Checklist of Clinical Research Documents
Below is a list of common clinical research documents. It is not all-inclusive. Your protocol may have
additional study documents that need to be identified and tracked. Similarly, some of the documents
listed below are optional and may not apply to your study. Check those documents that apply to your
study and note the location of where the document is stored.
Study Protocol
Location
Current Approved Study Protocol
Out-of-Date Study Protocol(s)
Subject Tracking Documents: Screening & Enrollment
Location
Subject Screening Log
Subject Enrollment Log
IRB Documentation
Location
Complete Applications and Documentation for Reviews of New Protocols,
Continuing Reviews, & Amendments
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Complete application
Original IRB action letters and PI responses
Pertinent correspondence regarding review
Final approval letters
Pertinent Correspondence
IRB Tracking Log or Document Log
Manual of Operations
Location
Current Manual of Operations
Out-of-Date Manual of Operations
Informed Consent and Assent Forms
Location
Approved Informed Consent and Assent Forms
Expired/Out of Date Informed Consent and Assent Forms
Consent Revision Log
Recruitment Materials
Location
Recruitment Materials (posters, letters, mailings, thank you’s, etc.)
Out of date recruitment materials
Recruitment Log
Adverse Events & Unanticipated Problems
Documentation of Adverse Events/Unanticipated Problems
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Complete copy of IRB Form
Pertinent correspondence regarding event
Final IRB acknowledgment letter
Regulatory Binder Documentation
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Location
Protocol Deviations and Exceptions
Location
Documentation of Significant Protocol Deviations/Exceptions
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Complete copy of IRB Form
Pertinent correspondence regarding event
Final IRB acknowledgment letter
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Documentation of Minor Protocol Deviations/Exceptions
 Minor deviation documentation (memo-to-file/Deviation log)
Case Report Forms & Study & Subject Documents
Current Case Report Forms (CRFs) (blank)
Out of Date CRFs
List of Source Documents
Study and Subject Documents (blank copy of data collection tools, etc.)
Location
Reports: DSMB and Monitoring Reports
Location
Monitoring Reports and DSMB Reports
Monitoring Log
Documentation of Sponsor Visits (evaluation, initiation, periodic monitoring, closeout)
Regulatory Documentation
FDA Form 1572
FDA Form 1571
IDE Statement of Investigator’s Commitment
Annual Reports
Financial Disclosure Form and Information
Drug/Device Accountability Logs
Sample Label for Investigational Product
IRB Composition
Location
Study Staff Logs and CVs
Location
Roles & Responsibilities Log
Staff Signature Log
Research Staff CVs and Qualifications
Training Documentation Log
Laboratory Documentation
Normal Value/Range(s)
Certification/Accreditation for Facilities
Lab Director’s CV
CLIA Certification
Certification of Analysis
Regulatory Binder Documentation
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Location
Investigational Brochures
Location
Current Investigational Brochures
Out of Date Investigational Brochures
Investigational Brochure updates
IRB acknowledgment of new Investigational Brochures/updates
Study Drug/Device
Shipping records (dates, batch numbers, methods)
Accountability logs
Randomization code
Location
Scientific Review
Documentation of Scientific Review
Location
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Copies of scientific reviewer worksheets
Copies of pertinent correspondence
Documentation of department/division approval
Subject Case Histories
Location
Signed informed consent/assent forms
Signed, dated and completed case report forms
Documentation of CRF corrections
Source documents
Investigator Agreement
Investigator Agreement
Confidentiality agreement b/w investigator & sponsor
Insurance or indemnification letter
Location
Miscellaneous
Equipment and Supplies (receipt, calibration and maintenance logs)
Financial agreements (budget contracts)
Location
Regulatory Binder Documentation
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