from investigators to institutional officials strategies for communicating effectively
Download
Skip this Video
Download Presentation
From Investigators to Institutional Officials: Strategies for Communicating Effectively

Loading in 2 Seconds...

play fullscreen
1 / 36

From Investigators to Institutional Officials: Strategies for Communicating Effectively - PowerPoint PPT Presentation


  • 162 Views
  • Uploaded on

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

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about ' From Investigators to Institutional Officials: Strategies for Communicating Effectively' - bambi


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.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
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
slide3

Lots of observations

Considerations when communicating

slide5

To whom do you communicate?

  • Investigator/study team
  • IRB committee/leadership
  • Institutional leadership
slide6

Why do you communicate?

  • You made observations

And….

  • Want the investigator/study team to take action
  • Collaborate for systematic improvements
  • Alert Institutional leadership
slide7

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
slide9

How do you communicate - 2

Detailed Observations

Aggregate Information

Purpose of communication

  • Investigator / staff
  • IRB committees/ leadership

Audience &

  • Institutional leadership
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)
slide14

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 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
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

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

*Be prepared to track systematic improvements

slide36

Thank you!

&

Questions?

ad