fully accredited since 2006
May 13 & 15, 2014
Understanding Reporting Obligations
to the IRB
Mitchell E. Parrish, JD, RAC,...
2
3
• Questions & Answers
• Feel free to submit questions at any point
during the webinar using the chat box on your
webinar d...
• Recording & Slide Deck
• The webinar recording and slide deck will be
posted on our website within 5 business days
• We ...
• ABOUT QUORUM REVIEW IRB
6
ABOUT QUORUM REVIEW IRB
Accredited
Fully accredited by AAHRPP through 2014
Fully compliant wit...
• 15 Board meetings each week
• 24-hour site turnaround, 36-hour amendment review,
and same day site changes
• One time CV...
• Secure portal with SmartForms, status
reports, and approval documents
• Customized Phase I and Expeditable
Research proc...
Quorum Review Regulatory Attorney
Mitchell E. Parrish, JD, RAC,CIP
9
ABOUT THE PRESENTER
IRB Experience
 Joined Quorum Re...
Understanding Reporting
Obligations To the IRB
Today’s Webinar:
Role of the IRB 11
Problems with Reporting 15
Regulatory Landscape 18
Obligations for Reporting Safety Information 26
Unan...
Role
IRB
of
The
the
12
Role of the IRB
The primary purpose of both initial and
continuing review of [a] study is ‘to assure the
protection of the...
14
15
16
Problems
with
Reporting
Problems with Reporting – Unnecessary Reporting
Much of the information that is being reported does not
meet reporting req...
Problems with Reporting – No Explanation Provided
18
Not only is unnecessary information reported, but also reported infor...
19
Regulatory
The
Landscape
Regulations (HHS/FDA)
• 45 CFR 46 (Protection of Human Subjects)
• 21 CFR 56 (Institutional Review Boards)
• 21 CFR 312 (I...
Regulatory Landscape
FDA and HHS regulations require the IRB to receive safety and other
information throughout study and ...
Regulatory Landscape
There is a lot of safety data and other information in clinical trials, so where
in the regulations d...
Regulatory Landscape
Unanticipated Problem
21 CFR 312.66 – “The investigator shall . . .
Promptly report to the IRB . . . ...
Regulatory Landscape
Unanticipated Problem
Unanticipated Problem = Any incident, experience,
or outcome that meets all of ...
Regulatory Landscape
Unanticipated Problems & Adverse Events
In addition to defining “Unanticipated Problem,” the
HHS Guid...
Regulatory Landscape
Unanticipated Problems and Adverse Events
26
Adapted from HHS Guidance, Guidance on Reviewing and Rep...
27
Obligations for
Reporting Safety
Information
to the IRB
Regulatory Landscape
Unanticipated Problems and Adverse Events
28
Adapted from HHS Guidance, Guidance on Reviewing and Rep...
Reporting Safety Information to the IRB
29
SUSAR:
SERIOUS & UNEXPECTED SUSPECTED
ADVERSE REACTIONS
UP:
UNANTICIPATED PROBL...
Reporting Safety Information - SUSAR
Serious and unexpected suspected adverse reaction (SUSAR) originates from 21 CFR 312
...
Reporting Safety Information - SUSAR
Individual Occurrences
A single occurrence of an event that is
uncommon and known to ...
Reporting Safety Information - SUSAR
32
In a phase II study testing an
investigational drug for Hepatitis C, a
subject exp...
Reporting Safety Information - SUSAR
In a phase II study testing an
investigational drug for Hepatitis C, a
subject experi...
Reporting Safety Information - SUSAR
34
One or more Occurrences
One or more occurrences of an event that is
not commonly a...
Reporting Safety Information - SUSAR
35
Is this one occurrence a suspected adverse reaction?
Example:
A subject with extra...
Reporting Safety Information - SUSAR
36
Is this one occurrence a suspected adverse reaction?
Example:
A subject with extra...
Reporting Safety Information - SUSAR
37
Aggregate Analysis of Specific Events
An aggregate analysis of specific events obs...
Reporting Safety Information - SUSAR
17 oncology sites are participating in a
research study comparing an investigational
...
Reporting Safety Information - SUSAR
17 oncology sites are participating in a
research study comparing an investigational
...
Reporting Safety Information - SUSAR
Critical to understand the
definition of “Suspected
Adverse Reaction” coupled
with th...
Reporting Safety Information - SUSAR
Without this understanding, the FDA
explains that the following problem occurs:
Repor...
Reporting Safety Information - UADE
42
Unanticipated Adverse Device Effect
(UADE) originates from 21 CFR 812 and is
design...
