Starting a Clinical Research Team
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.
KeywordsMedical background Attention to detail Greater good Clinical disclosure agreement Budget Clinical trial agreement or contract Consent Chart documents
- 1.Medicare Coverage — Clinical Trials: Final National Coverage Decision. 2013. https://www.cms.gov/Medicare/Coverage/Clinical Trial Policies/downloads.
- 2.Your Medicare Coverage: Clinical Research studies. 2018. https://www.medicare.gov/coverage/clinical-research-studies.html.