NIH seeks public comment on draft clinical trial protocol template

In an effort to make it easier for investigators to prepare protocols that are consistently organized and contain all the information necessary for the clinical trial to be properly reviewed, the NIH and FDA are developing a template with instructional and sample text for NIH-funded investigators to use in writing protocols for phase 2 or 3 clinical trials that require applications for Investigational New Drugs (INDs) or Investigational Device Exemptions (IDEs). They would like you to weigh in on the template.

Comments on the draft template from investigators, investigator-sponsors, and institutional review board members, and any other stakeholders who are involved in protocol development and review can be submitted here through April 17, 2016. Perspectives on the utility of such a template and whether the instructional and sample text is clear and readable are of particular interest.