Research dossier Part I consists of sections B-J of Annex I of the CTR and is the same for all member states concerned. The section characters B-J are not visible in CTIS. Instead there are several placeholders to complete the sections with trial and document identifiers and to upload the requested documents.
On the pages below, the layout of the Part I application in CTIS is explained and an overview is given of the documents to be submitted.
Make sure that all submitted documents are in searchable format.
A Dutch translation should be entered for the following fields in Part I: the full and public study title (section Trial Identifiers), and the Medical condition, Main/Secondary Objectives, Inclusion/Exclusion criteria and Primary/Secondary Endpoints (section Trial Information).