Highlights
- In the Netherlands, clinical studies using (specialised) medicinal products must be approved by a certified ethics committee.
- CHDR develops the study protocol, submits it to a certified ethics committee and the competent authority, and communicates with the Dutch regulatory bodies.
- CHDR has an established working relationship with several ethics committees.
- If desired by the sponsor, CHDR can also serve as a legal representative within the EU.
- In most cases, approval can be obtained within six weeks of submitting the application.
Summary
As part of CHDR’s full service offering, we can handle protocol development, set-up and guidance for the new EU Clinical Trial Regulation (EU-CTR), compilation of a CTR submission dossier and the regulatory submission via the European Clinical Trials Information System (CTIS).
The protocol, trial documents and the Clinical Trial Application (CTA) are submitted via CTIS, an EU portal. The application is first validated by the competent authority (the CCMO) and subsequently assessed by an accredited ethics committee. All the while CHDR will be in communication with the National regulatory authorities concerned with the validation and assessment of the dossier.
Timelines
Our timelines typically look as follows:
