How To Create An Electronic Regulatory Binder In Sharepoint Page 4


Attachment 2: Examples of sub-folders for you eRegulatory Binder. Please create sub-folders
applicable to your study.
Current Protocol
Outdated Protocols
Current ICF & HIPAA Authorization Form
Outdated ICF & HIPAA Authorization Form
Investigator’s Brochure
Investigator’s Agreement
IRB Correspondence (IRB submissions and letters)
Other Committee Correspondence
Delegation of Authority Log
FDA Form 1572
Financial Disclosure Forms
CVs, Licenses, Training Certificates for PI, Sub-Is, Key Personnel
Protocol Deviation Log
Serious Adverse Events (SAEs)
IND/IDE Safety Reports
Laboratory Certification
Subject Enrollment/Screening Log
Site Visit Log
Specimen Sample Logs
Pharmaceutical Information
Case Report Forms
Sponsor Correspondence
General Correspondence
For a more detailed list of sub-folders email:


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