• By ICR Secretariat
  • Posted Tuesday, May 9, 2017

FDA, NIH & Industry Advance Templates for Clinical Trial Protocols

http://www.raps.org/Regulatory-Focus/News/2017/05/03/27475/FDA-NIH--Industry-Advance-Templates-for-Clinical-Trial-Protocols/?mc_cid=474ff3f393&mc_eid=%5bUNIQID%5d

The US Food and Drug Administration (FDA) and National Institutes of Health (NIH) on Tuesday released the final version of a common template for clinical trial protocols intended to save sponsors of NIH-funded Phase II and III studies both time and money. It follows from the new ICH GCP E6 revision and covers all the new issues raised.

 

The template, with 60 pages of images and instructions, can be found here.