Introduction
Subject Screening and Enrollment
Informed Consent and Assent Forms
Memos-to-File
Adverse Events and Reportable Events
Protocol Deviations and Exceptions
Data and Safety Monitoring
Recruitment Materials
Protocol
CRFs, Study, and Subject Documents
Study Staff Logs and Curriculum Vitae
IRB Documentation
Scientific Review
FDA Forms 1571/1572, or IDE: Statement of Investigator Commitment
Regulatory Documentation: Sponsor-Investigator IND/IDE Holder
Regulatory Documentation: Investigator
Monitoring Logs/Reports
Drug/Device Accountability Log
Laboratory Documentation
Investigational Brochure/Package Insert/Device Manual
Study Closure
