Table 3 National CTIS requirements and related issues
From: Experiences and challenges with the new European Clinical Trials Regulation
Country | Requirement | Issue |
|---|---|---|
Ireland | Searchable documents without signatures (not scanned documents) | Opposite from the requirement in Italy |
Submission of a Data Protection Impact Assessment (DPIA) | Not a pre-defined document, nor has it been requested by other participating countries | |
Italy | Scanned documents with (ink) signatures | Opposite from the requirement in Ireland |
Hungary | Submitted protocol to be signed by all Hungarian investigators. | The submitted version of the protocol will usually be amended during the assessment phase, triggering versioning issues. |
Luxembourg | A copy of the eCRF | Operationally it is more efficient to start the eCRF work after submission. To require a version compatible with the approved protocol while said protocol is subject to change induces versioning issues. |
Luxembourg and Greece | Signed versions of the clinical trial agreements between the sites and the sponsor | This usually requires the agreement to be fully signed and executed. Many countries will not sign a contract before the application is fully approved, which creates a vicious circle of those who do not want to sign a contract before approval and those demanding signed contracts in CTIS. |
Czechia | The full national dossier must be submitted for the transferal application | A clear violation to the requirements set forth in section 11 of the CTR Q&A document. |
Spain | A unique, local version of the Site Suitability document | Will not accept the template developed by the EU Clinical Trials Expert Group endorsed by the EU commission. |