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Study Closeout

  • Cara East
Chapter

Abstract

Study closure procedures only begin with the subject final visits but also involve multiple other steps. Subject contact information should be updated, and all study paraphernalia should be collected. All final entries should be made into the electronic case report forms (eCRFs) and all queries answered. As part of the closeout, the delegation of authority log should be completed with the termination of involvement of all staff noted by their signatures. Final payments should be procured and all financial conflicts of interest reported. Final visits or letters with the randomization information should be sent to the subjects, and a list of closure documents should be assembled and stored indefinitely on-site.

Keywords

Contact information Study drug Study equipment Queries Delegation of authority logs Randomization information 

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  • Cara East
    • 1
  1. 1.Baylor Soltero CV ResearchBaylor University Medical CenterDallasUSA

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