Reportable New Information

1. Stanley Estime, MSCI QA/QI Specialist January 17, 2013 Reportable New Information

2. Agenda Why is reporting required? Types of Reportable New Information Creating an RNI Submission in ESTR Post Reporting Reporting Scenarios

3. 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

4. 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

5. 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

6. Report Findings of “Regulatory” Non-compliance • Examples include: • Conducting human research procedures without IRB approval • Failure to obtain informed consent from participants • Improper use of a witness during consent process • Investigator not maintaining regulatory or participant files • Etc…

7. 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

8. Report Protocol Deviations/Violations WHO is at fault? • Failure to follow protocol due to actions or inactions of investigators, staff, or participants WHAT needs to be reported? • Any deviation from the IRB-approved protocol which places participants at increase risk of harm or requires change to the protocol in order to eliminate an apparent hazard to participants

9. 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 in criminal or civil liability

10. 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

11. Report Participant Complaints • “Significant” complaints which impact a participants: • Rights; • Welfare; • Safety; OR • Willingness to participate

12. 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

13. Reporting Tools Utilize tools to keep track of reporting/ensure proper reporting: Adverse Event Tracking log Protocol Violation/Deviation Tracking log

14. 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: 14

15. RNI Smart Form • The RNI Smart Form captures the following information: • 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 15

16. 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 be separately submitted through the system and is not done in conjunction with RNI • Question 5: Users will only be able to link to studies for which they are affiliated with • Question 6: Attachments are only used as reference/supporting documents and cannot be “approved” as part of RNI submission. Documents should be attached to Smart Form section via Initial, Continuing, or Modification submission. 16

17. Post Reporting: RNI Notification Notification of Acknowledgement This report of new information has been acknowledged. No further action is required.

18. Reporting Scenarios? During a monitoring visit the following was noticed: • Unsigned copies of consent forms on file • Dates missing from consent documents • Protocol deviations resulting in an adverse event • NTF regarding a missing study laptop which was later recovered by HUPD • Participant enrolled into the incorrect arm of the study but withdrawn after first study visit Which of the following observations would you report to the IRB as an RNI?

19. When in Doubt? Quality Improvement Program Staff • Stanley Estime, sestime@hsph.harvard.edu, 617-432-2164 • Alyssa Speier, aspeier@hsph.harvard.edu, 617-432-2140 • Leslie Howes, lhowes@hsph.harvard.edu, 617-432-2153 IRB Operations Staff • Paul Hryvniak, phryvnia@hsph.harvard.edu, 617-432-2160 • Cecelia Grano De Oro, bgranode@hsph.harvard.edu, 617-432-2142 • Susan Burnside, burnside@hsph.harvard.edu, 617-432-2143 • Julie Kaberry, jkaberry@hsph.harvard.edu, 617-432-2149