principles of gcp - intro

8/8/2019 Principles of GCP - Intro

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Good Clinical Practices (GCP)

GCPs are a collection of regulations, guidelinesand practices

GCPs are a standard by which clinical trials aredesigned, implemented and reported to assurethat data are creditable and the trial subjects areprotected


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GCP regulations and guidelines

Investigator Responsibilities

Sponsor Responsibilities Monitoring

IRB/IBC Responsibilities


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GCP regulations and guidelines


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FDA (CFR Title 21 citations) www.fda.gov Part 11 Electronic Records; Electronic Signatures

Part 50 Protection of Human Subjects

Part 54 FinancialDisclosure by Clinical Investigators Part 56 Institutional Review Boards

Part 312 Investigational NewDrugApplication IND application (subpart B)

Administrative actions (subpart C)

Responsibilities of Sponsors and Investigators (subpart

D)

Part 314 New DrugApplication (NDA)

Part 600 Biological Products: General


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ICH www.ich.org ICH-E6 Good Clinical Practice

Principles of ICH GCP

IRB/IEC Investigator

Sponsor

Clinical trial protocol and amendments

Investigators brochure (IB)

Essential documents for the clinical trial Several other guidances (quality, safety, efficacy,

multidiscCTMlinary)


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FDA Guidances (some examples):

Guideline of Monitoring of Clinical Investigators

Computerized Systems used in Clinical Trials

FDAs internal Compliance Program Guidances(FDA/ORA)

FDA Information Sheets

Separate set of clinical investigator information sheets

NIH OBAwww4.od.nih.gov/oba NIH Guideline (April 2002)


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Need to submit an IND for each Clinical Trial Materialused in a clinical investigation Notice of Claimed Investigational Exemption for a NewDrug

FDA reviews an IND to ensure the safety, 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: Traditional (sponsor initiated or sponsor-investigator initiated)

Treatment Use

Emergency Use


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Introductory statement and Generalinvestigational plan Overview of the objective for the intended clinical study/design

Investigators Brochure (IB) Essentially the beginning of the package insert

Clinical Protocol and Investigator qualifications Protocol, ICF, 1572, IRB approval documentation

Chemistry, Manufacturing and Controls (CMC)

Product information, manufacturing facility information Pharmacology and ToxicologyData

Pre-clinical data/studies


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Investigational new drugs may be used in a clinicaltrial if the following is met:

Sponsor submits IND and IND is in effect

Sponsor conducts investigation in compliance with GCPCFR regulations and guidances

Investigator conducts investigation in compliance with GCPCFR regulations and guidances

principles of gcp - intro

Documents