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Annual Reviews and Financial Disclosures

  • Cara East
Chapter

Abstract

The annual review is a good time to take stock of how a study is progressing. Assessment of the number of subjects, their ages, gender, race, and ethnicity should be reviewed. It is important to recognize if there has been any disproportionate recruiting of subgroups. Special attention should be given to any vulnerable or disadvantaged subjects who were enrolled. Issues with obtaining informed consent should be rigorously reviewed and any corrective actions taken and reviewed with all staff. Other important information includes information about subject injuries, subject complaints, subjects withdrawn due to complications from the study, and any subjects who voluntarily withdrew their consent for participating in the study. Finally, all staff members will complete a conflict of financial interest for each study yearly.

Keywords

Consents Special populations Subject injuries Subject withdrawals Adverse events Serious adverse events Suspected unexpected serious adverse events (SUSARs) Protocol deviations Financial conflicts of interest 

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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