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