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