Abstract
AbstractWe describe a principle of reviewing documents, particularly those relating to clinical studies, under constraints of time and/or manpower. This principle can be expressed formally in a manner that shows how to choose which processes to conduct and which to jettison, when external constraints prohibit the performance of all quality control (QC) steps with arbitrarily great thoroughness. We classify the major steps in reviewing clinical study documents on this basis, thus providing suggested ‘do’s and ‘don’t's for planning QC of documents. However, to optimise the value of a QC review under the constraint of limited resources, it is important to rank the tasks according to their utility for the document's value, and this may require procedures to be refined on a project‐by‐project basis. Copyright © 2004 John Wiley & Sons, Ltd.
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