Standard operating procedures for clinical research personnel - Part 21
| Autor: | C D Graham Ball, Wendy Bohaychuk |
|---|---|
| Rok vydání: | 2004 |
| Předmět: |
medicine.medical_specialty
business.industry Operating procedures Best practice Alternative medicine Medicine (miscellaneous) medicine.disease Food and drug administration Clinical research medicine Medical emergency Adverse effect business Pharmacology Toxicology and Pharmaceutics (miscellaneous) Actual use |
| Zdroj: | The Quality Assurance Journal. 8:183-194 |
| ISSN: | 1099-1786 1087-8378 |
| DOI: | 10.1002/qaj.280 |
| Popis: | This is the 21st 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: recording and reporting serious adverse events (SOP 603); and reporting safety information externally (SOP 604). (The full text of all 101 SOPs is available from the authors.) Copyright © 2004 John Wiley & Sons, Ltd. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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