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    Intro To Bioresearch Monitoring Apr 22 - Cooper PDF

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    The Bioresearch Monitoring Program (BIMO) aims to protect human subjects and ensure reliable clinical trial data. BIMO inspects sponsors, clinical investigators, IRBs, and laboratories. Key roles include sponsors, clinical investigators, monitors, CROs, and IRBs. BIMO has four compliance programs and regulates clinical trials under regulations including 21 CFR Parts 50, 54, 56, 58, 809 and 812. Additional guidance documents are available on the FDA website.

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    Intro To Bioresearch Monitoring Apr 22 - Cooper PDF

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    The Bioresearch Monitoring Program (BIMO) aims to protect human subjects and ensure reliable clinical trial data. BIMO inspects sponsors, clinical investigators, IRBs, and laboratories. Key roles include sponsors, clinical investigators, monitors, CROs, and IRBs. BIMO has four compliance programs and regulates clinical trials under regulations including 21 CFR Parts 50, 54, 56, 58, 809 and 812. Additional guidance documents are available on the FDA website.

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    Intro to Bioresearch Monitoring Apr 22 - Cooper.pdf

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    The Bioresearch Monitoring Program (BIMO) aims to protect human subjects and ensure reliable clinical trial data. BIMO inspects sponsors, clinical investigators, IRBs, and laboratories. Key roles include sponsors, clinical investigators, monitors, CROs, and IRBs. BIMO has four compliance programs and regulates clinical trials under regulations including 21 CFR Parts 50, 54, 56, 58, 809 and 812. Additional guidance documents are available on the FDA website.

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    128 views27 pages

    Intro To Bioresearch Monitoring Apr 22 - Cooper PDF

    Uploaded by

    feawef
    The Bioresearch Monitoring Program (BIMO) aims to protect human subjects and ensure reliable clinical trial data. BIMO inspects sponsors, clinical investigators, IRBs, and laboratories. Key roles include sponsors, clinical investigators, monitors, CROs, and IRBs. BIMO has four compliance programs and regulates clinical trials under regulations including 21 CFR Parts 50, 54, 56, 58, 809 and 812. Additional guidance documents are available on the FDA website.

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    of 27

    Introduction into the

    Bioresearch Monitoring Program


    Presented by Janet H. Cooper, BS MT, MFS
    Consumer Safety Officer
    Division of Bioresearch Monitoring
    Office of Compliance
    Center for Devices and Radiological Health

    Objectives
    z
    z
    z
    z
    z

    Explain the objectives of the FDAs


    Bioresearch Monitoring Program
    Recognize the specific roles involved in
    device clinical trials
    Describe the different compliance programs
    Identify the FDA regulations that apply to
    BIMO
    Understand where to obtain additional
    information

    Presentation Topics
    z Background
    z Program Objectives
    z Program Functions
    z Inspection Programs
    z Applicable Regulations
    z Guidance and Information

    BIMO Program Background


    Known as BIMO
    z 1975-1976 Congressional Hearings
    z Directed FDA to establish an
    agency-wide program
    z Encompass all operational bureaus
    & regulated products
    z Authorized $16M & 606 FTEs

    BIMO Program Background


    A comprehensive, agency-wide
    program of on-site inspections and
    data audits designed to monitor all
    aspects of the conduct and
    reporting of FDA-regulated
    research

    BIMO Program Background


    The BIMO program monitors:
    Sponsors/Contract Research
    Organizations (CROs)/Monitors
    Institutional Review Boards (IRBs)
    Clinical Investigators (CIs)
    Nonclinical Laboratories

    BIMO Program Objectives


    z Protect the rights, safety, and

    welfare of human research subjects


    z Assure the quality, reliability, and
    integrity of data collected

    BIMO Program Functions


    z Audit clinical data
    z Inspect ongoing clinical research
    z Inspect nonclinical laboratories
    z Inspect IRBs
    z Educate and train
    z Implement FDAs Application

    Integrity Policy

    What may Prompt an Inspection


    of Device Research?
    z New Product or Indication
    z New Technology
    z Complaints
    z History of non-compliance
    z Routine Surveillance

