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Standard operating procedures for clinical research personnel—part 5

✍ Scribed by Wendy Bohaychuk; Graham Ball

Publisher
John Wiley and Sons
Year
2000
Tongue
English
Weight
88 KB
Volume
4
Category
Article
ISSN
1087-8378

No coin nor oath required. For personal study only.

✦ Synopsis

This is the fifth 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 Organizations (CROs). The procedures include those required by the International Conference on Harmonization (ICH), the USA Food and Drugs Administration (FDA), many other guidelines and regulations, and 'best practice' observed by the authors. The model forms require modification for actual use. (The full text of all 101 SOPs is available from the authors). Copyright

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