essential documents and regulatory files lack of planning can constitute an emergency rachel...
TRANSCRIPT
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