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A "research sponsor" in the context of clinical trials refers to an individual, company, institution, or organization that takes responsibility for initiating, managing, and funding a clinical trial, but does not directly conduct the research themselves; essentially, they are the entity that financially backs and oversees the entire clinical trial process, ensuring its compliance with regulations and ethical standards.
Key points about research sponsors in clinical trials:
They design the study protocol, recruit research sites, select investigators, monitor data collection, and report results to regulatory agencies.
Examples of sponsors:
Pharmaceutical companies, government agencies like the NIH, academic institutions, or private organizations.
Distinction from investigators:
While the sponsor initiates and funds the trial, the investigators are the healthcare professionals at research sites who directly interact with study participants and collect data.
Sponsor-investigator:
In some cases, an individual can act as both the sponsor and investigator, meaning they design, fund, and conduct the study themselves.