ECGeneralEthicalReview object
Submission for Ethical review mandatory for
Clinical IMP trials
Clinical ATMP trials
Submission to CA and EC to be performed in the following order
In parallel
Sequentially (in any order)
Order of submission not defined
Additional Information
Circular 619 (08/04/2015) (french version): Provides a list of Ethics Committees having full accreditation status according to the law dated 7th May 2004 related to experiments on human people.
Regulatory and ethics bodies involved in approval process
Competent Authority/-ies (CA)
Ethics committee(s)
Agency for data protection