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The Behavioral and Social Clinical Trials Template

October 21, 2018 By Template.info

In May 2017, NIH and FDA released the final version of a template document aimed at assisting NIH-funded investigators in preparing Phase 2 and 3 IND/IDE clinical trial protocols. This template was created to guide investigators through the systematic development of a comprehensive clinical protocol. The template will be especially helpful to investigators who are less familiar with the information and the level of detail that is required in a clinical protocol. The template retains much of the content and structure of the NIH-FDA Phase 2 and 3 IND/IDE clinical trial protocol template but has been tailored specifically for studies involving a social or behavioral intervention. Given the variations of intervention approaches and designs in the behavioral and social sciences, the NIH wants to encourage comments from a broad and diverse range of investigators on this draft protocol template.

The Behavioral and Social Clinical Trials Template

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