Archer Eller, MS         Clinical Trial Manager                   Pulmonology353-2060 archer.eller@ucsf.edu
}  1813 Massachusetts Vaccine Act}  1906 Theodore Roosevelt signed the Pure    Foods and Drug Act (aka “Wiley Act”)}  1...
HHS          OHRP                                        FDA          Title 45 CFR                               Title 21 ...
}    International Conference on Harmonisation of      Technical Requirements for Registration of      Pharmaceuticals fo...
}    “An international ethical and scientific quality      standard for designing, conducting,      recording, and report...
}    A standard for the design, conduct,      performance, monitoring, auditing,      recording, analysis, and reporting ...
}    A systematic and Independent examination of      trial-related activities and documents to      determine whether th...
}    The investigator/institution should permit      monitoring and auditing by the sponsor, and      inspection by the a...
}  To verify:}  1) The rights and well-being of human    subjects are protected.}  2) The reported trial data are accur...
}  Objectives:}  1) To protect the rights, safety, and welfare of    subjects involved in FDA-regulated clinical    tria...
}  Review contracts}  Contact sponsor}  Record all communications}  SOP at    http://hub.ucsf.edu/fda-and-ohrp-    ins...
}  FDA and monitoring history}  Guidelines}  UCSF help}  Questions
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Regulations That Drive Monitoring Visits and FDA Audits: Preparing for a Clinical Research Monitoring Visit

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Presented by Archer Eller, MS, Clinical Trial Manager, UCSF.

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Regulations That Drive Monitoring Visits and FDA Audits: Preparing for a Clinical Research Monitoring Visit

  1. 1. Archer Eller, MS Clinical Trial Manager Pulmonology353-2060 archer.eller@ucsf.edu
  2. 2. }  1813 Massachusetts Vaccine Act}  1906 Theodore Roosevelt signed the Pure Foods and Drug Act (aka “Wiley Act”)}  1927 Renamed the Food and Drug Administration}  1938 FDR signed the new Food, Drug, and Cosmetic Act}  1951 Durham-Humphrey Amendment}  1962 Kefauver-Harris Amendments www.fda.gov, www.wikipedia.com
  3. 3. HHS OHRP FDA Title 45 CFR Title 21 CFR Public Welfare Food and Drugs Part 46 Interpretation of the Federal National Research Act 1974 Food, Drug, and Cosmetic Act Title 45Protection of Human Subjects ICH E6 ICH GCP IRBs 1978 Belmont Report Applications: Informed Consent, Assessment of Risks and Benefits, and Selection of Subjects www.fda.gov, www.hhs.gov
  4. 4. }  International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use FDA GCP 2011 Reference Guide
  5. 5. }  “An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.”}  Objective: Provide a unified standard for the EU, Japan, and the US to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions FDA GCP 2011 Reference Guide
  6. 6. }  A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected FDA GCP 2011 Reference Guide
  7. 7. }  A systematic and Independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, the data recorded, analyzed, and accurately reported according to the protocol, synopsis SOPs, GCP, and the applicable regulatory requirements FDA GCP 2011 Reference Guide
  8. 8. }  The investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies) FDA GCP 2011 Reference Guide
  9. 9. }  To verify:}  1) The rights and well-being of human subjects are protected.}  2) The reported trial data are accurate, complete, and verifiable from source documents.}  3) The conduct of the trial is in compliance with the currently approved protocol/ amendment(s), with GCP, and with applicable regulatory requirement(s) FDA GCP 2011 Reference Guide
  10. 10. }  Objectives:}  1) To protect the rights, safety, and welfare of subjects involved in FDA-regulated clinical trials;}  2) To verify the accuracy and reliability of clinical trial data submitted to FDA in support of research or marketing applications; and}  3) To assess compliance with FDA’s regulations governing the conduct of clinical trials. FDA Compliance Program Guidance Manual 12/8/08
  11. 11. }  Review contracts}  Contact sponsor}  Record all communications}  SOP at http://hub.ucsf.edu/fda-and-ohrp- inspections
  12. 12. }  FDA and monitoring history}  Guidelines}  UCSF help}  Questions

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