1. Essential Documents and Regulatory Files Lack of planning can constitute an emergency Rachel Sheppard Regulatory Director, OCRSS

2. 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

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

4. 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

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

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

7. 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

8. References 21 CFR 312.62 and 21 CFR 312.68 21 CFR 812 for devices