EDUCATION & QUALITY IMPROVEMENT PROGRAM
OFFICE OF RESEARCH
5171 California Blvd., Suite 150
Irvine, CA 92697-7600
Phone: (949) 824-4768
Fax: (949) 824-1465
http://www.research.uci.edu/compliance/human-research-protections/index.html
EQUIP Expectations for Biomedical Researchers
Below is a list of common study documents, although it may not be all-inclusive. Every protocol may
have additional study documents that may need to be identified and tracked. Similarly, some of the
documents listed below are optional or may not apply to every study. In preparation for your review
session, please check those documents that apply to your study, and note the location of where the
document is stored. Documentation may be stored electronically or hard copy.
IRB Documentation – Initial Study Submission
Investigator’s Assurance Statement- Signed by the Lead Researcher and
Faculty Sponsor
Location
Disclosure of Investigators’ Financial Interests – Signed by the Lead
Researcher
Department or Organized Research Units (ORU) Assurance Statement –
Signed by the Department Chair or ORU Director
Initial Application for IRB Review
Pertinent correspondence with IRB Staff directly pertaining to IRB
submission(s)
Initial IRB Approval Letter
Initial IRB Approved (stamped) Protocol Narrative
Initial Stamped Consent Documents (assent, consent, info. sheet, etc.)
Initial Stamped Recruitment Materials (flyers, letters, scripts, text, etc.)
Recruitment of Subjects
Location
Recruitment Log
Subject Screening Log – Indicate if direct identifiers
Subject Enrollment Log - Indicate if direct identifiers
All Subject Files; All Signed Consent Forms for Enrolled Subjects
All Subject Files; All Signed HIPAA Research Authorization Forms for
Enrolled Subjects (when protected health information is involved)
Consent Process
Location
Consent Documentation (specifying consent process, any re-consents, etc.)
Signature Log for Study Staff (recording signatures for those eligible to
obtain informed consent)
1
IRB Documentation – Modifications
Location
IRB Approval Letter for Each Modification Submitted
IRB Stamped Documents for each Modification Submitted
Pertinent correspondence with IRB Staff directly pertaining to IRB
submission(s)
IRB Documentation – Continuing Protocol Application
Location
IRB Approval Letter for Each Continuing Protocol Application Submitted
IRB Stamped Documents for each Continuing Protocol Application
Pertinent correspondence with IRB Staff directly pertaining to IRB
submission(s)
IRB Documentation – Adverse Event / Unanticipated Problem Report
Location
Copy of Each Adverse Event / Unanticipated Problem Report Submitted
Copy of Each Tracking Log for Non Reportable Events, Acknowledged by IRB
Documentation of Subject Complaint and Resolution
Pertinent correspondence with IRB Staff directly pertaining to IRB
submission(s)
Other Documentation - Procedures
Location
Evidence of Compensation or Payment of Subject
Data Collection Sheet(s), Completed Questionnaires or Surveys
Study Visit Log
Other Documentation – Sponsored Research/Grants
Location
Grant Application
Master Protocol and Amendments
Investigator’s Brochure and Updates (retain Out of Date IB’s)
Instructions for Handling of Investigational Product/s & Trial-Related
Materials [indicate if not included in protocol or Investigator’s Brochure]
Relevant Communications
Case Report Forms & Study & Subject Documents
Current Case Report Forms (CRFs) (blank)
Location
Out of Date CRFs
List of Source Documents
Study and Subject Documents (blank copy of data collection tools, etc.)
Signed, Dated and Completed Case Report Forms
Documentation of CRF corrections
2
Regulatory Documentation
FDA Form 1572 – Completed and Signed
Location
FDA Form 1571 – Completed and Signed
IDE Statement of Investigator’s Commitment
FDA Annual Reports
FDA Financial Disclosure Form and Information
Sample Label for Investigational Product
Study Drug/Device
Location
Shipping records (dates, batch numbers, methods)
Drug/Device Accountability Logs
Randomization code
Laboratory Documentation
Normal Value/Range(s)
Location
Certification/Accreditation for Facilities
Lab Director’s CV
CLIA Certification
Certification of Analysis
Reports: DSMB and Monitoring Reports
Monitoring Reports and DSMB Reports
Location
Monitoring Log
Sponsor Visit Documentation (evaluation, initiation, monitoring, close-out)
Other Documentation - Clearances & Approvals
Location
Evidence of Clearance from Other UCI Committees
NIH Certificate of Confidentiality (COC) Approval Letter
Letter(s) of Permission
Current IRB Approval Letters from Collaborating Sites
Prisoner Research (DHHS Funded): A Certification Letter from OHRP
Other Documentation – Qualifications and Publications
Location
Lead Researcher and Co-Investigator Curriculum Vitae
List of Publications/Citations – Highlight Those Related to Current Study1
Copies of Actual Publications/Citations Related to the Current Study
1
To be forwarded to EQUIP Staff in advance of review session.
3