Open AccessStandard operating procedures for clinical research personnel ‐ Part 14
Author(s) -
Bohaychuk Wendy,
Ball Graham
Publication year - 2002
Publication title -
the quality assurance journal
Language(s) - English
Resource type - Journals
eISSN - 1099-1786
pISSN - 1087-8378
DOI - 10.1002/qaj.198
Subject(s) - documentation , food and drug administration , standard operating procedure , administration (probate law) , best practice , engineering management , engineering , business , operations management , medicine , computer science , medical emergency , political science , law , programming language
This is the 14th 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 monitoring activities: monitoring visits (SOP 401); and documentation of monitoring visits (SOP 402). (The full text of all 101 SOPs is available from the authors.) Copyright © 2002 John Wiley & Sons, Ltd.