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Standard operating procedures for clinical research personnel—part 2

✍ Scribed by Wendy Bohaychuk; Graham Ball

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

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✦ Synopsis

n this paper, nine SOPs for general topics in clinical research management are addressed. They cover the following topics:

Clinical study plans, including authorizations for studies and clinical study tracking (SOPs 106, 107, 108 and 109): these must be prepared for each individual study as a prerequisite for formal authorization to proceed with the proposed study and to ensure that all necessary resources are available before procedures for setting up the study are undertaken. The procedures for preparation, review, approval, amendment and distribution of clinical study plans must also be described in the SOPs. Clinical research personnel (SOPs 110, 111, 112, 113 and 114): all personnel must be appropriately qualified, experienced and trained prior to undertaking assigned tasks in the management of clinical studies.

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