Literaturnachweis - Detailanzeige
| Autor/inn/en | Mounce, Doug; Curci, Frank X.; Fortenbery, Joshua B. |
|---|---|
| Titel | Spotlight on Clinical Trial Sponsorship |
| Quelle | In: Journal of Research Administration, 47 (2016) 1, S.58-67 (5 Seiten)Infoseite zur Zeitschrift
PDF als Volltext kostenfreie Datei |
| Sprache | englisch |
| Dokumenttyp | gedruckt; online; Zeitschriftenaufsatz |
| ISSN | 1539-1590 |
| Schlagwörter | Public Agencies; Pretesting; Federal Regulation; Donors; Research Administration; Performance Contracts; Court Litigation; Administrator Responsibility; Administrator Role; Higher Education; Administrative Principles |
| Abstract | 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. (As Provided). |
| Anmerkungen | Society of Research Administrators International. 500 North Washington Street Suite 300, Falls Church, VA 22046. Tel: 703-741-0140; Fax: 703-741-0142; e-mail: membership@srainternational.org; Web site: http://www.srainternational.org |
| Erfasst von | ERIC (Education Resources Information Center), Washington, DC |
| Update | 2020/1/01 |
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