Independent qa qi program an indispensable entity of a human research protection program
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Independent QA/QI Program: An Indispensable Entity of a Human Research Protection Program . Delia Wolf, M.D. Director, Partners Quality Improvement and Human Subjects Protection Program Partners HealthCare System E-mail; [email protected] Vice President, Partners Research Management.

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Independent qa qi program an indispensable entity of a human research protection program

Independent QA/QI Program: An Indispensable Entity of aHuman Research Protection Program

Delia Wolf, M.D.

Director, Partners Quality Improvement and Human Subjects Protection Program

Partners HealthCare System

E-mail; [email protected]


Vice President,

Partners Research Management

Director,

Human Research Affairs

G.C.O.

Director,

QI Program

Director, IRBs

PCAC

Investigator

QA/QI

IRB

QA/QI

Education


General goals
General Goals

  • Create an institutional culture that embraces the principle of responsible research review and conduct

  • Establish a process of continuous review and oversight of all human research activities


Specific goals
Specific Goals

  • Ensure investigator compliance and improve study site performance

  • Assess IRB review and approval process

  • Facilitate communication between investigator and IRB

  • Improve existing and recommend new policies and procedures


Qa qi program activities
QA/QI Program Activities

  • Conduct routine QI on-site review

  • Assist investigator to conduct self-assessment

  • Provide consultation to study site

  • Assist study site in preparation for an external audit

  • Review IRB files and evaluate IRB review process


Qa qi program activities1
QA/QI Program Activities

  • Provide IRB with feedback from study site

  • Conduct inspections and investigations in response to inquiries or complaints received from IRBs, regulatory agencies, sponsors or research participants

  • Make recommendations to institution official (e.g. draft policies and procedures)


Ensuring study site compliance and improving performance
Ensuring Study Site Compliance and Improving Performance

  • Informed consent process

  • Record keeping

  • Continuing review application

  • Corrective actions

  • Quality Improvement tips (developing user friendly tools)


Assessing irb review approval process
Assessing IRBReview/Approval Process

  • Policy enforcement

    • AE reporting

    • Deviation/violation reporting

    • Study lapse

    • Continuing review submission

  • Database accuracy

  • Record keeping

  • Corrective actions


Facilitating communication
Facilitating Communication

  • Inform investigators about current institutional policies and procedures

  • Make investigators aware of submission requirements for initial and continuing review

  • Present common IRB-related findings from study site to the IRB chairs, administrators, and protocol administrators

  • Serve as a “middle person”


Improving written p p
Improving Written P & P

  • Revise existing policies/procedures and guidance documents

    • AE reporting guidelines

    • Continuing review submission deadlines

    • Violation/deviation reporting guidelines

    • IRB initial/continuing review forms

  • Providing template with instructions

    • Protocol

    • Protocol summary

    • Consent form


Key elements for a successful qa qi program
Key Elements for a Successful QA/QI Program

  • Institutional support

  • Experienced, knowledgeable, and enthusiastic staff

  • Collaboration rather than confrontation

  • Be responsive and flexible

  • Be tough

  • Be fair


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