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

Archer Eller, MS Clinical Trial Manager

Pulmonology 353-2060 [email protected]

}  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

HHS

OHRP Title 45 CFR

Public Welfare

Part 46 National Research Act 1974

Title 45 Protection of Human Subjects

IRBs 1978 Belmont

Report

Applications: Informed Consent, Assessment of Risks and Benefits, and Selection of Subjects

FDA Title 21 CFR

Food and Drugs

Interpretation of the Federal Food, Drug, and Cosmetic Act

ICH E6 GCP

ICH

www.fda.gov, www.hhs.gov

}  International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

FDA GCP 2011 Reference Guide

}  “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

}  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

}  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

}  The investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies)

FDA GCP 2011 Reference Guide

}  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

}  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

}  Review contracts }  Contact sponsor }  Record all communications }  SOP at

http://hub.ucsf.edu/fda-and-ohrp-inspections

}  FDA and monitoring history }  Guidelines }  UCSF help }  Questions