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Stanley Estime, MSCI QA/QI Specialist February 12, 2014. Looking at the Man in the Mirror: What to Do When You Find Non-Compliance?. Agenda. Why is reporting required? Types of Reportable New Information Top Ten Investigator Common Deficiencies Creating an RNI Submission in ESTR - PowerPoint PPT Presentation
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Stanley Estime, MSCI
QA/QI Specialist
February 12, 2014
Looking at the Man in the Mirror: What to Do When You Find Non-Compliance?
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Agenda
Why is reporting required? Types of Reportable New Information Top Ten Investigator Common Deficiencies Creating an RNI Submission in ESTR Post Reporting: What’s Next? Reporting Scenarios
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Why is reporting required?
DHHS and FDA regulations require that IRBs have:
Written procedures for ensuring prompt reporting of any unanticipated problems or serious continuing noncompliance.
21 CFR 56.108(b)(1) and 45 CFR 46.103(b)(5)
New information becomes available during study which may require IRB/Investigator to reassess the risk/benefit to participants
Last but not least to avoid continuous non-compliance
To Report or Not to Report?
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Common Findings QA/QI Assistance“The PI is unfamiliar with regulatory requirements and/or institutional policy...”
• Reporting to IRB/Sponsor/FDA• Drafting/Implementing Corrective
Action Plan• Provide Study Management
Tools in order to track and avoid future non-compliance
• Provide federal and institutional guidance/requirements pertaining to finding
• Provide external audit prep
Possible Root Causes
• Misinterpretation; don’t understand
• Don’t know where to find information
• Fears potential consequences• Don’t believe it’s a “big deal”
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Reportable “New” Information
Change in Risks/Benefits Adverse Events (Internal and External) Findings/Allegations of Regulatory Non-Compliance Audits/Inspections by Federal Agency Protocol Deviations/Violations Breach of Confidentiality Incarceration of Enrolled Participants Participant Complaints Protocol Suspension/Termination
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Reporting Adverse Events
Useful to maintain an Adverse Event Tracking log:– Date of Event– Description– Severity– Expectedness*– Relatedness*– Date Reported to the IRB, Sponsor or FDA
*A harm is unexpected when its specificity and severity are not reflected in the IRB-approved protocol/consent form.
*A harm is possibly related when the research procedures more likely than not caused the harm
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Report Findings of “Regulatory” Non-compliance
Examples include: Conducting human research procedures without IRB
approval Failure to obtain/document informed consent from
participants Improper use of a witness during consent process Investigator not maintaining regulatory or participant
files
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Report Audit Inspection
Report any audits by federal agencies:– FDA, OHRP, DOD, VA
Pre-Audit Notification Recommend QIP- Also notify QIP/IRB of any sponsor inquiries which may potentially result in an audit
Post Audit Notification IRB– i.e. suspension/termination of research by sponsor
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Report Protocol Deviations/Violations
WHO is at fault? Failure to follow protocol due to actions or inactions
of investigators, staff, or participants participants
WHAT needs to be reported? Any deviation from the IRB-approved protocol which
places participants at increased risk of harm or requires change to the protocol in order to eliminate an apparent hazard to participants
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Report Breach of Confidentiality
For example: A stolen laptop containing identifiable study information or an email containing the names of participants inadvertently sent to individuals outside the research team.– Breach information may be damaging to
participants’ financial standing, employability, reputation or place participant at criminal or civil liability
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Report Incarcerations
Any participant who is incarcerated during the course of the study for a protocol which has not been previously approved to enroll prisoners
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Report Participant Complaints
“Significant” complaints by participants that the PI cannot resolve:
– Rights;– Welfare;– Safety; OR– Willingness to participate
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Protocol Suspension/Termination
Any premature suspension or termination of the research by the sponsor, investigator, or institution
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OHRA Reporting Time Frame
Within 5 business days from the time the study team became aware of the information
Ensure knowledge of Sponsor’s and/or FDA reporting requirements when applicable
Top Ten Investigator Common Deficiencies Identified through QIP Onsite Reviews & For Cause Audits
1. Inadequate knowledge of regulatory requirements/institutional policies
2. Failure to follow IRB-approved protocol3. Failure to report protocol violations4. Failure to report adverse events & UAPs5. Improper documentation of informed consent6. Failure to document subject eligibility7. Incomplete/inaccurate source documentation 8. Poor/insufficient record keeping9. Lack of IRB approval10. Lack of study monitoring15
Creating an RNI Submission in ESTR
An RNI (Reportable New Information) submission can be created:– From the personal workspace for RNIs NOT associated with a particular study– From the approved study workspace for RNIs related to that specific study
Study Workspace:Personal Workspace:
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RNI Form in ESTR
The RNI Form captures the following information:– Date PI became aware of the information– Category of the new information (New or increased
risk or unexpected and possibly related harm)– Description of the information– If the new information in the PI’s opinion:
Poses a change to the study risk(s) Requires a modification to the approved research
Note: If new information is associated with more than one study a separate report should be created for each
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Tips for Completing RNI Form
Enter Protocol # as part of description of new information as well as indicate the corrective action plan by the study team (Question 3)
Users will only be able to link to studies for which they are already affiliated (Question 5).
Attachments on RNI workspace are only used as reference/supporting documents and will not be “approved” as part of RNI submission. Any documents requiring IRB approval should be attached to appropriate ESTR section via Initial, Continuing, or Modification submission (Question 6)
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IRB Actions - Post Reporting
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Post Reporting: RNI Notification
To: Stanley Estime
Subject: Reportable new information acknowledged
Study Link: New Reportable Information 12/12/2012 9:59 AM
Study Title: New Reportable Information 12/12/2012 9:59 AM
Principal
Investigator:
Stanley Estime
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Notification of AcknowledgementThis report of new information has been acknowledged. No further action is required.
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Reporting Tools
Utilize tools to keep track of reporting/ensure proper reporting:
– Adverse Event Tracking log– Protocol Violation/Deviation Tracking log
http://www.hsph.harvard.edu/ohra/qip/study-management-tools/
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Reporting Scenario?
During a monitoring visit the following observations were discovered:
1. Unsigned copies of participant consent forms2. Dates missing from executed consent documents3. Protocol deviations 4. A note-to-file regarding a missing study laptop which was later recovered by HUPD5. Case report forms on file for a participant enrolled into the incorrect arm of the study. He withdrew after his first study visit as a result of complaints of headaches possibly associated with study medication.
Which of the following observations would you report to the IRB as an RNI?
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When in Doubt?
Quality Improvement Program Staff Stanley Estime, [email protected], 617-432-2164 Lisa Gabel, [email protected], 617-432-5842 Leslie Howes, [email protected], 617-432-2153
IRB Operations Staff Department Assigned IRB Review Specialist:
http://www.hsph.harvard.edu/ohra/department-assignments/
IRB Administrative ChairJulie Kaberry, [email protected], 617-432-2149