Open AccessStandard operating procedures for clinical research personnel—part 5
Author(s) -
Bohaychuk Wendy,
Ball Graham
Publication year - 2000
Publication title -
the quality assurance journal
Language(s) - English
Resource type - Journals
eISSN - 1099-1786
pISSN - 1087-8378
DOI - 10.1002/1099-1786(200012)4:4<211::aid-qaj122>3.0.co;2-2
Subject(s) - harmonization , food and drug administration , best practice , administration (probate law) , standard operating procedure , business , engineering management , medicine , engineering , operations management , political science , risk analysis (engineering) , law , physics , acoustics
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 © 2000 John Wiley & Sons, Ltd.