understanding reporting obligatins to the irb
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DESCRIPTIONReporting to the IRB can mean navigating a maze of regulatory requirements. Staying current on what’s required – and what isn’t – is challenging. In this webinar, Quorum Review’s regulatory expert, Mitchell Parrish, JD, RAC, CIP, helps you concretely understand IRB reporting obligations.
- 1. fully accredited since 2006 May 13 & 15, 2014 Understanding Reporting Obligations to the IRB Mitchell E. Parrish, JD, RAC, CIP Regulatory Attorney
2. 2 3. 3 4. Questions & Answers Feel free to submit questions at any point during the webinar using the chat box on your webinar dashboard Responses will be sent by the presenters following the presentation 4 WEBINAR HOUSEKEEPING 5. Recording & Slide Deck The webinar recording and slide deck will be posted on our website within 5 business days We will email you a link to view the recording as soon as it is available Feel free to share the link with your staff and/or colleagues 5 WEBINAR HOUSEKEEPING 6. ABOUT QUORUM REVIEW IRB 6 ABOUT QUORUM REVIEW IRB Accredited Fully accredited by AAHRPP through 2014 Fully compliant with FDA and OHRP requirements Regulatory Leadership 6 in-house licensed attorneys providing guidance and thought-leadership International Boards available for the review of U.S. and Canadian studies can review for GCP and IHC internationally Strong Framework One of the largest IRBs in the U.S. with ~180 employees Quorum Review is the ONLY equivalently sized IRB not owned by Venture Capital Certified IRB Professionals (CIP) 60% of Affiliated IRB members, 40% of Regulatory staff and 20% of study management & study support positions 7. 15 Board meetings each week 24-hour site turnaround, 36-hour amendment review, and same day site changes One time CV and audit documentation submission Support available 8am-8pm ET Dedicated Study Manager Industry leading legal team 7 THE QUORUM ADVANTAGE 8. Secure portal with SmartForms, status reports, and approval documents Customized Phase I and Expeditable Research processes Flexible, customized process for AMCs Over 850 Institutions work with Quorum 100% Quality Control on all documents Commitment to 6 Sigma Process Analysis 8 THE QUORUM ADVANTAGE 9. Quorum Review Regulatory Attorney Mitchell E. Parrish, JD, RAC,CIP 9 ABOUT THE PRESENTER IRB Experience Joined Quorum Review, Inc. in January 2010 CIP certification Regulatory Affairs Certification Member of Public Responsibility in Medicine & Research (PRIM&R) Legal Background Juris Doctor from University of Oregon Member of the Washington State Bar Association (WSBA) Member of the Association of Corporate Counsel (ACC) and Regulatory Affairs Professionals Society (RAPS) 10. Understanding Reporting Obligations To the IRB Todays Webinar: 11. Role of the IRB 11 Problems with Reporting 15 Regulatory Landscape 18 Obligations for Reporting Safety Information 26 Unanticipated problems that are Adverse Events SUSAR UADE Recommended practices for reporting Safety Information Obligations for Reporting Non-Safety Information 48 Unanticipated Problems that are not Adverse Events Recommended practices for reporting Non-Safety Information Key Take Aways 62 11 Topic Page Webinar Overview 12. Role IRB of The the 12 13. Role of the IRB The primary purpose of both initial and continuing review of [a] study is to assure the protection of the rights and welfare of the human subjects ( 56.109(f). To fulfill its obligations an IRB must have, among other things, information concerning unanticipated problems involving risk to human subjects in the study, including adverse events that are considered unanticipated problems. FDA Guidance for Clinical Investigators, Sponsors, and IRBs, Adverse Event Reporting to IRBsImproving Human Subject Protection (January 2009) 13 14. 14 15. 15 16. 16 Problems with Reporting 17. Problems with Reporting Unnecessary Reporting Much of the information that is being reported does not meet reporting requirements and therefore results in the unnecessary expenditure of resources by all stakeholders. Specifically, the way that unanticipated problem is interpreted does not yield information about adverse events that is useful to IRBs and thus hinders their ability to ensure protection of human subjects. 