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Regulatory Binder Index Page Device Study.doc

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									REGULATORY BINDER INDEX - Device Studies
         3. APPROVED CONSENT(S)     4. IRB/IEC APPROVALS & CORRESPONDENCE            Clinical Trial Protocol / Substudies Clinical Trial Protocol Amendments Signature pages Device Instructions for Use Curricula Vitae Medical Licenses (US only, if applicable) Financial Disclosure Agreement(s) (if applicable) ID Investigators / Credentials Non-Disclosure Agreement (if applicable) Approved Informed Consent(s)

1. PROTOCOL

2. STUDY PERSONNEL

IRB/IBC/RAC Approvals for Protocol Amendments, Advertisements, Renewals, Substudies, etc. IRB/IEC Correspondence (progress reports, letters of submission for approval, IRB/IEC notification and responses to SAE reports, IND Safety Reports, etc.) IRB/IEC Membership Information or General Assurance Number National Health Authority Approval (where applicable) Lab Certificates (CAP & CLIA) Normal ranges Director’s CV / License Investigator Personnel Team Signature Page Site Monitoring Visit Log(s) Site Signature Log(s) Master Subject Log(s) Screening Log(s) Training Logs (Site Initiation Visit attendance Log and training certificates) Study Related Correspondence between site, sponsor, CRO, etc.

5. LABORATORY

6. STUDY LOGS

7. CORRESPONDENCE



8. SERIOUS ADVERSE EVENTS (SAE)

   

Master SAE Reporting Form and Instructions IND Safety Update Letters Completed Serious Adverse Event Reports (or
note where they are located)

Blank Serious Adverse Event Report Forms Device Accountability Log(s) Device Shipment Receipts Study Supply Forms Miscellaneous (CRF transmittal logs, etc.)

9. DEVICE INVENTORY

   

10. MISCELLANEOUS


								
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