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Documentation: Essential Documents and Standard Operating Procedures

In: Principles and Practice of Clinical Trials

Author

Listed:
  • Eleanor McFadden

    (Frontier Science (Scotland) Ltd., Kincraig)

  • Julie Jackson

    (Frontier Science (Scotland) Ltd, Grampian View)

  • Jane Forrest

    (Frontier Science (Scotland) Ltd, Grampian View)

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.

Suggested Citation

  • Eleanor McFadden & Julie Jackson & Jane Forrest, 2022. "Documentation: Essential Documents and Standard Operating Procedures," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 20, pages 369-387, Springer.
    • Handle: RePEc:spr:sprchp:978-3-319-52636-2_45
    DOI: 10.1007/978-3-319-52636-2_45
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