ECGeneralEthicalReview object
Submission for Ethical review mandatory for
Interventional MD investigations
Observational MD investigations
Submission to CA and EC to be performed in the following order
In parallel
Sequentially (in any order)
Additional Information
According to the law, submission to the EC and CA can be done in any order or simultaneously, depending on the sponsor’s preference (pursuant to Art 15 Circular 7/2004)
NB! Approval by the EC is a necessary requirement for CA authorization!
Regulatory and ethics bodies involved in approval process
Competent Authority/-ies (CA)/ For certain types of MDs
Ethics committee(s)
