Clinical Trial Regulation (CTR) and Medical Device Regulation (MDR) approval

Study details

Snumber

Please fill in the correct Snumber so that the approval can be linked to the correct study. Complete with the 5 digits. Start with S. For example S12345.

Title

Date CTR/MDR approval

Name applicant

Email applicant

Approval

Initial CTR/MDR approval

Transition CTR approval

CTR-scope: based on the approval and the ICF, the biological samples will be used for future research not described in the protocol.

Yes

Biological samples may be used to study another disease, another treatment and another drug than those being tested in the current clinical trial.

Biological samples will only be used for the study of the same disease, the same treatment or the same drug as those being tested in the current clinical trial.

Necessary documents

Only one file can be uploaded per section. If multiple files require uploading, please group them in a single compressed zip file.

Screenshot approval CTIS

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Final approved protocol

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