Standard operating procedures for clinical research personnel - Part 20

Autor:	Wendy Bohaychuk, C D Graham Ball
Rok vydání:	2004
Předmět:	Food and drug administration Clinical research business.industry Best practice Operating procedures Medicine (miscellaneous) Medicine Operations management business Pharmacology Toxicology and Pharmaceutics (miscellaneous) Actual use
Zdroj:	The Quality Assurance Journal. 8:110-114
ISSN:	1099-1786 1087-8378
DOI:	10.1002/qaj.266
Popis:	This is the twentieth in a series of articles containing proposals for wording and content of Standard Operating Procedures (SOPs) for clinical research activities conducted by sponsors and Contract Research Organisations (CROs). The procedures include those required by the International Conference on Harmonisation (ICH), the Food and Drug Administration (FDA), many other guidelines and regulations, and 'best practice' observed by the authors. The model forms require modification for actual use. In this article, SOPs are presented for management of safety events: definitions for assessing safety events and sources of safety information (SOP 601); recording and reporting adverse events (SOP 602). (The full text of all 101 SOPs is available from the authors.) Copyright © 2004 John Wiley & Sons, Ltd.
Databáze:	OpenAIRE
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