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Overview

训练is a crucial component of conducting clinical research. The investigator and all study personnel involved in the design and/or conduct of research involving human subjects are required to receive adequate training. Investigators need to have processes in place for training their study staff on individual protocols and amendments to meet the expectations of the Food and Drug Administration (FDA), additional regulatory bodies and sponsors.

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Statistical design and analysis of research studies 对教育感兴趣的有关研究研究和分析研究的研究者，包括调查和定性方法，可以访问生物统计学和研究设计中心.
哈佛催化剂education and training in clinical and translational research 哈佛催化剂offers numerous online and in-person courses, as well as training programs, ranging from short programs, providing an overview of clinical/translational research, to multi-year, advanced programs for senior fellows and faculty members.
临床研究虚拟导师 Email the临床研究虚拟导师for real-time answers to clinical research questions. Questions are answered in one day or less.
Clinical research education opportunities View the calendar ofupcoming clinical research education opportunities(VPN).
Required training for first-time principal investigators of interventional trials All first-time principal investigators of interventional trials (drugs, biologics or devices) will be required to complete training prior to release of their study by the IRB. As part of the IRB review process, any first-time principal investigator of an interventional trial will be notified that specific training needs to be completed. Training details are located in the政策文件. For any questions, contact埃里卡·丹霍夫（Erica Denhoff）, ICCTR Clinical Research Education Program Manager.
首次IND和IDE持有人需要培训 All first-time IND and IDE holders will be required to complete training prior to release of their study by the Institutional Review Board (IRB). As part of the IRB review process, any first-time IND or IDE holder will be notified that specific training needs to be completed. Please note that physicians who have only held expanded access INDs for the treatment of an individual patient, under 21 CFR 312.310, are still considered to be first-time IND holders when holding an IND for a clinical trial. Training details are located in the政策文件. For any questions, contact埃里卡·丹霍夫（Erica Denhoff）, ICCTR Clinical Research Education Program Manager.
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