    BIMO Inspection Programs


    z Routine

    Surveillance
    Compliance follow-up
    z Directed

    Data audits of device submissions


    z For Cause

    Investigate problems
    Investigate complaints

    BIMO Inspection Programs


    Inspection Classifications
    z NAI No Action Indicated
    z VAI Voluntary Action Indicated
    z OAI Official Action Indicated

    BIMO Compliance Programs


    z Clinical Investigators
    z Sponsors, Contract Research

    Organizations, and Monitors


    z Institutional Review Boards
    z Good Laboratory Practices
    www.fda.gov/ora/cpgm/default.htm#bimo

    Clinical Investigator (CI)


    An individual who actually conducts a
    clinical investigation, under whose
    immediate direction the test article
    is administered, dispensed, or
    used.

    Sponsor
    z Takes responsibility for and initiates

    a clinical investigation, but does not


    actually conduct the investigation
    z May be an individual, company,
    government agency, academic
    institution, private organization

    Monitor
    z Individual designated by a sponsor

    or contract research organization to


    oversee the progress of an
    investigation
    z Must be qualified by training and
    experience to monitor the device
    investigation

    Contract Research Organization (CRO)


    A person who assumes, as an
    independent contractor with the
    sponsor, one or more of the
    obligations of a sponsor

    Institutional Review Board (IRB)


    Any board, committee, or other group
    formally designated by an
    institution to review, to approve the
    initiation of, and conduct periodic
    review of, biomedical research
    involving human subjects

    Sponsor-Investigator (SI)
    An individual who both initiates and
    actually conducts, alone or with
    others, an investigation, and under
    whose immediate direction the
    investigational product is
    administered, dispensed, or used.
    The obligations include both those
    of a sponsor and an investigator

    Non-Clinical Laboratories
    Animal laboratories where preclinical studies are conducted

    FDA Regulations
    that apply to BIMO
    z 21 CFR 50: Protection of Human

    Subjects
    z 21 CFR 54: Financial Disclosure
    z 21 CFR 56: Institutional Review Boards
    (IRB)
    z 21 CFR 58: Good Laboratory Practice
    for Non-Clinical Laboratory Studies
    (GLP)

    FDA Regulations
    that apply to BIMO
    z 21 CFR 809:

    In Vitro Diagnostic
    Products (IVD)
    z 21 CFR 812: Investigational Device
    Exemption (IDE)

    Guidance and Information


    z Computerized Systems Used in

    Clinical Investigations, May 2007


    z Protecting the Rights, Safety, and
    Welfare of Study Subjects
    Supervisory Responsibilities of
    Investigators, May 2007

    Guidance and Information


    z The Review and Inspection of

    Premarket Approval Applications under


    the Bioresearch Monitoring Program,
    January 2008
    z Guidance for Sponsors, Clinical
    Investigators, and IRBs Data
    Retention When Subjects Withdraw
    from FDA-regulated clinical trials,
    October 2008

    Guidance and Information


    z Draft Guidance

    Protecting the Rights, Safety, and Welfare


    of Study Subjects Supervisory
    Responsibilities of Investigators
    z Information Sheets

    Frequently Asked Questions About IRB


    Review of Medical Devices
    Significant and Non-significant Risk
    Medical Device Studies

    For More Information


    z FDA Home Page www.fda.gov
    z Center for Devices and Radiological

    Health www.fda.gov/cdrh/
    z Device Advice
    www.fda.gov/cdrh/devadvice
    z CDRH BIMO site
    www.fda.gov/cdrh/bimo/html

    For More Information


    z FDA Good Clinical Practices

    www.fda.gov/oc/gcp/default.htm
    z Code of Federal Regulations (CFR)
    Main Page
    http://www.accessdata.fda.gov/scripts/c
    drh/cfdocs/cfcfr/cfrsearch.cfmw
    z FDA Consumer Magazine
    www.fda.gov/fdac/

    Summary
    z Objectives of the BIMO program
    z Specific roles in clinical trials
    z Four compliance programs
    z FDA regulations applicable to

    BIMO
    z Additional information

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