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Research article

First published 1987-4

The Interrelationships of Sponsors,Clinical Investigators,and Institutional Review Boards

Thomas J. Kirsch

Therapeutic Innovation & Regulatory Science

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Research article

First published 1988-4

FDA Inspection of Clinical Research Sponsors and Investigators: Avoiding the Pitfalls

C. Stephen Lawrence

Therapeutic Innovation & Regulatory Science

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Research article

First published 2009-8

Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators

M. E. Blair Holbein

Journal of Investigative Medicine

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Research article

First published 2014-6

Recommendations from the Investigational New Drug/Investigational Device Exemption Task Force of the Clinical and Translational Science Award Consortium: Developing and Implementing a Sponsor-Investigators Training Program

M. E. Blair Holbein, Jelena Petrovic Berglund, Erin K. O'Reilly [...]

Journal of Investigative Medicine

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Research article

First published 2012-12

Academic investigator-initiated trials and the challenge of sponsor responsibility: the Cologne Sponsor Model

Christine Georgias, Andrea Grunow, Miriam Olderog [...]

Clinical Trials

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Other

First published 1999-7

FDA Clinical Investigator Site Inspections: The Sponsor's Role

Richard D. Huddleston

Therapeutic Innovation & Regulatory Science

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Research article

First published 2013-11

The Sponsor-Event Geographical Match as a Dimension of Event-Sponsor Fit: An Investigation in Europe and North America

François A. Carrillat, Alain d'Astous, Victor Davoine

Australasian Marketing Journal

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Research article

First published 2012-10

Understanding Food and Drug Administration Regulatory Requirements for an Investigational Device Exemption for Sponsor-Investigators

M. E. Blair Holbein, Jelena Petrovic Berglund

Journal of Investigative Medicine

Open access

Research article

First published 2017-6

Sponsors’ and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials

Raymond Perez, Patrick Archdeacon, Nancy Roach [...]

Clinical Trials

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Research article

First published 1988-4

Sponsor Education of Clinical Investigators in the Clinical Research Process

Thomas J. Kirsch

Therapeutic Innovation & Regulatory Science

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