- Protocols
- Most current IRB-approved version (clean and tracked)
- All previous versions submitted to IRB (clean and tracked)
- Informed Consents and HIPAA Forms
- Most current IRB-approved version (clean and tracked)
- All previous versions submitted to IRB (clean and tracked)
- Monitoring Plan
- All signed and dated versions
- Financial Disclosure Forms
- All signed and dated versions for Principal Investigator and Sub-Investigators
- Sponsor-Site Agreements
- All signed and dated versions
- FDA Form 1572s (IND Studies)
- All signed and dated versions
- Investigator Agreements (IDE Studies)
- All signed and dated versions
- Investigator Brochures (IB) / Product Package Inserts (PPI) (IND Studies) OR Device Manuals (IDE Studies)
- Most current version(s)
- All previous versions
- IRB Correspondence
- All correspondence with the IRB including but not limited to:
- Submissions (signed and dated versions)
- New
- Modification
- Staff
- Reportable New Information
- Supporting documents (all submitted to IRB)
- Advertisement/ flyers/ recruitment information
- Information given to subjects
- Case Report Form templates
- Letters/ emails from PI
- Letters/ emails from Sponsor
- Audit reports/ findings/ letters
- Adverse Event Logs
- Deviation Logs
- Publications/ Articles/ Abstracts
- Annual Progress Reports (IDE studies)
- Submissions (signed and dated versions)
- All correspondence with the IRB including but not limited to:
- IRB Letters
- All letters from the IRB including but not limited to:
- Reminders
- Contingencies
- Approval
- New submission
- Modification
- Staff
- Continuing Review
- All letters from the IRB including but not limited to:
- Certifications, Accreditations for Medical/ Laboratory/ Technical Procedures/ Tests
- CLIA and CAP certifications for all labs submitting subject results for purpose of the study
- Laboratory values/ normal ranges of study-related lab tests (updated every 2 years)
- Laboratory SOPs, procedure manuals
- CV/ Medical License/ CITI HSPT Training for Lab Director
- Subject Screening-Enrollment Log
- Document chronological screening-enrollment of subjects
- Document reasons why potential subjects were not enrolled as well as screen fails and withdrawals
- Delegation Log
- List of the signatures and initials of all persons authorized on the study
- Document study-related activities that the PI has delegated
- Monitor Site Visit Log
- Log in which monitors will document their visits, to be counter-signed by study staff
- Adverse Event Log
- Comprehensive list of adverse events while subjects are on study (overall or subject-specific)
- Deviation Log
- Comprehensive list of deviations while subjects are on study (overall or subject-specific)
- Specimen Tracking Log
- Comprehensive list of all specimens collected and the shipment information for each specimen
- Requisition sheets for samples obtained
- Investigational Product Information
- Drug/ Device accountability logs
- Shipping and dispensing records
- Calibration and Maintenance records (IDE studies)
- Sample of labels attached to investigational product and materials
- Instructions for handling investigational product and materials
- Case Report Forms
- Case Report Forms, current and retired versions
- Investigator Qualification Documentation (updated copies on file throughout study)
- CVs
- Demonstrates qualifications of Principal Investigator, Sub-Investigators, Medical Monitor, staff
- Copies in file should be signed and dated every 2 years
- Professional License
- Demonstrates qualifications of Principal Investigator, Sub-Investigators, Medical Monitor, staff
- CVs
- Training Documentation (updated copies on file throughout study)
- CITI Human Subjects Training for all delegated study staff
- CITI Good Clinical Practice for PI and Sub-Investigators only
- Study-Specific Training for all delegated study staff, including initial protocol and amendments
- Serious Adverse Events documents
- Copies of SAE Reports and documentation of receipt from IRB, Sponsor, FDA, as applicable
- Copies of IND Safety Reports and documentation of receipt from IRB and FDA, as applicable
- Sponsor Correspondence
- ClinicalTrials.gov information
- Pre-study correspondence, including details of processes and procedures for study conduct
- Monitoring Visit correspondence (including reports, letters, communication)
- Annual Progress Reports
- Record of Final Disposition of Study Records
- Record of Final Disposition of Investigational Drug/ Device
- Correspondence
- Any miscellaneous protocol-related correspondence, including but not limited to:
- Letter of Understanding/ Confidentiality Agreement
- Data Sharing Agreement
- Material Transfer Agreement
- Signed agreements between parties (i.e., sponsors/investigators)
- Important decisions regarding study conduct, such as Notes to File
- Data Safety Monitoring Documents
- Other study documents, as necessary
- Any miscellaneous protocol-related correspondence, including but not limited to:
- Do not file items such as financial records, budget documents, records related to other studies, non-study related personnel records, and auditing reports within the regulatory binder. These documents are usually not open to regulatory agencies.
Create Note-to-File indicating central filing location of documents