NIH and the Food and Drug Administration (FDA) have created a template to help facilitate the FDA review process for NIH-funded clinical trial protocols. The template is initially aimed at Phase 2 and 3 Investigational New Drug (IND)/Investigational Device Exemption (IDE) protocols and meets International Council for Harmonisation E6 (R2) Good Clinical Practice Guidance. The template also helps investigators prepare protocols that contain all the information necessary to enable efficient and timely review by Institutional Review Boards (IRB) as well as comply with FDA regulations.
Having a common template format with tailored instructions that fit each sectors’ needs will further facilitate FDA review and help increase the efficiency of the clinical trial enterprise. Along with the narrative version of the final template, NIH will also make available an electronic protocol writing tool to guide protocol writers through the required protocol sections and facilitate a collaborative approach to writing and reviewing protocols.
Read the NIH press release here.
Access the tool here.