Reporting Safety Information - UADE
FDA Guidance for Clinical Investigators, Sponsors, and IRBs,
Adverse Event Reporting t...
Recommended Practices for Reporting Safety Information
For Multi-center studies:
44
FDA Guidance for Clinical Investigator...
Recommended Practices for Reporting Safety Information
 While Investigators may report SUSARs and UADEs to the IRB,
Quoru...
Recommended Practices for Reporting Safety Information
For single-center or
investigator initiated studies:
46
 The inves...
Recommended Practices for Reporting Safety Information
47
(continued) 
Report SUSARs and
UADEs “promptly” to
the IRB “Prom...
Recommended Practices for Reporting Safety Information
48
(continued) 
• What to report
• Whether to report
• How to repor...
49
Obligations for
Reporting
Non-Safety
Information
to the IRB
Unanticipated Problems and Adverse Events
50
Adapted from HHS Guidance, Guidance on Reviewing and Reporting Unanticipated ...
51
Reporting Non-Safety Information to the IRB
UNEXPECTED
UP:
UNANTICIPATED 
PROBLEM
You MUST report ALL 
UP’s to the IRB
...
52
Reporting Non-Safety Information to the IRB
• Failure to obtain informed consent
• Major protocol deviations (e.g.
incl...
53
Reporting Non-Safety Information to the IRB
An investigator is conducting behavioral research and collects
individually...
54
Reporting Non-Safety Information to the IRB
YES
An investigator is conducting behavioral research and collects
individu...
An Investigator is conducting a psychology study
evaluating decision making and response times when
persons are listening ...
56
Reporting Non-Safety Information to the IRB
NO
An Investigator is conducting a psychology study
evaluating decision mak...
57
Reporting Non-Safety Information to the IRB
Is this reportable to the IRB as a UP?
As a result of a processing error by...
58
Reporting Non-Safety Information to the IRB
YES
Is this reportable to the IRB as a UP?
As a result of a processing erro...
Recommended Practices for Reporting Non-Safety Information
For multi-center or single-center:
 Generally, UPs that are no...
Recommended Practices for Reporting Non-Safety Information
60
(continued) 
Report UPs “promptly”
to the IRB “Promptly” is ...
Recommended Practices for Reporting Safety Information
61
(continued) 
• What to report
• Whether to report
• How to repor...
62
KEY
TAKE AWAYS
Key Take Aways
63
• Know where the obligations to report to the IRB originate
• Understand the term “Unanticipated Problem...
• You may submit questions through our webinar
survey
• Mitchell E. Parrish, JD, RAC,CIP
– mparrish@quorumreview.com
– www...
Webinar Follow-Up
• The webinar Recording, Slide Deck,
and Q&A will be posted on our website
• We will email you a link to...
Connect with us!
facebook.com/QuorumReview
@quorumreview youtube.com/quorumreview
linkedin.com/company/quorum‐review
66
Thank You for Attending!
67
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Understanding Reporting Obligations
to the IRB
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Understanding Reporting Obligatins to the IRB

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Reporting 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.

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Understanding Reporting Obligatins to the IRB

  1. 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. 2
  3. 3. 3
  4. 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. 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. 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. 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. 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. 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. 10. Understanding Reporting Obligations To the IRB Today’s Webinar:
  11. 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. 12. Role IRB of The the 12
  13. 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 IRBs—Improving Human Subject Protection (January 2009) “ 13
  14. 14. 14
  15. 15. 15
  16. 16. 16 Problems with Reporting
  17. 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 IRBs—Improving Human Subject Protection (January 2009)
  18. 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 IRBs—Improving 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 study—often with limited information no explanation of how the event represents an unanticipated problem—has led to the submission of large numbers of reports to IRBs that are uninformative.”
  19. 19. 19 Regulatory The Landscape
  20. 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. 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. 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. 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. 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. 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 subject’s 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. 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. 27 Obligations for Reporting Safety Information to the IRB
  28. 28. Regulatory Landscape Unanticipated Problems and Adverse Events 28 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.
