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

  • Considerations when communicating

  • Written report

  • Communicating your findings


From investigators to institutional officials strategies for communicating effectively

Lots of observations

Considerations when communicating


From investigators to institutional officials strategies for communicating effectively

vs.


From investigators to institutional officials strategies for communicating effectively

To whom do you communicate?

  • Investigator/study team

  • IRB committee/leadership

  • Institutional leadership


From investigators to institutional officials strategies for communicating effectively

Why do you communicate?

  • You made observations

    And….

  • Want the investigator/study team to take action

  • Collaborate for systematic improvements

  • Alert Institutional leadership


From investigators to institutional officials strategies for communicating effectively

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

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


From investigators to institutional officials strategies for communicating effectively

How do you communicate - 2

Detailed Observations

Aggregate Information

Purpose of communication

  • Investigator / staff

  • IRB committees/ leadership

Audience &

  • Institutional leadership


From investigators to institutional officials strategies for communicating effectively

Why, what, & how…in more detail


Investigators study teams

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

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

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)


From investigators to institutional officials strategies for communicating effectively

  • 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?


From investigators to institutional officials strategies for communicating effectively

The written report


The written report contents

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

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

Example Observation Index


Observation index vs report

Observation Index vs. Report

Provide details regarding the observation in the report


Maintain a database

Maintain a Database

Study Visit Details

Observations & Corrective Actions

Program Output


From investigators to institutional officials strategies for communicating effectively

Communicating your findings


Case studies

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

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

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

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

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

    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

    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 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

    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 – Activity trending


    Example onsite review audit conclusions

    Example – Onsite review/audit conclusions


    Example most frequent observations for irb

    Example – Most Frequent Observations (for IRB)


    Example most frequent observations for institutional leadership

    Example – Most Frequent Observations (for institutional leadership)

    *Be prepared to track systematic improvements


    Example investigators of concern

    Example –Investigators of concern


    From investigators to institutional officials strategies for communicating effectively

    Thank you!

    &

    Questions?


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