CATrialAuthorisation object

Regulatory and ethics bodies involved in approval process

Competent Authority/-ies (CA)
Ethics committee(s)

CA - Submission for authorisation mandatory for

Clinical IMP trials
Clinical ATMP trials

CA - Submission required to

National CA

National trial registry - Registration mandatory

Yes

Additional Information

For national registration, contact the responsible person at Health Trust. Trials shall be published on the Health Trust's website. Registration at clinicaltrials.gov may be a requirement for publication in certain journals.

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