Insights

Article 11 of Regulation (EU) No 536/2014 allows sponsors to submit an initial clinical trial application to a Member State Concerned with Part I only, postponing the submission of the complete Part II dossier.

In practice, however, CTIS limitations may prevent Part I-only Member States from participating in subsequent Part I substantial modifications and may also affect applications involving additional Member States.

The CTCG workaround addresses this issue by allowing sponsors to submit the complete Part I dossier together with placeholder Part II information and documents. The cover letter must clearly identify which Member States receive a full application and which are intended to remain Part I only. Hybrid submissions containing partial actual Part II information are not accepted.

Part I-only Member States can therefore remain involved in the coordinated assessment of later Part I substantial modifications. Nevertheless, the clinical trial cannot start, and participants cannot be recruited in those countries, until the complete Part II dossier has been submitted and authorized through subsequent substantial modification.

Sponsors must also follow specific CTIS requirements for placeholder trial sites, investigator details and mandatory documents. Once the actual Part II dossier is submitted, all placeholder information must be replaced with complete and updated documentation.

This approach supports greater flexibility in multinational clinical trial planning while maintaining participant protection, regulatory oversight and data reliability.

RPN will provide any further updates and is available to provide full support for CTIS and clinical trial activities.