Just as clinical research protocols have been growing more complex,so have the structures and relationships of the organizations that conduct them. Study sponsors often engage numerous contract research organizations (CROs) and other service providers in a study. While the concept of the “principal investigator” survives in the world of regulatory compliance,that person almost always operates, not as an individual, but as the owner or employee of a clinic, hospital, health system, or other clinical research site, which draw on the resources of other organizations (referred to in the regulations as “institutions” or“facilities”).
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