Stanley Estime, MSCI
QA/QI Specialist
January 17, 2013
Reportable New Information
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Agenda
Why is reporting required?
Types of Reportable New Information
Creating an RNI Submission in ESTR
Post Reporting
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 anyunanticipated problems or serious continuingnoncompliance.
21 CFR 56.108(b)(1) and 45 CFR 46.103(b)(5)
New information becomes available during study whichmay require IRB/Investigator to reassess the risk/benefitto participants
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Reportable “New” Information
Change in Risk/Benefits
Adverse Events
Findings/Allegations of Regulatory Non-Compliance
Audits/Inspections by Federal Agency
Protocol Deviations/Violations
Breach of Confidentiality
Incarceration of 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 arenot reflected in the IRB-approved protocol/consent form.
*A harm is possibly related when the research proceduresmore likely than not caused the harm
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Report Findings of “Regulatory”Non-compliance
Examples include:
Conducting human research procedures without IRBapproval
Failure to obtain informed consent from participants
Improper use of a witness during consent process
Investigator not maintaining regulatory or participant files
Etc…
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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 maypotentially result in an audit
Post Audit Notification IRB
–(i.e. suspension/termination of research bysponsor
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Report Protocol Deviations/Violations
WHO is at fault?
Failure to follow protocol due to actions or inactionsof investigators, staff, or participants
WHAT needs to be reported?
Any deviation from the IRB-approved protocol whichplaces participants at increase risk of harm orrequires change to the protocol in order to eliminatean apparent hazard to participants
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Report Breach of Confidentiality
For example: A stolen laptop containingidentifiable study information or an emailcontaining the names of participantsinadvertently sent to individuals outside theresearch team.
–Breach information may be damaging to participants’ financialstanding, employability, reputation or place participant in criminalor civil liability
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Report Incarcerations
Any participant who is incarcerated duringthe course of the study for a protocol whichhas not been previously approved to enrollprisoners
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Report Participant Complaints
“Significant” complaints which impact aparticipants:
–Rights;
–Welfare;
–Safety; OR
–Willingness to participate
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Reporting Time Frame
Within 5 business days from the time thestudy team became aware of the information
Ensure knowledge of Sponsor’s and/or FDAreporting requirements when applicable
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Reporting Tools
Utilize tools to keep track of reporting/ensureproper reporting:
–Adverse Event Tracking log
–Protocol Violation/Deviation Tracking log
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 Smart Form
The RNI Smart Form captures the followinginformation:
–Date PI became aware of the information
–Categories of the new information (New Risk,Harm, Audit, Researcher Error, Complaint, etc.)
–Description of the information
–If the new information:
Poses a change to the study risk(s)
Requires a modification to the approved research
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RNI Smart Form Tips
Question 3: Enter Protocol # as part of description of new information
Question 4b: If revisions are required, modification still needs to beseparately submitted through the system and is not done inconjunction with RNI
Question 5: Users will only be able to link to studies for which they areaffiliated with
Question 6: Attachments are only used as reference/supportingdocuments and cannot be “approved” as part of RNI submission.Documents should be attached to Smart Form section via Initial,Continuing, or Modification submission.
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Post Reporting: RNI Notification
To:
Stanley Estime
Subject:
Reportable new information acknowledged
Study Link:
Study Title:
New Information 12/12/2012 9:59 AM
PrincipalInvestigator:
Stanley Estime
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Notification of Acknowledgement
This report of new information has been acknowledged. No further action is required.
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Reporting Scenarios?
During a monitoring visit the following was noticed:
1.Unsigned copies of consent forms on file
2.Dates missing from consent documents
3.Protocol deviations resulting in an adverse event
4.NTF regarding a missing study laptop which was laterrecovered by HUPD
5.Participant enrolled into the incorrect arm of the studybut withdrawn after first study visit
Which of the following observations would you report to the IRB asan RNI?
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When in Doubt?
Quality Improvement Program Staff
IRB Operations Staff