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Recommendations from the Investigational New Drug/Investigational Device Exemption Task Force of the clInical and
M E Blair Holbein1, Jelena Petrovic Berglund, Erin K O'Reilly
1From the *Department of Clinical Sciences, Center for Translational Medicine, UT Southwestern Medical Center, Dallas, TX; †Duke Translational Medicine Institute, Duke University School of Medicine, Durham, NC; ‡Integrity and Compliance Office, Mayo Clinic, Center for Clinical and Translational Science, Rochester, MN; §Perelman School of Medicine, The University of Pennsylvania, Office of Clinical Research, Philadelphia, PA; ∥Biomedical Engineering, Clinical & Translational Science Institute, University of Rochester Medical Center, Rochester, NY; ¶Department of Pediatrics, **Spectrum, Stanford Center for Clinical and Translational Research and Education, Stanford University School of Medicine, Stanford, CA; and ††Department of Medicine/Division of Endocrinology, Oregon Clinical and Translational Research Institute, Oregon Health & Science University, Portland, OR.
Objective:
The objective of this study was to provide recommendations for provision of training for sponsor and investigators at Academic Health Centers.
Background:
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.
Methods:
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.
Recommendations:
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.
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