Research dossier Part I
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.
Please note that all the documents in the clinical trial application should be in a searchable format.