Compiling research dossier: general information

The application dossier consist of a Part I and a Part II. The list of required documentation and information is set out in Annex I of the CTR.

Explanatory notes and templates (including national requirements) are given in the sections Research dossier part I and Research dossier part II.

See EMA CTIS training module 10 on how to create, submit and withdraw a clinical trial.