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