Table 4.

Clinical trial study documents

No.Document typeExamples
1Regulatory• FDA Form 1572
• Dated Curriculum vitae for each investigator
• Medical license
• Study protocol and/or amendments, signed by investigator
• IRB approval(s) of protocol and/or amendments
• IRB approval(s) of informed consent form
• List of IRB members and affiliations
• Sponsor (or FDA) notification(s) of serious adverse events
• IRB notification(s) of serious adverse events
• IRB notifications of trial progress, study closure, etc.
• Laboratory normal ranges
• Laboratory certifications
• Delegation of Authority Form
• Study Staff Signature Sheet
2Product Accountability• Shipment and receipt records
• Inventory and dispensing log
• Reconciliation log
• Freezer temperature chart (if applicable)
3Other Documentation• Investigator Brochure(s), including out-of-date versions
• Monitoring reports and sign-in log
• Investigator correspondence
• Enrollment log
• Investigator-Institutional Agreement
• Insurance-Indemnification Record
• Financial Disclosure Form
• IND Safety Reports
• Documentation of protocol training
• Documentation of investigator training