Essential Documents and Regulatory FilesLack of planning can constitute an emergency

Rachel SheppardRegulatory Director, OCRSS

Regulatory Packet• Sponsors send• Financial disclosure forms• Investigator agreement (device trials)• 1572 form (drug trials)• ICF template• Protocol• IB• Lab/imaging manual• Budget template• Other documents

Regulatory Packet• Sites submit• CVs• Licenses• Laboratory information• Completed forms from sponsor packet• Draft ICF

Regulatory Binder• Delegation log• Training log/documentation• CVs and licenses• Laboratory information• IRB correspondence and approvals• Hospital approval letters• Protocol and IB• Correspondence• SOPs (if applicable)• Monitoring records/reports

Regulatory Binder• Not in the file• Financial information• Clinical information (varies based on responsibilities)• PHI

Regulatory vs. Clinical files• Delegation log• Training information• Laboratory manual• Pharmacy manual• Manuals of operation• CRF instructions

Best practices• Be consistent• Know your SOPs• Changes in practice in writing with dates• Stand your ground• Avoid excessive notes to file• Ensure review• Keep secure• Touch each document once

References• 21 CFR 312.62 and 21 CFR 312.68 • 21 CFR 812 for devices