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 Social Behavioral 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. Documentation may be stored
electronically or hard copy. Check those documents that apply to your study, and note the location of
where the document is stored in preparation for your review session.
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 IRB Approved (stamped) Consent Documents (assent, written
consent, information sheet, etc.)
Initial IRB Approved (stamped) Recruitment Materials (flyers, letters,
scripts, text, etc.)
Recruitment of Subjects
Location
Subject Screening Log
Subject Enrollment Log
Subject Enrollment - Coded Log Including Master Sheet with Identifiers
Recruitment Log
All Subject Files; All Signed Consent Forms for Enrolled Subjects
Consent Process
Consent Documentation (specifying the consent process, any re-consents,
etc.)
Location
Staff Signature Log (recording signatures for those eligible to obtain
informed consent)
HIPAA Research Authorization Form
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IRB Documentation – Modifications
Location
IRB Approval Letter for Each Modification Submitted
IRB Approved (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 Approved (stamped) Documents for each Continuing Protocol
Application Submitted
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
the 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
Other Documentation – Qualifications and Publications
Location
Lead Researcher Curriculum Vitae
List of Publications or Citations – Highlight Those Related to the Current
Study1
Copies of Actual Publications or Citations Related to the Current Study
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
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To be forwarded to EQUIP Staff in advance of review session.
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