CATrialAuthorisation object

Regulatory and ethics bodies involved in approval process

Medicines Agency
Institutional Competent Authority
Institutional Ethics Committee
Not validated

Regulatory and ethics bodies involved - Additional information

Institutional competent authority is not financially involved in the approval process

CA - Registration requirements for clinical trials

Registration recommended

Registration requirements - Additional information

Registration in EudraCT is not required by law (only generally referred to soft law)
Employees can be required to register clinical trials (eg Medical University of Vienna - Good Scientific Practice)

CA - Submission required to

Institutional CA