  29. 29. Reporting Safety Information to the IRB 29 SUSAR: SERIOUS & UNEXPECTED SUSPECTED ADVERSE REACTIONS UP: UNANTICIPATED PROBLEM UADE: UNANTICIPATED ADVERSE DEVICE EFFECT By its very nature, if an event is an SUSAR or a UADE then it is a UP and must be reported to the IRB
  30. 30. Reporting Safety Information - SUSAR Serious and unexpected suspected adverse reaction (SUSAR) originates from 21 CFR 312 and is designed to guide sponsors on when to submit IND safety reports to the FDA and investigators 30 1. Serious (Death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity, substantial disruption of the ability to conduct normal life functions, and congenital anomaly/birth defect) 2. Unexpected (an event not listed in the investigator brochure or not listed at the specificity or severity observed; or an event not consistent with the risk information described in the investigational plan) 3. Suspected Adverse Reaction (“a reasonable possibility that the drug caused the adverse event”) Evidence to suggest a causal relationship between the drug and event Must report to the IRB all SUSARs that satisfy these three criteria:
  31. 31. Reporting Safety Information - SUSAR Individual Occurrences A single occurrence of an event that is uncommon and known to be strongly associated with drug exposure (e.g., angioedema, hepatic injury, Stevens-Johnson Syndrome) 31
  32. 32. Reporting Safety Information - SUSAR 32 In a phase II study testing an investigational drug for Hepatitis C, a subject experiences hepatic injury. In addition to the investigational drug, the subject was continuing her standard Hepatitis C therapy at the time of hepatic injury. Is this individual occurrence a suspected adverse reaction? Example:
  33. 33. Reporting Safety Information - SUSAR In a phase II study testing an investigational drug for Hepatitis C, a subject experiences hepatic injury. In addition to the investigational drug, the subject was continuing her standard Hepatitis C therapy at the time of hepatic injury. 33 Is this individual occurrence a suspected adverse reaction? Example: YES
  34. 34. Reporting Safety Information - SUSAR 34 One or more Occurrences One or more occurrences of an event that is not commonly associated with drug exposure, but is otherwise uncommon in the population exposed to the drug (e.g., tendon rupture, progressive multifocal leukoencephalopathy)
  35. 35. Reporting Safety Information - SUSAR 35 Is this one occurrence a suspected adverse reaction? Example: A subject with extrapulmonary small-cell carcinoma receiving an investigational chemotherapy agent experiences a bowel perforation during his second cycle of chemotherapy.
  36. 36. Reporting Safety Information - SUSAR 36 Is this one occurrence a suspected adverse reaction? Example: A subject with extrapulmonary small-cell carcinoma receiving an investigational chemotherapy agent experiences a bowel perforation during his second cycle of chemotherapy. NO
  37. 37. Reporting Safety Information - SUSAR 37 Aggregate Analysis of Specific Events An aggregate analysis of specific events observed in a clinical trial (such as known consequences of the underlying disease or condition under investigation or other events that commonly occur in the study population independent of drug therapy) that indicates those events occur more frequently in the drug treatment group than in a concurrent or historical control group.
  38. 38. Reporting Safety Information - SUSAR 17 oncology sites are participating in a research study comparing an investigational chemotherapy agent to standard therapy in subjects ages 60-85. Of those subjects receiving the investigational drug, an average of 35% of subjects across the 17 sites experience deep vein thrombosis. 38 Example: Does this aggregate analysis indicate a suspected adverse reaction?
  39. 39. Reporting Safety Information - SUSAR 17 oncology sites are participating in a research study comparing an investigational chemotherapy agent to standard therapy in subjects ages 60-85. Of those subjects receiving the investigational drug, an average of 35% of subjects across the 17 sites experience deep vein thrombosis. 39 Example: Does this aggregate analysis indicate a suspected adverse reaction? YES
  40. 40. Reporting Safety Information - SUSAR Critical to understand the definition of “Suspected Adverse Reaction” coupled with the examples the FDA provides: 40  Individual occurrence  One or more occurrences  Aggregate analysis
  41. 41. Reporting Safety Information - SUSAR Without this understanding, the FDA explains that the following problem occurs: Reporting of individual events even though unlikely that the event was caused by the drug. Examples: 41 Serious adverse experiences (e.g. mortality or major  morbidity) that are unlikely to have been  manifestations of the underlying disease Serious adverse experiences that commonly  occurred in the study population independent of  drug exposure (e.g. strokes or acute myocardial  infarction in an elderly population) Serious adverse experiences that were study  endpoints (i.e. the study was evaluating whether the  drug reduced the rate of these events) Such reporting causes a “drain on resources” when the FDA, and IRBs are inundated with “generally uninformative” Safety Information especially when reported as single events without any context
  42. 42. Reporting Safety Information - UADE 42 Unanticipated Adverse Device Effect (UADE) originates from 21 CFR 812 and is designed to guide sponsors on when to submit reports to the FDA and investigators Must report to the IRB all UADEs that satisfy the following criteria:  Serious (death, life-threatening, serious problem)  Not previously identified (an effect not previously identified in nature, severity, or degree of incidence in the investigational plan or application)  Caused by, or associated with, a device
