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

1. Archer Eller, MS
Clinical Trial Manager
Pulmonology
353-2060 archer.eller@ucsf.edu

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. 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 45
Protection 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. } International Conference on Harmonisation of
Technical Requirements for Registration of
Pharmaceuticals for Human Use
FDA GCP 2011 Reference Guide

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. } 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. } 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. } 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. } 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. } 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. } Review contracts
} Contact sponsor
} Record all communications
} SOP at
http://hub.ucsf.edu/fda-and-ohrp-
inspections

12. } FDA and monitoring history
} Guidelines
} UCSF help
} Questions