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

J Investig Med. 2014 Jun;62(5):797-803. doi: 10.2310/JIM.0000000000000083.


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.

Publication types

  • Research Support, N.I.H., Extramural
  • Review

MeSH terms

  • Advisory Committees / standards*
  • Device Approval / standards*
  • Drugs, Investigational / standards*
  • Education / methods
  • Education / standards
  • Humans
  • Program Development / methods
  • Program Development / standards*
  • Research Personnel / education
  • Research Personnel / standards
  • Translational Research, Biomedical / education*
  • Translational Research, Biomedical / methods
  • Translational Research, Biomedical / standards*


  • Drugs, Investigational