NIH, FDA Release Draft Clinical Trial Protocol Template

The FDA and the National Institutes of Health are seeking comments on a new draft clinical trial protocol template for NIH-funded investigators.

The template is intended to be used for Phase 2 or 3 clinical trial protocols that require IND or IDE applications.

The template was developed to standardize clinical trial protocols to help investigators plan better protocols to avoid trial delays.

The guidance bridges definitions in the ICH E6 Good Clinical Practices guidance and the ISO Clinical Good Clinical Practice guideline (ISO 14155:2011).

Comments on the draft protocol template are being accepted until April 17 at: http://grants.nih.gov/grants/rfi/rfi.cfm?ID=54. — Tamra Sami