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, Karen Hartman, Lisa A. Speicher, Joan E. Adamo, Gerri O'Riordan, Jennifer Swanton Brown, Kathryn G. Schuff

Research output: Contribution to journalArticle

1 Scopus citations

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 sponsorinvestigators 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 AdministrationYregulated 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.

Original languageEnglish (US)
Pages (from-to)797-803
Number of pages7
JournalJournal of Investigative Medicine
Volume62
Issue number5
DOIs
StatePublished - Jun 2014

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Keywords

  • Academic Health Center
  • Clinical and Translational Science Award
  • FDA-regulated research
  • Investigational Device Exemption
  • Investigational New Drug
  • Regulatory knowledge
  • Sponsor-investigator

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)

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