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FDA Audit Citations Response: Findings and Quality Assurance Actions Summary

This document outlines the findings from the FDA audit (483) report of March 2010 and the responses taken to address the nine categories of citations. Key issues included lack of meeting minutes, absence of non-scientific members in discussions, documentation deficiencies in teleconferencing, and shortcomings in reporting serious adverse events. The document emphasizes compliance with federal and state human research regulations, highlighting actions taken to ensure adherence to established protocols and ethical standards in clinical research.

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FDA Audit Citations Response: Findings and Quality Assurance Actions Summary

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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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