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 an 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 the FDA.

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

• FDA/NIH protocol template (final)

                            Word Version of Final Template

• TransCelerate protocol template (final)

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


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