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Response to FDA Audit 483 MX-4501N 20100317 114032 3-10 : Nine Category 483 Citations Meetings

FDA Audit Citations – March 2010. Response to FDA Audit 483 MX-4501N 20100317 114032 3-10 : Nine Category 483 Citations Meetings Minutes : Votes for, against, abstention and reason not recorded; controverted [sic: controversial] discussions not summarized

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Response to FDA Audit 483 MX-4501N 20100317 114032 3-10 : Nine Category 483 Citations Meetings

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  1. FDA Audit Citations – March 2010 • Response to FDA Audit 483 MX-4501N 20100317 114032 3-10: • Nine Category 483 Citations • Meetings • Minutes: Votes for, against, abstention and reason not recorded; controverted [sic: controversial] discussions not summarized • Diversity: Meeting convened without a non-scientific member • Teleconferencing Participation: Lack of documentation of materials supplied to teleconferencing member • Interim Convened Meetings: Lack of documentation of provision for and recording of materials provided at Interim convened meetings • Suspension Reporting: A study’s accrual suspension was not reported to the FDA • Membership • Membership rosters: Lack of documentation of scientific vs. non-scientific designation, affiliate vs. non-affiliate and voting status

  2. FDA Audit Citations – March 2010 • Response to FDA Audit 483 MX-4501N 20100317 114032 3-10: • Nine Category 483 Citations (continued) • Investigator Responsibilities • Investigator Compliance: Compliance by Principal Investigator is not prospectively surveyed • Documentation • Electronic Recording and Processing: Electronic method not CFR “part 11” compliant; March-April 2008 files missing • Serious Adverse Events: Lack of documentation of scientific evaluation when expedited • Initial Application and Continuing Review Process: Lack of documentation of application & continuing review processes, particularly of humanitarian devices; and of risk determination • FDA Reporting: Suspended, terminated study not reported • Informed Consent Forms: Discomforts for venipunctures and mammograms were not included

  3. FDA Audit Response Actions Completed, June 1 2010 • Response to FDA Audit 483 MX-4501N 20100317 114032 3-10: • Nine Category 483 Citations • Meetings • Minutes: Votes for, against, abstention and reason not recorded; controverted [sic: controversial] discussions not summarized • Diversity: Meeting convened without a non-scientific member • Teleconferencing Participation: Lack of documentation of materials supplied to teleconferencing member • Interim Convened Meetings: Lack of documentation of provision for and recording of materials provided at Interim convened meetings • Suspension Reporting: A study’s accrual suspension was not reported to the FDA • Membership • Membership rosters: Lack of documentation of scientific vs. non-scientific designation and of affiliate vs. non-affiliate and voting status

  4. FDA Audit Response Actions Completed, June 1 2010 • Response to FDA Audit 483 MX-4501N 20100317 114032 3-10: • Nine Category 483 Citations (continued) • Investigator Responsibilities • Investigator Compliance: Compliance by Principal Investigator is not prospectively surveyed • Documentation • Electronic Recording and Processing: Electronic method not CFR “part 11” compliant; March-April 2008 files missing • Serious Adverse Events: Lack of documentation of scientific evaluation when expedited • Initial Application and Continuing Review Process: Lack of documentation of application & continuing review processes, particularly of humanitarian devices; and of risk determination • FDA Reporting: Suspended, terminated study not reported • Informed Consent Forms: Discomforts for venipunctures and mammograms were not included

  5. MULTI-DISCIPLINARY QUALITY ASSURANCE SUMMARY – August 2010

  6. MULTI-DISCIPLINARY QUALITY ASSURANCE SUMMARY QUALITY GOALS

  7. GOAL #3: Comply with federal and state human researchregulations • Federal • Compliance with Code of Federal Regulations related to human research and research protections (45CFR46, 21CFR50, 21CFR56) • Successful conduct and completion of FDA, DHHS Office of Human Research Protections (OHRP) requirements, and of sponsor audits • State • SB 1025: Genetic Testing Opt-Out • SB316: Clinical Trial Coverage by Health Insurance Companies

  8. GOAL #3: Comply with federal and state human researchregulations • Process • Submission, distribution, review, approval and modification of • 1) clinical research applications • 2) informed consent, assent and HIPAA forms and revisions • 3) protocol amendments and revisions • 4) annual continuing renewal applications • 5) human device exemptions • 6) serious adverse effects (all local and selected study-wide adverse events) • 7) protocol deviations and violations • 8) accrual suspensions • 9) advertising materials • 10) investigator brochures • 11) sponsor memoranda • 12) subject and data confidentiality • 13) product information • 14) study closures, final reports and publications • 15) other changes, communications and directives regarding clinical research • Support surveillance and reporting of clinical research activity not being monitored by the IRB

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