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 / Location
Investigator’s Assurance Statement- Signed by the Lead Researcher and Faculty Sponsor
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 LogIncluding Master Sheet with Identifiers
Recruitment Log
All Subject Files; All Signed Consent Forms for Enrolled Subjects
Consent Process / Location
Consent Documentation (specifying the consent process, any re-consents, etc.)
Staff Signature Log (recording signatures for those eligible to obtain informed consent)
HIPAA Research Authorization Form
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 Study[1]
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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[1] To be forwarded to EQUIP Staff in advance of review session.