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Recommendations From the Investigational New Drug/Investigational Device Exemption Task Force of the Clinical and Translational Science Award Consortium
  1. M. E. Blair Holbein, PhD, BCAP*,
  2. Jelena Petrovic Berglund, PhD, RAC,
  3. Erin K. O’Reilly, PhD, RAC,
  4. Karen Hartman, MSN, RN, CHRC,
  5. Lisa A. Speicher, PhD§,
  6. Joan E. Adamo, PhD,
  7. Gerri O’Riordan, RN,
  8. Jennifer Swanton Brown, RN**,
  9. Kathryn G. Schuff, MD, MCR††
  1. From 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.
  1. Received December 6, 2013, and in revised form February 22, 2014.
  2. Accepted for publication February 24, 2014.
  3. Reprints: M. E. Blair Holbein, PhD, BCAP, Department of Clinical Sciences, Center for Translational Medicine, UT Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390-9066. E-mail: Blair.Holbein{at}UTSouthwestern.edu.
  4. Supported by the National Center for Advancing Translational Sciences/National Center for Research Resources of the National Institutes of Health Grant nos. UL1TR000451, UL1TR001117, UL1RR024128, UL1RR024150, UL1TR000135, UL1TR000003, UL1TR000042, UL1TR000128, and UL1RR UL1 024120. The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health, National Center for Advancing Translational Sciences, or National Center for Research Resources.
  5. The authors have no potential conflicts of interest to declare.

Developing and Implementing a Sponsor-Investigators Training Program

Abstract

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.

Key Words
  • Clinical and Translational Science Award
  • regulatory knowledge
  • FDA-regulated research
  • sponsor-investigator
  • Investigational New Drug
  • Investigational Device Exemption
  • Academic Health Center

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