Essential Documents and Regulatory Files Lack of planning can constitute an emergency Rachel Sheppard Regulatory 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 and 21 CFR CFR 812 for devices