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good clinical practice (in English)
Mindy J. Allport-Settle
(Author)
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Pharmalogika
· Paperback
good clinical practice (in English) - Allport-Settle, Mindy J.
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Synopsis "good clinical practice (in English)"
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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All books in our catalog are Original.
The book is written in English.
The binding of this edition is Paperback.
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