From Investigators to Institutional Officials: Strategies for Communicating Effectively

1. From Investigators to Institutional Officials: Strategies for Communicating Effectively Sarah A. White, MPH, CIP Director, Quality Improvement Program Partners Healthcare swhite12@partners.org HSPH QA/QI Boot Camp ● August 22, 2013

2. Outline • Considerations when communicating • Written report • Communicating your findings

3. Lots of observations Considerations when communicating

4. vs.

5. To whom do you communicate? • Investigator/study team • IRB committee/leadership • Institutional leadership

6. Why do you communicate? • You made observations And…. • Want the investigator/study team to take action • Collaborate for systematic improvements • Alert Institutional leadership

7. What are you communicating? • Observations of noncompliance • Suggested corrective actions • Systematic improvements • Results of an onsite review/audit…what about your opinion??

8. How do you communicate? • Detailed vs. aggregate, depends on the: • Audience • Purpose • Verbal • One-on-one with Investigator/study team • Presentations • Written • Onsite review/audit report • Metrics report

9. How do you communicate - 2 Detailed Observations Aggregate Information Purpose of communication • Investigator / staff • IRB committees/ leadership Audience & • Institutional leadership

10. Why, what, & how…in more detail

11. Investigators/Study Teams • Purpose: • Communicate details of recent audit • Self-directed quality improvement • How: • One-on-one: in person, via telephone • Specific observations, references, corrective actions • Written, detailed report • When: • Immediately after audit (ideally 1 week)

12. IRB Committee/Leadership • Purpose • Communicate details of recent IRB requested audit • Communicate noncompliance • Identify gaps in institutional policies & forms • Systematic improvements • How • Detailed information – written report • Detailed information about major noncompliance and follow up • Aggregate metrics • Historical/comparative analyses and trending • When • IRB requested audits/Noncompliance – immediately • Metrics – twice per year

13. Institutional leadership • Purpose • Communicate details of institutional requested audit • Provide pulse on noncompliance activity • Major and ‘under their radar’ • Inform about follow-up • Inform about systemic improvements • Gain support for program activities • How • Detailed information about ‘Investigators of concern’ • Comparative analyses and historical trending • Frequent observations • Timing • Institutional requested audit - immediately • Metrics – routinely (twice per year)

14. Observations of noncompliance – when do you alert others? • Do you have an obligation to inform • ‘higher ups’ of observations of noncompliance? • All or some noncompliance? • Do you have a process? • Do external inspectors/auditors see your • written reports?

15. The written report

16. The written report - contents Report should contain: • Introduction • Observation(s) • Regulatory reference • Corrective action • Alternately request site determine corrective action • Conclusion • Priorities

17. The written report - Observations • Create a standard observation index • Allows program to be consistent • Categorized by Topic (e.g. Regulatory documentation, Subject documentation, Informed consent process) • Regulatory citations and recommended corrective actions linked to specific observations • Use federal regulations, institutional policies, GCP • Accommodate drug/device verses non drug/device studies • Allow flexibility • New observations/corrective actions can be approved by manager or by team consensus

18. Example Observation Index

19. Observation Index vs. Report Provide details regarding the observation in the report

20. Maintain a Database Study Visit Details Observations & Corrective Actions Program Output

21. Communicating your findings

22. Case studies Before we begin…. • Factors that effect communication: • The particular observation • The audience • The situation • Who are your ‘backups’?

23. Case #1: Investigator doesn’t know requirements • Clinical Investigator for an industry sponsored, multicenter study device trial • This is the only clinical trial the Investigator has participated in • IRB suspects noncompliance and asks you to conduct an onsite review • When onsite, the PI provides all the documentation and says ‘I tried my best’…

24. Case #1: Investigator doesn’t know requirements - 2 • Your findings include: • Approved protocol include 1, 3, and 5 yr f/u with subjects. For all 6 subjects, only 1 year f/u conducted. In some cases, PI is no longer subject’s clinician • A consent form is not on file for 1 subject. Review of clinical notes do not indicate the PI told subject she was part of research study. • Office manager obtained consent for 2 of 4 subjects. • Implant occurred prior to documentation of consent

25. Case #2: Investigator can’t be bothered • Clinical Investigator-initiated trial looking at the timing of a routine post-op treatment • This is the only clinical trial the Investigator has participated in • IRB suspects noncompliance and asks you to conduct an onsite review • When you call the PI to schedule the review he yells at you and says ‘I don’t have time for this!’….

26. Case #2: Investigator can’t be bothered - 2 • PI does not attend; you work with a Co-Investigator • Your findings include: • No study files • Consent for only subject enrolled is at another office • Could not verify eligibility • Approved protocol states tx at 2 weeks, 6 weeks, or 3 months; Subject had tx at 8 months

27. Case #3: Investigator has been hoodwinked • Clinical Investigator in an industry funded, multicenter investigational drug trial • Upcoming Sponsor close out audit; PI asks you to come help prepare • PI obtains consent for all subjects • In reviewing consent forms, you notice that for 5 subjects, the approval date of the consent form is after the date the PI/subject signed consent • When you inquire with PI, he says ‘that’s not my signature’

28. Case #4: Investigator trying to do the right thing • Clinical Investigator-initiated trial looking at tactile stimulation • Self-requests to have an onsite review • Study procedures include acupuncture by an ‘experienced acupuncturist’ • PI is not an acupuncturist however conducted all the acupuncture • After you recognize this finding, PI will immediately get an acupuncturist but does not want to report to IRB

29. QI of the IRB • QI & IRB collaboration is essential in any HRPP • Document the scope and process • Make sure IRB is receptive to QI efforts and information given to them • Provide corrective action or collaborate to systematically improve

30. Metric reports – aggregate data • Purpose: • Identify problem areas • Are you consistently providing follow up when needed? • Leads to development of systematic improvements • Examples • Grouping of site observations by: areas of deficiencies, departments, sponsor, review type • Areas or investigators of concern • Comparative analyses and historical trending • Best practices • Timing • Quarterly, annually

31. Example – Activity trending

32. Example – Onsite review/audit conclusions

33. Example – Most Frequent Observations (for IRB)

34. Example – Most Frequent Observations (for institutional leadership) *Be prepared to track systematic improvements

35. Example –Investigators of concern

36. Thank you! & Questions?