Notice Number: NOT-OD-16-043

Key Dates
Release Date: March 17, 2016
Response Date: April 17, 2016

Issued by
National Institutes of Health (NIH)
U.S. Food and Drug Administration (FDA)

Purpose

Background

The National Institutes of Health (NIH) and Food and Drug Administration (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 Investigational New Drug application (IND) or Investigational Device Exemption (IDE) applications. The agencies goal is to encourage and 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 draft template follows the International Conference on Harmonisation (ICH) E6 Good Clinical Practice.

Information Requested

NIH and FDA are seeking public comment on the draft template available at: http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials. We would welcome feedback from investigators, investigator-sponsors, and institutional review board members, and any other stakeholders who are involved in protocol development and review. We are particularly interested perspectives on the utility of such a template and whether the instructional and sample text is clear and readable.

How to Submit a Response

Comments may be submitted at https://grants.nih.gov/grants/rfi/rfi.cfm?ID=54 . Responses will be accepted through April 17, 2016. NIH and FDA will consider public comments before taking next steps

This RFI is for planning purposes only and should not be construed as a solicitation for applications or an obligation on the part of the government. The government will not pay for the preparation of any information submitted or for the government’s use of that information.

The NIH and FDA will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. The information provided will be analyzed, may appear in reports, and may be shared publicly on an NIH website. Based on comments, NIH may consider developing an online, step-by-step protocol template tool to dynamically guide users through steps to write a clinical trial protocol. Respondents are advised that the government is under no obligation to acknowledge receipt of the information or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The government reserves the right to use any non-proprietary technical information in any resultant solicitation(s), policies or procedures.

Inquiries

For questions about this request for comment, email:

SciencePolicy@od.nih.gov