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 [email protected] 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

From Investigators to Institutional Officials: Strategies for Communicating Effectively

Sarah A. White, MPH, CIP

Director, Quality Improvement Program

Partners Healthcare

[email protected]

HSPH QA/QI Boot Camp ● August 22, 2013


Outline
Outline for Communicating Effectively

  • Considerations when communicating

  • Written report

  • Communicating your findings


Lots of observations for Communicating Effectively

Considerations when communicating


vs. for Communicating Effectively


To whom do you communicate? for Communicating Effectively

  • Investigator/study team

  • IRB committee/leadership

  • Institutional leadership


Why do you communicate? for Communicating Effectively

  • You made observations

    And….

  • Want the investigator/study team to take action

  • Collaborate for systematic improvements

  • Alert Institutional leadership


What are you communicating? for Communicating Effectively

  • Observations of noncompliance

  • Suggested corrective actions

  • Systematic improvements

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


How do you communicate
How do you communicate? for Communicating Effectively

  • 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 for Communicating Effectively

Detailed Observations

Aggregate Information

Purpose of communication

  • Investigator / staff

  • IRB committees/ leadership

Audience &

  • Institutional leadership


Why, what, & how…in more detail for Communicating Effectively


Investigators study teams
Investigators/Study Teams for Communicating Effectively

  • 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
IRB Committee/Leadership for Communicating Effectively

  • 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
Institutional leadership for Communicating Effectively

  • 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)


  • 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 for Communicating Effectively


The written report contents
The written report - contents for Communicating Effectively

Report should contain:

  • Introduction

  • Observation(s)

    • Regulatory reference

  • Corrective action

    • Alternately request site determine corrective action

  • Conclusion

    • Priorities


The written report observations
The written report - Observations for Communicating Effectively

  • 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
Example Observation for Communicating EffectivelyIndex


Observation index vs report
Observation Index vs. Report for Communicating Effectively

Provide details regarding the observation in the report


Maintain a database
Maintain a Database for Communicating Effectively

Study Visit Details

Observations & Corrective Actions

Program Output


Communicating your findings for Communicating Effectively


Case studies
Case studies for Communicating Effectively

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
Case #1: Investigator doesn’t know requirements for Communicating Effectively

  • 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
Case #1: Investigator doesn’t know requirements - 2 for Communicating Effectively

  • 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
Case #2: Investigator can’t be bothered for Communicating Effectively

  • 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
Case #2: Investigator can’t be bothered - 2 for Communicating Effectively

  • 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
    Case #3: Investigator has been hoodwinked for Communicating Effectively

    • 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
    Case #4: Investigator trying to do the right thing for Communicating Effectively

    • 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 of the IRB for Communicating Effectively

    • 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
    Metric reports – aggregate data for Communicating Effectively

    • 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 – Activity trending for Communicating Effectively


    Example onsite review audit conclusions
    Example – Onsite review/audit conclusions for Communicating Effectively



    Example most frequent observations for institutional leadership
    Example – Most Frequent Observations (for institutional leadership)

    *Be prepared to track systematic improvements



    Thank you! leadership)

    &

    Questions?


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