Documentation: Essential Documents and Standard Operating Procedures

Eleanor McFadden (), Julie Jackson () and Jane Forrest ()
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Eleanor McFadden: Frontier Science (Scotland) Ltd., Kincraig
Julie Jackson: Frontier Science (Scotland) Ltd, Grampian View
Jane Forrest: Frontier Science (Scotland) Ltd, Grampian View

Chapter 20 in Principles and Practice of Clinical Trials, 2022, pp 369-387 from Springer

Abstract: Abstract Documentation is a critical component of clinical trials. There are requirements not only to be able to verify that the data being analyzed is accurate but that it was collected and processed in a consistent way. Anyone involved in a trial has to recognize the documentation requirements and ensure that they are met. The International Conference on Harmonization (ICH) Guidelines on Good Clinical Practice E6 provides details of standards to be met along with relevant definitions. This chapter provides guidance on identifying essential documents for a trial and also on how to develop and maintain systems for standard operating procedures.

Keywords: Documentation; Standard operating procedures; Trial master file; Essential documents (search for similar items in EconPapers)
Date: 2022
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DOI: 10.1007/978-3-319-52636-2_45

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