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 / LocationCurrent 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Out-of-Date Study Protocol(s)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
§ 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Out-of-Date Manual of Operations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Expired/Out of Date Informed Consent and Assent Forms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Out of date recruitment materials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 / Location
Documentation of Adverse Events/Unanticipated Problems
§ Complete copy of IRB Form
§ Pertinent correspondence regarding event
§ Final IRB acknowledgment letter
Protocol Deviations and Exceptions / Location
Documentation of Significant Protocol Deviations/Exceptions
§ Complete copy of IRB Form
§ Pertinent correspondence regarding event
§ Final IRB acknowledgment letter
Documentation of Minor Protocol Deviations/Exceptions
§ Minor deviation documentation (memo-to-file/Deviation log)
Case Report Forms & Study & Subject Documents / Location
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Out of Date CRFs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.)
Reports: DSMB and Monitoring Reports / Location
Monitoring Reports and DSMB Reports
Monitoring Log
Documentation of Sponsor Visits (evaluation, initiation, periodic monitoring, close-out)
Regulatory Documentation / Location
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
Study Staff Logs and CVs / Location
Roles & Responsibilities Log
Staff Signature Log
Research Staff CVs and Qualifications
Training Documentation Log
Laboratory Documentation / Location
Normal Value/Range(s)
Certification/Accreditation for Facilities
Lab Director’s CV
CLIA Certification
Certification of Analysis
Investigational Brochures / Location
Current Investigational Brochures
Out of Date Investigational Brochures
Investigational Brochure updates
IRB acknowledgment of new Investigational Brochures/updates
Study Drug/Device / Location
Shipping records (dates, batch numbers, methods)
Accountability logs
Randomization code
Subject Case Histories / Location
Signed informed consent/assent forms
Signed, dated and completed case report forms
Documentation of CRF corrections
Source documents
Investigator Agreement / Location
Investigator Agreement
Confidentiality agreement b/w investigator & sponsor
Insurance or indemnification letter
Miscellaneous / Location
Equipment and Supplies (receipt, calibration and maintenance logs)
Financial agreements (budget contracts)