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Starting a Clinical Research Team

  • Cara East
Chapter

Abstract

It is possible to start a clinical research team with only one doctor and one nurse, but there are many tasks to be done. It is generally preferable to add individuals with a medical background, but clinical research is more detail-oriented and team members must be comfortable that a placebo, inactive device, or sham procedure is being used. Processes are lengthy, and the best staff are those who are good at different tasks. Start-up procedures include executing a clinical disclosure agreement (CDA), negotiating a contract, developing a budget, and writing a good consent.

Keywords

Medical background Attention to detail Greater good Clinical disclosure agreement Budget Clinical trial agreement or contract Consent Chart documents 

References

  1. 1.
    Medicare Coverage — Clinical Trials: Final National Coverage Decision. 2013. https://www.cms.gov/Medicare/Coverage/Clinical Trial Policies/downloads.
  2. 2.
    Your Medicare Coverage: Clinical Research studies. 2018. https://www.medicare.gov/coverage/clinical-research-studies.html.

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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