Skip to content

Menu

LexBlog, Inc. logo
CommunitySub-MenuPublishersChannelsProductsSub-MenuBlog ProBlog PlusBlog PremierMicrositeSyndication PortalsAboutContactResourcesSubscribeSupport
Join
Search
Close

NIH and FDA Announce Release of Draft Clinical Trial Protocol Template; Call for Comments by April 17, 2016

By Robert Church, Mike Druckman, William F. Ferreira & Katelyn Ruiz on March 28, 2016
Email this postTweet this postLike this postShare this post on LinkedIn

The National Institutes of Health (NIH) and Food and Drug Administration (FDA) announced on March 17, 2016, their co-development of a draft clinical trial protocol template for use by NIH-funded investigators.  The template is meant for use in writing phase 2 or 3 clinical trial protocols where Investigational New Drug application (IND) or Investigational Device Exemption (IDE) applications are required.

The template provides instructions and sample text that are intended to facilitate the preparation of consistent, organized, and complete protocols, so that clinical trials can be properly and more efficiently reviewed by the agencies.  The template protocol follows the International Conference on Harmonisation E6 Good Clinical Practice guidance.

NIH and FDA request public comment on the draft template from investigators, investigator-sponsors, institutional review board members, and any other stakeholders involved in protocol development and review.  The agencies are particularly interested in the utility of the template and the readability and clarity of the instructional and sample text.  Comments will be accepted through April 17, 2016, but the announcement notes that comments will be used at the agencies’ discretion and responses to comments will not be provided.  Draft template documents can be found here, and responses may be made here.

If you have any questions about the request for public comment from the NIH and FDA, please feel free to contact one of the Hogan Lovells authors of this blog post.

  • Posted in:
    Administrative
  • Blog:
    Focus on Regulation
  • Organization:
    Hogan Lovells
  • Article: View Original Source

LexBlog, Inc. logo
Facebook LinkedIn Twitter RSS
Real Lawyers
99 Park Row
  • About LexBlog
  • Careers
  • Press
  • Contact LexBlog
  • Privacy Policy
  • Editorial Policy
  • Disclaimer
  • Terms of Service
  • RSS Terms of Service
  • Products
  • Blog Pro
  • Blog Plus
  • Blog Premier
  • Microsite
  • Syndication Portals
  • LexBlog Community
  • 1-800-913-0988
  • Submit a Request
  • Support Center
  • System Status
  • Resource Center

New to the Network

  • The FTI Award Journal
  • International Dispute Resolution
  • China Law Update Blog
  • Law of The Ledger
  • Antitrust Law Blog
Copyright © 2022, LexBlog, Inc. All Rights Reserved.
Law blog design & platform by LexBlog LexBlog Logo