- Protocol
- Initial protocol and all amendments
- Informed Consent
- All approved versions
- Form 1572
- All versions of Form 1572, signed and dated
- CVs
- Demonstrates qualifications of all investigator and associate investigators
- Updated copies, should be signed and dated
- Serious Adverse Events
- Copies of Reports
- Documentation of receipt from Institutional Review Board, sponsor, Food and Drug Administration, as applicable
- IND Safety Reports
- Copies of reports
- Documentation of receipt from Institutional Review Board
- Institutional Review Board Correspondence
- Regarding approval process of the protocol, amendments
- Submissions, stipulations, responses to stipulations
- Does not need to be entire package
- Keep enough documentation to provide a trail of the process
- Regarding continuing review
- Reminder notices
- Regarding approval process of the protocol, amendments
- Institutional Review Board Letters
- Institutional Review Board approvals
- Continuing review approvals
- Investigator’s brochure (IB)
- All versions of the investigator’s brochure and updates
- Contains scientific information for investigation product
- For Food and Drug Administration approved agents, file a copy of the package insert
- Recruitment advertisements/letters
- With documented Institutional Review Board and sponsor approvals
- Sponsor Correspondence
- Pre-study correspondence as appropriate
- Details processes and procedures for study conduct
- Phone logs
- Site visit letters/summaries
- Correspondence
- Any miscellaneous protocol-related correspondence
- Laboratory Certification
- All copies of CLIA certifications for all labs submitting subject results for purpose of the study.
- Need to have valid certifications filed as long as the study is open
- Subject Enrollment/Screening Log
- Log to document chronological enrollment of subjects
- Log to document patients who entered pre-trial screening period
- Should document why potential subjects were not included in the study.
- Delegation Log
- List of the signatures and initials of all persons authorized on the study.
- Site Visit Log
- Log in which monitors will document their visits
- Site staff will have a place to initial/verify that monitor was present on specific dates
- Pharmaceutical Information
- Drug accountability including shipping and dispensing records
- Sample of labels attached to investigational product containers
- Case Report Forms
- Approved case report forms