Good Clinical Practice - Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 1, Regulations (Paperback)

Topics covered include: * A brief description of the history and development of clinical research and good clinical practice * Title 21 CFR Parts 11, 50, 54, 56, 58, 210, 312, 314, 320, 511, 514, 601, 812, and 814 * FDA and ICH GCP Standards for Clinical Research * Form FDA 1572-Statement of Investigator * Informed Consent * Patient Recruitment * State Standards and GCP * Source Data/Documentation * Investigator/Site Requirements * Clinical Monitoring * Clinical Study Safety Reporting * Clinical Trial Protocols/Protocol Changes/Protocol Violations * Institutional Review Boards * Quality Assurance Activities/Study Auditing/FDA Inspections * Investigational Drug Accountability, Administration, and Labeling

General

Imprint:	Pharmalogika
Country of origin:	United States
Release date:	August 2010
First published:	August 2010
Authors:	Mindy J. Allport-Settle
Dimensions:	229 x 152 x 36mm (L x W x T)
Format:	Paperback - Trade
Pages:	712
ISBN-13:	978-0-9821476-7-2
Categories:	Books > Medicine > Clinical & internal medicine > General
LSN:	0-9821476-7-8
Barcode:	9780982147672

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