1 / 36

From Investigators to Institutional Officials: Strategies for Communicating Effectively

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. Outline. Considerations when communicating

bambi
Download Presentation

From Investigators to Institutional Officials: Strategies for Communicating Effectively

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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?

More Related