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 / 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 Stamped Consent Documents (assent, consent, info. sheet, etc.)
InitialStamped 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)
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 – SponsoredResearch/Grants / Location
Grant Application
Master Protocol and Amendments
Investigator’s Brochure and Updates (retain Out of Date IB’s)
Instructionsfor 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 / 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.)
Signed, Dated and Completed Case Report Forms
Documentation of CRF corrections
Regulatory Documentation / Location
FDA Form 1572 – Completed and Signed
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 / Location
Normal Value/Range(s)
Certification/Accreditation for Facilities
Lab Director’s CV
CLIA Certification
Certification of Analysis
Reports: DSMB and Monitoring Reports / Location
Monitoring Reports and DSMB Reports
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 Study[1]
Copies of Actual Publications/Citations Related to the Current Study

1

[1] To be forwarded to EQUIP Staff in advance of review session.