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Good
Clinical Practice in FDA-Regulated Clinical Trials.
Good Clinical Practice is a standard for the design, conduct,
performance, monitoring, auditing, recording, analysis, and reporting of
clinical trials. Compliance with this standard assures that the data and
reported results are credible and accurate and that the rights, safety,
and well-being of trial subjects are protected.
General
Considerations for Clinical Trials.  This guidance
document describes general principles for conduct, performance, and control of clinical
trials.
Statistical
Principles for Clinical Trials: Availability. This guidance
document provides recommendations to sponsors and scientific experts regarding statistical
principles which when applied to clinical trials for marketing applications will
facilitate the general acceptance of analyses and conclusions drawn from the trials.
Content and Format
of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including
Well-Characterized, Therapeutic, Biotechnology-derived Products .  This guidance clarifies
requirements for data and data presentation related to the initial entry into human
studies for investigational drugs including well characterized therapeutic,
biotechnology-derived products.
Providing
Clinical Evidence of Effectiveness for Human Drugs and Biological Products.
Provides guidance on the quantity of evidence necessary to support effectiveness and
documentation of the quantity of evidence supporting an effectiveness claim.
MaPP
6030.1 Investigational New Drug Process and Review Procedures (Including Clinical Holds).
From CDER's Manual of Policies and Procedures (MaPPs), this MaPP
describes general review principles for IND applications, policies and procedures
for issuing and overseeing clinical holds of INDs, and policies and procedures for
processing and responding to sponsors complete responses to clinical holds.
Guidance for
Industry: Good Clinical Practice Consolidated Guideline. This guidance
document is an international ethical and scientific quality standard for designing,
conducting, recording, and reporting trials that involve the participation of human
subjects. Sections include information on Institutional Review Boards, Investigators,
Sponsors,Clinical Trial Protocol, Investigator's Brochure, and Essential Documents for the
Conduct of a Clinical Trial.
General
Considerations for the Clinical Evaluation of Drugs.
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Clinical Investigators
FDA/Center for Drug Evaluation and Research
Last Updated: October 12, 2001
Originator: OTCOM/DML
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