Name: good clinical practice
SKU: 19425064
Price: 63.44 EUR
Availability: InStock
Author: Allport-Settle, Mindy J.
ISBN: 9780982147672

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Type

Physical Book

Author

Mindy J. Allport-Settle

Publisher

Pharmalogika

Year

2010

Language

English

Pages

712

Format

Paperback

Dimensions

22.9x15.2x3.6 cm

Weight

0.93 kg.

ISBN

0982147678

ISBN13

9780982147672

Synopsis "good clinical practice"

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

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good clinical practice - Allport-Settle, Mindy J.

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