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

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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]

slide2

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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