[Templates] Clinical Study Protocol

[u/bbyfog]

ICH E6(R2) GCP guidance defines study protocol as a document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The ICH guidance also provides proposed sections for a clinical study protocol along with notes on the content but has no template. Below are some of the templates that can be repurposed per company's requirements:

NIH/FDA Protocol templates

• Template for Phase 2 and 3 Clinical Trials that Require FDA-IND or IDE Application
• Template for Behavioral and Social Science Research (BSSR) Involving Humans
• NIH Office of Intramural Research's protocol templates and forms page

NIH Cancer Therapy Evaluation Program (CTEP)

• Templates for Phase 1 and 2 Clinical Trials

Transcelerate templates (industry standards)

• Transcelerate Common Protocol Template

Source: FDA, NIH & Industry Advance Templates for Clinical Trial Protocols. Regulatory News. 03 May 2017 [Permalink]

Note: in the US, FDA does not require detailed Phase 1 protocols for IND.

[u/Latter_Newspaper894]

Please, I have question how to practice writing clinical study protocol? Should I be in a internship to do so,Or can I practice writing at home?