When the EU Clinical Trials Regulation (CTR, EU No 536/2024) on medicinal products for human use became applicable, it changed the way clinical trial applications (CTAs) are submitted. Since 31.1.2023, it has been mandatory to submit all initial clinical trial applications via the Clinical Trials Information System (CTIS) portal.
The CTIS portal brings new responsibilities and requirements and raises questions. We created a practical guide on how to successfully submit your clinical trial applications. The information is especially targeted at academic researchers conducting clinical trials in Finland.
The guide briefly covers the following topics:
- CTIS portal
- EMA system registrations & activations
- Submission procedure
- Required data and documents
- Requests for information (RFIs) in CTIS
- Substantial modifications in CTIS
- Product management in CTIS
- Notifications in CTIS
- Safety reporting in CTIS
- Public website and transparency
You can read the guide right away after your order.
We are happy to help with CTIS submissions
The CTIS promotes collaboration and communication between stakeholders involved in the clinical trial approval process, helping to ensure a more consistent and timely review of applications. At the same time, the CTIS portal brings new responsibilities and requirements also for investigators. If you’re not sure how to get started, or you need help with specific parts, Medfiles’ Clinical Team is happy to give you practical and tailored guidance and support throughout your clinical trial submission process.
