Information form clinical trials (Clinical Trials Regulation (CTR)
Information form clinical investigations/performance studies (MDR/IVDR)
Information form future research (CTR/MDR/IVDR)
Information form minors under 12y (CTR)
Information form minors 12-15y (CTR)
This information form is only to be used in studies involving emergency situations as described in CTR Article 35 (3), MDR Article 68 (3) or IVDR Article 64 (3):
Information form, right to reservation of use of data (CTR, MDR, IVDR)
English:
- The necessary information letter with a request for participation and a declaration of consent in accordance with a template shall be prepared as an appendix to the application.
- Click on the link below to download the template and save it on your own computer for further editing.
- After editing, the information letter must be uploaded as an attachment to the application form.
Template – Informed Consent Form Clinical Trials Regulation (CTR)
