Archiving Records and Materials

Winifred Werther () and Curtis L. Meinert ()
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Winifred Werther: Amgen Inc, Center for Observational Research
Curtis L. Meinert: Johns Hopkins University, Department of Epidemiology, School of Public Health

Chapter 34 in Principles and Practice of Clinical Trials, 2022, pp 637-648 from Springer

Abstract: Abstract An archive, in the context of a trial, is a collection of documents and records relevant to the design and conduct of the trial maintained as a historical repository. Archiving is a process that starts before the first person is enrolled and continues to the end of the trial when all analyses are complete and the investigator group disbands. So, when a trial is finished, money has run out, and investigators have dispersed, what do you have archived and where? The answer to the first question is “everything you may need later,” and the answer to the second is “someplace readily accessible far into the foreseeable future.” Both answers are correct but not helpful because the first question requires a crystal ball of what might be needed and the second requires a place like the Smithsonian and there are no Smithsonians for archiving records of clinical trials. This chapter is about the process of archiving and about what to archive.

Keywords: Trial master file; Archiving; Electronic (search for similar items in EconPapers)
Date: 2022
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DOI: 10.1007/978-3-319-52636-2_62

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