  43. 43. Reporting Safety Information - UADE FDA Guidance for Clinical Investigators, Sponsors, and IRBs, Adverse Event Reporting to IRBs—Improving Human Subject Protection (January 2009) 43  Individual occurrence  One or more occurrences  Multiple occurrences determined through an aggregate analysis Essentially states that reporting UADEs to the IRB should be treated the same as reporting SUSARs to the IRB While not in the device regulations and while there are different considerations between safety information for drugs and devices, take into account whether the effect is a:
  44. 44. Recommended Practices for Reporting Safety Information For Multi-center studies: 44 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)  Even though the FDA regulations indicate it is the investigator’s responsibility to notify the IRB of unanticipated problems (21 CFR 312.66)—FDA guidance states: “Investigators must rely on the sponsor to provide them information about AEs occurring at other study sites”  “Although the investigator’s view of the causal relationship between an adverse event and the investigational drug is important, FDA believes that the sponsor is better positioned than the individual investigator to assess the overall safety of the investigational drug because the sponsor has access to serious adverse event reports from multiple study sites and is able to aggregate and analyze these reports.”  “The sponsor is in a better position to process and analyze the significance of AE information from multiple sites…and to make a determination about whether an AE is an unanticipated problem”  FDA supports an arrangement in which the sponsor prepares UP reports and submits to the IRB “when the sponsor, investigator, and IRB have made an explicit agreement for the sponsor to report directly to the IRB”
  45. 45. Recommended Practices for Reporting Safety Information  While Investigators may report SUSARs and UADEs to the IRB, Quorum recommends that Sponsors/CROs submit SUSAR and UADE information to the IRB on behalf of investigators. This means . . . 45 (continued)  • The Sponsor/CRO should inform investigators and arrange with the IRB that it will report on behalf of investigators (arrangement with IRB should include in what format to report) • The protocol should not state generally that “all adverse events require reporting the IRB” or include similar language because then if “all adverse events” are subsequently not reported, investigators run the risk of being out of compliance with the protocol  Also it is not appropriate to submit all AEs to the IRB, just AEs that are SUSARs or UADEs!
  46. 46. Recommended Practices for Reporting Safety Information For single-center or investigator initiated studies: 46  The investigator is likely the one reporting to the IRB  Also it is not appropriate to submit all AEs to the IRB, just AEs that are SUSARs or UADEs! This still means:  The investigator can arrange with IRB in what format to report  The protocol should still not state generally that “all adverse events require reporting the IRB” or include similar language because then if “all adverse events” are subsequently not reported, investigators run the risk of being out of compliance with the protocol
  47. 47. Recommended Practices for Reporting Safety Information 47 (continued)  Report SUSARs and UADEs “promptly” to the IRB “Promptly” is generally considered 10 business days, which is supported in the FDA’s guidance on reporting AEs to the IRB This 10-day timeframe exists whether there is an arrangement for the sponsor to submit on behalf of the IRB or whether the investigator is responsible for submitting to the IRB TIMING of Reporting to the IRB
  48. 48. Recommended Practices for Reporting Safety Information 48 (continued)  • What to report • Whether to report • How to report • When to report QUESTIONS ABOUT: CONTACT the
  49. 49. 49 Obligations for Reporting Non-Safety Information to the IRB
  50. 50. Unanticipated Problems and Adverse Events 50 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 Reporting Non-Safety Information to the IRB
  51. 51. 51 Reporting Non-Safety Information to the IRB UNEXPECTED UP: UNANTICIPATED  PROBLEM You MUST report ALL  UP’s to the IRB GREATER RISK OF  HARM RELATED OR POSSIBLY  RELATED
  52. 52. 52 Reporting Non-Safety Information to the IRB • Failure to obtain informed consent • Major protocol deviations (e.g. inclusion/exclusion violation; omitting a study procedure) • Study personnel misconduct that adversely impacts the study • Adverse findings by a regulatory agency, medical board, or other relevant body Unanticipated Problems - Examples: Are these UPs? * Whether these are UPs depends on the type of study and the specific factors surrounding each event or incident
  53. 53. 53 Reporting Non-Safety Information to the IRB An investigator is conducting behavioral research and collects individually identifiable sensitive information about illicit drug use by surveying college students. The data is stored on a laptop computer that is password protected. The laptop is stolen from the investigator’s car. Is this reportable to the IRB as a UP? Unanticipated Problems - Examples:
  54. 54. 54 Reporting Non-Safety Information to the IRB YES An investigator is conducting behavioral research and collects individually identifiable sensitive information about illicit drug use by surveying college students. The data is stored on a laptop computer that is password protected. The laptop is stolen from the investigator’s car. Is this reportable to the IRB as a UP? Unanticipated Problems - Examples:
  55. 55. An Investigator is conducting a psychology study evaluating decision making and response times when persons are listening to music at various decibel levels. In order to perform the study, participants are placed in a small, windowless, soundproof booth. The IRB-approved protocol and consent form describe claustrophobic reactions as one of the research risks. The 12th subject enrolled in the research experiences significant claustrophobia, resulting in the subject withdrawing from the study. 55 Reporting Non-Safety Information to the IRB Unanticipated Problems - Examples: Is this reportable to the IRB as a UP?
