guidelines and practices ƒ GCPs are a standard by which clinical trials are designed. implemented and reported to assure that data are creditable and the trial subjects are protected ƒ .Š Good Clinical Practices (GCP) GCPs are a collection of regulations.

Š Š Š GCP regulations and guidelines Investigator Responsibilities Sponsor Responsibilities ƒ Monitoring Š IRB/IBC Responsibilities .

GCP regulations and guidelines .

Industry Standard All products .Organization CBER Oversight Biologics/gene therapy (Therapeutics and Vaccines) Gene Therapy (other recombinant DNA molecules) Regulation and/or guidance Regulations and Guidances NIH OBA ICH Guidance Guidances.

fda.Š FDA (CFR Title 21 citations) www.gov ƒ ƒ ƒ ƒ ƒ Part 11 ² Electronic Records. Electronic Signatures Part 50 ² Protection of Human Subjects Part 54 ² Financial Disclosure by Clinical Investigators Part 56 ² Institutional Review Boards Part 312 ² Investigational New Drug Application IND application (subpart B) Administrative actions (subpart C) Responsibilities of Sponsors and Investigators (subpart D) ƒ ƒ Part 314 ² New Drug Application (NDA) Part 600 ² Biological Products: General .

org ƒ ICH-E6 ² Good Clinical Practice Principles of ICH GCP IRB/IEC Investigator Sponsor Clinical trial protocol and amendments Investigator·s brochure (IB) Essential documents for the clinical trial ƒ Several other guidances (quality.Š ICH www. safety. multidiscCTMlinary) .ich. efficacy.

nih.od.Š FDA Guidances (some examples): Guideline of Monitoring of Clinical Investigators ƒ Computerized Systems used in Clinical Trials ƒ FDA·s internal Compliance Program Guidances (FDA/ORA) ƒ Š FDA Information Sheets ƒ Separate set of clinical investigator information sheets NIH Guideline (April 2002) Š NIH OBA www4.gov/oba ƒ .

quality & efficacy of the product and to protect the safety & welfare of the human subjects IND regulations are located in Title 21 CFR Part 312 Types of INDs: ƒ Traditional (sponsor initiated or sponsor-investigator initiated) ƒ Treatment Use ƒ Emergency Use .Š Need to submit an IND for each Clinical Trial Material used in a clinical investigation ƒ Notice of Claimed Investigational Exemption for a New Drug Š Š Š FDA reviews an IND to ensure the safety.

manufacturing facility information Pre-clinical data/studies Š Š Š Š Investigator·s Brochure (IB) ƒ Clinical Protocol and Investigator qualifications ƒ Chemistry. ICF. Manufacturing and Controls (CMC) ƒ Pharmacology and Toxicology Data ƒ .Š Introductory statement and General investigational plan ƒ Overview of the objective for the intended clinical study/design Essentially the beginning of the package insert Protocol. IRB approval documentation Product information. 1572.

Š Investigational new drugs may be used in a clinical trial if the following is met: ƒ Sponsor submits IND and IND is in effect ƒ Sponsor conducts investigation in compliance with GCP CFR regulations and guidances ƒ Investigator conducts investigation in compliance with GCP CFR regulations and guidances .

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