staff can ensure that the trial begins on a strong, auditable foundation. With proper preparation, this process supports a smooth site activation, robust data collection, and successful inspections down the line.