Structure research dossier in CTIS

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.

The documents in the clinical trial application should be in a searchable format.

Furthermore, it is strongly recommended to adhere to the structure of CTR Annex I when titling your documents in CTIS. Please use the codes and filenames as given in the Instruction on uploading, naming and changing documents in CTIS. This instruction also specifies how to change your clinical trial application in CTIS if an RFI requests new documents or document changes.

Explanatory notes and templates (including national requirements) are given in the sections Form and MSC, 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.