Thursday, May 04, 2017

Final Version of Protocol Template by FDA/NIH and TransCelerate

Previously, I discussed the protocol template for clinical trials. This week, FDA/NIH and TransCelerate simultaneously released the final version of the protocol template.

FDA/NIH's protocol template is intended for clinical investigators who are writing protocols for phase 2 and phase 3 NIH-funded studies requiring investigational new drug (IND) or investigational device exemption (IDE)  applications, but could also be helpful to other investigators conducting studies of medical products that are not regulated by FDA.

The final protocol template by TransCelerate is for industry-sponsored clinical trials for the licensure.

                            Word Version of Final Template

                            Common Protocol Template Core Template – Basic Word Edition
                            Common Protocol Template – Technology-Enabled Edition

REFERENCE: FDA, NIH & Industry Advance Templates forClinical Trial Protocols | RAPS

1 comment:

neena said...

thank u for sharing good info !