Clinical Trial Protocol Template Nih

Clinical Trial Protocol Template Nih. Some NIH institutes have a mandatory requirement for using their protocol template. However, site specific information may be provided on separate protocol page(s), or addressed in a separate agreement, and some of the information listed below may be contained in other protocol referenced documents, such.

Clinical trial protocols are critical components of any medical product development program, describing trial objectives, trial design, methodology NIH, which supports and conducts biomedical research, and FDA, which evaluates the safety and effectiveness of medical products and depends on. The draft protocol, developed by the NIH-FDA Joint Leadership Council (JLC), will apply to NIH-funded Phase II and III clinical trials done in support of The new template has the potential to "help clinical investigators make clinical trials more efficient, potentially saving development time and money. The IRB provides several protocol templates on this page.

Guidelines for clinical trial protocol content are available from varied sources, such as textbooks, funding applications and institutional guidelines.

The figure displays the Microsoft Word version of the template, but there is also a markdown version.

Protocol template

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All training must be recorded and records accessible for monitoring, inspection and auditing. The IRB provides several protocol templates on this page. To download this template, you will need access to SharePoint.