ECGeneralEthicalReview object
Submission for Ethical review mandatory for
All clinical investigations of MD
Submission to CA and EC to be performed in the following order
In parallel
Additional Information
If a clinical investigation does require notification and review, the application may be submitted in parallel with Ethics Committee(s) review.
NB! The final opinion of the Ethics Committee must be submitted to the HPRA prior to the HPRA finalising its review (and prior to commencement of the investigation).
Regulatory and ethics bodies involved in approval process
Competent Authority/-ies (CA)/ For certain types of MDs
Ethics committee(s)
