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Regulation of Clinical Trials

Regulation of Clinical Trials . Robert Silbergleit, MD Department of Emergency Medicine NETT Clinical Coordinating Center. Good Clinical Practice (GCP). FDA 21 CFR 50-56. + Common Rule 45 CFR 46. 17. IRB. PI. Sponsor. Funder/IC. DSMB.

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Regulation of Clinical Trials

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  1. Regulation of Clinical Trials Robert Silbergleit, MDDepartment of Emergency MedicineNETT Clinical Coordinating Center

  2. Good Clinical Practice (GCP) FDA 21 CFR 50-56 + Common Rule 45 CFR 46 17 IRB PI Sponsor Funder/IC DSMB

  3. Longest history of regulationof clinical trials Helsinki principles +/- (1964) Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications Sponsors - initiate and monitor Investigators - plan and perform IRBs - review and approve All drugs and devices in clinical research unless exempt FDA 21 CFR 50-56

  4. Belmont Principles (1979) Beneficence Justice Respect for persons IRB + informed consent requirements Agriculture, Energy, Commerce, HUD, Justice, Defense, Education, VA, Transportation, Homeland, NSF, NASA, EPA, AID, SSA, CIA, CPSC Federally funded research, or research conducted by an institution with an FWA + Common Rule 45 CFR 46 17

  5. Previously OPRR within NIH Compliance oversight Mostly institutional Policy and assurances Federal Wide Assurance (FWA) Registration of IRB’s Education and development Provides guidance Educational programs SACHRP International + Common Rule 45 CFR 46 17 Federal Wide Assurance (FWA) is a commitment by an institution to the HHS to comply with the common rule.

  6. International Conference on Harmonization Helsinki Principles (13 actually) Designing, conducting, recording, reporting trials E6: GCP Consolidated Guideline 1996 Reflect FDA regulations and/or guidance Are conditions for FDA accepting non-US trials Distinct from WHO guidelines for GCP Good Clinical Practice (GCP)

  7. NIH provides Peer review - content expertise Methodology Human subjects protection Funding Ongoing review CSR PI Funder/IC DSMB

  8. Institutional or independent role of central IRB’s Implement/interpret the reg’s Composition Relatively little content expertise Consider local context Communicate with investigators Review and approve applications Review ongoing safety and conduct Unfunded mandates Accreditation controversy IRB PI Sponsor Funder/IC DSMB

  9. Work for Sponsor or the Funder Advice on safety/performance during the ongoing trial Composition variable Mandate is variable IRB PI Sponsor Funder/IC DSMB

  10. Good Clinical Practice (GCP) FDA 21 CFR 50-56 IRB PI Sponsor DSMB

  11. + Common Rule 45 CFR 46 17 IRB PI Funder/IC DSMB

  12. Good Clinical Practice (GCP) FDA 21 CFR 50-56 + Common Rule 45 CFR 46 17 IRB PI Sponsor Funder/IC DSMB

  13. FDA 21 CFR 50-56 IRB PI Sponsor Funder/IC DSMB

  14. Good Clinical Practice (GCP) FDA 21 CFR 50-56 + Common Rule 45 CFR 46 17 IRB PI Sponsor Funder/IC DSMB

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