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.

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
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• Responses will be sent by the presenters
following the presentation
4
WEBINAR HOUSEKEEPING

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• The webinar recording and slide deck will be
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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
Today’s 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 IRBs—Improving 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 IRBs—Improving 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 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
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 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. 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 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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
Obligations for
Reporting
Non-Safety
Information
to the IRB

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
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
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
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
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. 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
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
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
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. 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. 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. 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
KEY
TAKE AWAYS

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. • 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. 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

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linkedin.com/company/quorum‐review
66

67. Thank You for Attending!
67

68. fully accredited since 2006
Understanding Reporting Obligations
to the IRB