  56. 56. 56 Reporting Non-Safety Information to the IRB NO An Investigator is conducting a psychology study evaluating decision making and response times when persons are listening to music at various decibel levels. In order to perform the study, participants are placed in a small, windowless, soundproof booth. The IRB-approved protocol and consent form describe claustrophobic reactions as one of the research risks. The 12th subject enrolled in the research experiences significant claustrophobia, resulting in the subject withdrawing from the study. Unanticipated Problems - Examples: Is this reportable to the IRB as a UP?
  57. 57. 57 Reporting Non-Safety Information to the IRB Is this reportable to the IRB as a UP? As a result of a processing error by a pharmacy technician, a subject enrolled in a multi-center clinical trial receives a dose of an experimental agent that is 10-times higher than the dose dictated by the IRB-approved protocol. While the dosing error increased the risk of toxic manifestations of the experimental agent, the subject experienced no detectable harm or adverse effect after an appropriate period of careful observation. Unanticipated Problems - Examples:
  58. 58. 58 Reporting Non-Safety Information to the IRB YES Is this reportable to the IRB as a UP? As a result of a processing error by a pharmacy technician, a subject enrolled in a multi-center clinical trial receives a dose of an experimental agent that is 10-times higher than the dose dictated by the IRB-approved protocol. While the dosing error increased the risk of toxic manifestations of the experimental agent, the subject experienced no detectable harm or adverse effect after an appropriate period of careful observation. Unanticipated Problems - Examples:
  59. 59. Recommended Practices for Reporting Non-Safety Information For multi-center or single-center:  Generally, UPs that are not an adverse event (i.e. non-safety related) are typically site or investigator specific  Therefore, it makes more sense for the investigator, not the sponsor, to report the UP to the IRB  The investigator can arrange with IRB in what format to report 59
  60. 60. Recommended Practices for Reporting Non-Safety Information 60 (continued)  Report UPs “promptly” to the IRB “Promptly” is generally considered 10 business days, which is supported in the FDA’s guidance on reporting to the IRB This 10-day timeframe exists whether there is an arrangement for the sponsor to submit on behalf of the IRB or whether the investigator is responsible for submitting to the IRB TIMING of Reporting to the IRB
  61. 61. Recommended Practices for Reporting Safety Information 61 (continued)  • What to report • Whether to report • How to report • When to report QUESTIONS ABOUT: CONTACT the
  62. 62. 62 KEY TAKE AWAYS
  63. 63. Key Take Aways 63 • Know where the obligations to report to the IRB originate • Understand the term “Unanticipated Problem” (UP) and its three  criteria: Unexpected, Related, Greater Risk of Harm • Understand the terms SUSAR and UADE, know their criteria, and  know that these are UPs that require reporting to the IRB • Understand that there are UPs that are not safety‐related that must  be reported to the IRB • Know how and in what timeframe to report to the IRB • If there are ever any questions relating to reporting to the IRB, talk to  your IRB. The IRB is a resource! 
  64. 64. • You may submit questions through our webinar survey • Mitchell E. Parrish, JD, RAC,CIP – mparrish@quorumreview.com – www.linkedin.com/in/mitchellparrish/ • Quorum Client Relations – ClientRelations@QuorumReview.com • We will do our best to follow-up individually or answer your questions in the Q&A we post on our website QUESTIONS? 64
  65. 65. Webinar Follow-Up • The webinar Recording, Slide Deck, and Q&A will be posted on our website • We will email you a link to view these items as they become available • We value your opinion – please take our SURVEY and provide us with feedback 65
  66. 66. Connect with us! facebook.com/QuorumReview @quorumreview youtube.com/quorumreview linkedin.com/company/quorum‐review 66
  67. 67. Thank You for Attending! 67
  68. 68. fully accredited since 2006 Understanding Reporting Obligations to the IRB
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