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
| Autor: | Gerri O'Riordan, Kathryn G. Schuff, Karen A. Hartman, M. E. Blair Holbein, Jelena P. Berglund, Jennifer Swanton Brown, Erin K. O'Reilly, Joan E. Adamo, Lisa A. Speicher |
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| Rok vydání: | 2014 |
| Předmět: |
Medical education
Scope (project management) Device Approval business.industry media_common.quotation_subject Investigational New Drug General Medicine Investigational device exemption General Biochemistry Genetics and Molecular Biology Clinical and Translational Science Award Medicine Mandate Needs analysis business Function (engineering) media_common |
| Zdroj: | Journal of Investigative Medicine. 62:797-803 |
| ISSN: | 1708-8267 1081-5589 |
| DOI: | 10.2310/jim.0000000000000083 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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