| Abstrakt: |
This is the eighth 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 the management of case report forms (CRFs) including preparation (SOP 310), review, approval and amendment (SOP 311) and printing and distribution (SOP 312). SOPs are also presented for compilation of documents for submission to regulatory authorities (SOP 313) and documentation of review and approval by regulatory authorities. (The full text of all 101 SOPs is available from the authors.) Copyright © 2001 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR] |
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