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