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.
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Medicare Coverage — Clinical Trials: Final National Coverage Decision. 2013. https://www.cms.gov/Medicare/Coverage/Clinical Trial Policies/downloads.
Your Medicare Coverage: Clinical Research studies. 2018. https://www.medicare.gov/coverage/clinical-research-studies.html.
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East, C. (2018). Starting a Clinical Research Team. In: Developing a Successful Clinical Research Program. Springer, Cham. https://doi.org/10.1007/978-3-319-54693-3_4
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DOI: https://doi.org/10.1007/978-3-319-54693-3_4
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