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ERIC Number: EJ1155568
Record Type: Journal
Publication Date: 2016
Pages: 5
Abstractor: As Provided
ISSN: ISSN-1539-1590
Spotlight on Clinical Trial Sponsorship
Mounce, Doug; Curci, Frank X.; Fortenbery, Joshua B.
Journal of Research Administration, v47 n1 p58-67 Spr 2016
What liability is associated with assuming the role of the "sponsor" in a clinical trial? This article discusses the Food and Drug Administration (FDA) regulations governing sponsorship, and how courts have interpreted those regulations in cases with a claim of injury. There is a natural concern with the responsibility implied by assuming the role of "sponsor" in a clinical trial agreement. In a commercially sponsored clinical trial, for example, the site can reasonably require that a drug company assume most liability for subject injury Pharmaceutical companies are not the sponsor, however, for Investigator Sponsored Trials (ISTs, sometimes called Investigator Initiated Trials IITs). Between these extremes are the complex cases where a mix of delegated roles and responsibilities are assigned, and where the "duty of care" relation between a physician and their patient may take precedence in any case. This article discusses sponsorship in terms of the FDA regulations, and reviews several cases where judicial interpretation of a sponsor's duties had an impact on liability.
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Publication Type: Journal Articles; Reports - Evaluative
Education Level: Higher Education
Audience: N/A
Language: English
Sponsor: N/A
Authoring Institution: N/A
Grant or Contract Numbers: N/A