ADMINISTRATIVE INFORMATION Principal Investigator: Study Coordinator: Protocol Title: Current Audit Date: Research Compliance Officer (RCO) or Designated Auditor(s): Local VA VA ORD CSP Other VA ORD Sponsor and/or Support: NIH Other Federal: Other: Date of Initial IRB Approval: FDA Regs Apply: Y N Local Protocol Tracking number: Sponsor Protocol Number: or Study Acronym (if any): Drugs/Biologics: IND Req d IND not Req d Devices: NSR IDE Req d IDE not Req d IRB of Record Registration Number: IRB Operated by: Local VA Non-local VA Academic Affiliate VHA Central IRB VA Study Site(s): (check all that apply) Local facility CBOC(s) specify Academic Affiliate Other: Study Type: (check all that apply) Single Site Trial International Study: - ORD/CRADO approval on file? Y N Multi-Center Trial Study involves children? - ORD/CRADO approval on file? Y N Study involves prisoners? - ORD/CRADO approval on file? Y N Category: (check all that apply) Biomedical Behavioral Educational Other: Current IRB Status: Actively enrolling new subjects New enrollments temporarily suspended (check all that apply) Active only for long-term observation Closed to enrollments Active only for long-term data analysis Closed / Terminated Date: For studies with intervention or interaction with living Number of subjects who Unable to determine individuals (regardless of whether identifiable private were entered into the study or number: information was obtained): since initiation: For studies ONLY obtaining identifiable private Number of subjects Unable to determine information (with no intervention or interaction with entered into the study or number: living individuals): since initiation: Research closed NO subjects entered Y N If YES, complete this page only Research closed previous HRPP regulatory audit(s) done Y N If YES, date(s) of previous HRPP audit(s), and complete this page only
PROTOCOL, AMENDMENTS, CONTINUING APPROVAL ETC. IRB SUBMISSIONS, APPROVALS, AND OTHER ACTIONS IRB DATES APPROVAL EXPIRATION RESEARCH & DEVELOPMENT COMMITTEE APPROVAL DATE OR N/A SUBMISSION & APPROVAL LETTERS ON FILE? / N/A Comments
Informed Consent Date Informed Consent Version Number VHA Triennial Regulatory Compliance Audit IRB SUBMISSIONS, APPROVALS, & OTHER ACTIONS INFORMED CONSENT DATE OF IRB APPROVAL Reason for Revision RE-CONSENT REQUIRED? IRB STAMP OR EQUIVALENT Comments
DATE UPR/SAE OCCURRED DATE LEARNED OF EVENT VHA Triennial Regulatory Compliance Audit LOCAL UNANTICIPATED SERIOUS ADVERSE EVENTS (SAES) UNANTICIPATED PROBLEMS INVOLVING RISKS TO SUBJECTS OR OTHERS (UPRS) SIGNIFICANT SAFETY REPORTS / DATA MONITORING COMMITTEE (DMC) REPORTS SUBJECT ID EVENT DATE REPORTED TO IRB REPORTED TO IRB WITHIN REQUIRED TIME PERIOD REVIEWED & CATEGORIZED WITHIN REQUIRED TIME PERIOD CATEGORIZED BY IRB U R S REPORTED TO ORO U Unanticipated R Related to study participation S Serious
STUDY STAFF QUALIFICATIONS AND TRAINING i SITE PERSONNEL HSP/GCP TRAINING COI INFORMATION SECURITY 201 DELEGATION OF AUTHORITY SIGNATURES CV/ RESUME WOC SAFETY TRAINING INITIAL TRAINING NOT COMPLETED PRIOR TO RESEARCH SCOPE OF PRACTICE OR EQUIVALENT DOCUMENTED Role in Study PI/SC FDA Form 1572 P.I.
SUBJECT STUDY ID VHA Triennial Regulatory Compliance Audit SUBJECT RECORD REVIEW ASSESS TIMING OF CONSENT, COMPLIANCE WITH ELIGIBILITY CRITERIA, ETC. TOTAL NUMBER OF SUBJECTS WHO PASSED SCREENING AND WERE INCLUDED FOR ANALYSIS IN STUDY IN THIS PERIOD = IF FEWER THAN 10 SUBJECTS IN THIS PERIOD, AUDIT ALL OF THEM IF 10-100 SUBJECTS IN THIS PERIOD, AUDIT 10 OF THEM IF 101-300 SUBJECTS IN THIS PERIOD, AUDIT 10% OF THEM IF MORE THAN 300 IN THIS PERIOD, AUDIT 30 OF THEM DOCUMENTATION THAT CONSENT OBTAINED PRIOR TO INITIATION OF STUDY PROCEDURES DOCUMENTATION FOUND VERIFYING INCLUSION CRITERIA MET DOCUMENTATION FOUND VERIFYING EXCLUSION CRITERIA NOT MET Subject Included in Research in presence of documentation that inc/excl criteria were not met Other issues found, specify on line below
IRB rules for reporting protocol deviations/violations to IRB: VHA Triennial Regulatory Compliance Audit PROTOCOL DEVIATIONS / VIOLATIONS Deviations, if any, reported to IRB per IRB rules: Yes No Deviations, if any, recorded in compliance with protocol requirements: Yes No NA Drug Device INVESTIGATIONAL PRODUCT ACCOUNTABILITY IN INVESTIGATOR REGULATORY BINDER Product accountability records (storage, inventory, dispensing) maintained? Yes No NA Comments: VAF 10-9012 (Summary Drug Information) on file in the Site regulatory file? Yes No NAComments: Investigator Brochure or Package Insert on File? Yes No NA Comments: Custody & Storage of investigational product (drug and/or device): N/A Pharmacy Investigator Other Complies with the facility requirements or as stipulated by the IRB/R&D Committee? Yes No Comment: OTHER COMMENTS If there anything the RCO/auditor thinks should be noted about this audit, please note/comment here:
Document Investigator Regulatory Files Protocol & Amendments Present and Reviewed Comments AUDIT PREPARATION TOOL Document Investigator Regulatory Files R&D Correspondence Present and Reviewed Comments Approved Case Report Forms Notes-to-File IRB Approved Consent Forms -Information Provided to Subjects -HIPAA Forms -Advertisements -Record of Approved Consent Form Versions Site-Sponsor Correspondence, if app. -Conference call minutes -E-mails -Newsletters -Conference calls -Letters, memos, faxes Subject Log (current/accurate) Study Site Personnel Signatures, Qualifications, Training, Scope of Practice, CVs, Delegation IRB Correspondence Signed Attestation or Investigator s Agreement (Sponsor, Institution, FDA) IRB Submissions, Notifications, Approvals Official Documents Letters, Memos, etc. Serious Adverse Events/Safety Reports Signed PI Conflict of Interest/Disclosure Statement Investigator Brochure/VA Form 10-9012 Investigational Products, if applicable Accountability, Handling, Pharmacy, Elsewhere - Are there local IRB requirements for record keeping? Yes No NA Comments: