FDA Reports Release of Final Template for Clinical Trial Protocols

According to FDA on May 2, “A little more than a year ago, FDA and NIH announced the availability of a draft template for investigators to use when organizing clinical trial protocols, which are essentially road maps for conducting a clinical trial. Today, we are excited to announce that the NIH-FDA Joint Leadership Council has issued a final version of the template, a development which is likely to contribute important efficiencies to the process of protocol development, saving medical product development time and money. The final version is intended for clinical investigators who are writing protocols for phase 2 and phase 3 NIH-funded studies requiring investigational new drug or investigational device exemption applications, but could also be helpful to other investigators conducting studies of medical products that are not regulated by FDA.”

Here are links to the full story as reported by FDA, a story on the topic from RAPS Regulatory Focus, a link to the template, which follows International Conference on Harmonisation (ICH) E6 (R2) Good Clinical Practice guideline and includes instructions, explanatory text and samples, and a link to contact PDG for help designing your clinical or PK/PD study.