17 FDA Guidance for Clinical Investigators, Sponsors, and IRBs, Adverse Event Reporting to IRBsImproving Human Subject Protection (January 2009) 18. Problems with Reporting No Explanation Provided 18 Not only is unnecessary information reported, but also reported information is not explained: FDA Guidance for Clinical Investigators, Sponsors, and IRBs, Adverse Event Reporting to IRBsImproving Human Subject Protection (January 2009) In the years since the IRB and IND regulations issued, changes in the conduct of clinical trials (e.g., increased use of multi-center studies, international trials) have complicated the reporting pathways for adverse event information described in the regulations. IN particular the practice of local investigators reporting individual, unanalyzed events to IRBs, including reports of events from other study sites that the investigator receives from the sponsor of a multi-center studyoften with limited information no explanation of how the event represents an unanticipated problemhas led to the submission of large numbers of reports to IRBs that are uninformative. 19. 19 Regulatory The Landscape 20. Regulations (HHS/FDA) 45 CFR 46 (Protection of Human Subjects) 21 CFR 56 (Institutional Review Boards) 21 CFR 312 (Investigational New Drug Application) 21 CFR 320 (Bioavailability and Bioequivalence Requirements) 21 CFR 812 (Investigational Device Exemptions) Guidance (HHS/FDA) HHS, Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events, January 15, 2007 FDA, Guidance for Clinical Investigators, Sponsors, and IRBs, Adverse Event Reporting to IRBs Improving Human Subject Protection, January, 2009 FDA, Guidance for Industry and Investigators, Safety Reporting Requirements for INDs and BA/BE Studies, December, 2012 20 Regulatory Landscape 21. Regulatory Landscape FDA and HHS regulations require the IRB to receive safety and other information throughout study and during continuing review to ensure the criteria for approval is still met and to ensure the safety, rights, and welfare of subjects are protected 21 45 CFR 46.109 and 46.111; 21 CFR 56.109 and 56.111 From Where is the Obligation to Report Safety Information to the IRB derived? 22. Regulatory Landscape There is a lot of safety data and other information in clinical trials, so where in the regulations does it say exactly what to report to the IRB? While the regulations do not contain specifics, they do provide the term Unanticipated Problem (UP) 22 From Where is the Obligation to Report Safety Information to the IRB derived? (continued) 23. Regulatory Landscape Unanticipated Problem 21 CFR 312.66 The investigator shall . . . Promptly report to the IRB . . . All unanticipated problems involving risk to human subjects or others. 21 CFR 56.108(b)(1) [E]ach IRB shall: Follow written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Food and Drug Administration of: (1) Any unanticipated problem . . . . 45 CFR 46.103(b) (4) An IRB must have [W]ritten procedures for ensuring prompt reporting to the IRB , appropriate institutional officials, and the department or agency head of (i) any unanticipated problems involving risks to subjects or others. . . . 23 24. Regulatory Landscape Unanticipated Problem Unanticipated Problem = Any incident, experience, or outcome that meets all of the following criteria: Unexpected (in terms of nature severity or frequency) given(a) the research procedures that are described in the protocol-related documents, and (b) the characteristics of the subject population being studied Related or possibly related to participation in the research Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized HHS Guidance, Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events (January 15, 2007) 24 *Note: This general criteria is essentially the same for unanticipated problems under FDA regulations as well. 1 2 3 25. Regulatory Landscape Unanticipated Problems & Adverse Events In addition to defining Unanticipated Problem, the HHS Guidance also explains that there are UPs that stem from adverse events, essentially safety related UPs, and those that do not stem from adverse events, essentially non-safety related UPs. Adverse Event: Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subjects participation in the research. This encompasses both physical and psychological harms and can be categorized as internal (happening at the site) or external (happening at other locations). FDA Guidance, Adverse Event Reporting to IRBs Improving Human Subject Protection (January 2009) 25 Note: The terms adverse effect and adverse experience are interchangeable with adverse event. 26. Regulatory Landscape Unanticipated Problems and Adverse Events 26 Adapted from HHS Guidance, Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events (January 15, 2007); See also FDA Guidance, Adverse Event Reporting to IRBs Improving Human Subject Protection (January 2009) Safety Related: Do not report adverse events that are not UPs Non-Safety Related: Must report UPs that are not adverse events Safety Related: Must report adverse events that are UPs Under 45 CFR 46 do not report A, do report B + C. 27. 27 Obligations for Reporting Safety Information to the IRB 28. Regulatory Landscape Unanticipated Problems and Adverse Events 28 Adapted from HHS Guidance, Guidance on Reviewing and Reporting