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Journal of Investigative Medicine:
doi: 10.231/JIM.0000000000000083
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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

Holbein, M. E. Blair PhD, BCAP*; Berglund, Jelena Petrovic PhD, RAC; O’Reilly, Erin K. PhD, RAC; Hartman, Karen MSN, RN, CHRC; Speicher, Lisa A. PhD§; Adamo, Joan E. PhD; O’Riordan, Gerri RN; Brown, Jennifer Swanton RN**; Schuff, Kathryn G. MD, MCR††

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The objective of this study was to provide recommendations for provision of training for sponsor and investigators at Academic Health Centers.


A subgroup of the Investigational New Drug/Investigational Device Exemption (IND/IDE) Task Force of the Clinical and Translational Science Award (CTSA) program Regulatory Knowledge Key Function Committee was assembled to specifically address how clinical investigators who hold an IND/IDE and thus assume the role of sponsor-investigators are adequately trained to meet the additional regulatory requirements of this role.


The participants who developed the recommendations were representatives of institutions with IND/IDE support programs. Through an informal survey, the task force determined that a variety and mix of models are used to provide support for IND/IDE holders within CTSA institutions. In addition, a CTSA consortium-wide resources survey was used. The participants worked from the models and survey results to develop consensus recommendations to address institutional support, training content, and implementation.


The CTSA IND/IDE Task Force recommendations are as follows: (1) Institutions should assess the scope of Food and Drug Administration–regulated research, perform a needs analysis, and provide resources to implement a suitable training program; (2) The model of training program should be tailored to each institution; (3) The training should specifically address the unique role of sponsor-investigators, and the effectiveness of training should be evaluated regularly by methods that fit the model adopted by the institution; and (4) Institutional leadership should mandate sponsor-investigator training and effectively communicate the necessity and availability of training.

Copyright © 2014 by The American Federation for Medical Research


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