From investigators to institutional officials strategies for communicating effectively
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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

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From Investigators to Institutional Officials: Strategies for Communicating Effectively

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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

  • Written report

  • Communicating your findings


Lots of observations

Considerations when communicating


vs.


To whom do you communicate?

  • Investigator/study team

  • IRB committee/leadership

  • Institutional leadership


Why do you communicate?

  • You made observations

    And….

  • Want the investigator/study team to take action

  • Collaborate for systematic improvements

  • Alert Institutional leadership


What are you communicating?

  • Observations of noncompliance

  • Suggested corrective actions

  • Systematic improvements

  • Results of an onsite review/audit…what about your opinion??


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


How do you communicate - 2

Detailed Observations

Aggregate Information

Purpose of communication

  • Investigator / staff

  • IRB committees/ leadership

Audience &

  • Institutional leadership


Why, what, & how…in more detail


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)


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


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)


  • 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?


The written report


The written report - contents

Report should contain:

  • Introduction

  • Observation(s)

    • Regulatory reference

  • Corrective action

    • Alternately request site determine corrective action

  • Conclusion

    • Priorities


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


Example Observation Index


Observation Index vs. Report

Provide details regarding the observation in the report


Maintain a Database

Study Visit Details

Observations & Corrective Actions

Program Output


Communicating your findings


Case studies

Before we begin….

  • Factors that effect communication:

    • The particular observation

    • The audience

    • The situation

  • Who are your ‘backups’?


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’…


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


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!’….


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


  • 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’


    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


    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


    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


    Example – Activity trending


    Example – Onsite review/audit conclusions


    Example – Most Frequent Observations (for IRB)


    Example – Most Frequent Observations (for institutional leadership)

    *Be prepared to track systematic improvements


    Example –Investigators of concern


    Thank you!

    &

    Questions?


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