CATrialAuthorisation object
Regulatory and ethics bodies involved in approval process
Competent Authority/-ies (CA)
Ethics committee(s)
Regulatory and ethics bodies involved - Additional information
national or only institutional approval depends on the participants i.e. whether they are ‘patients’ or recruited from the community
CA - Submission required to
National CA
Institutional CA
Applicable national legal framework/ Reference
whether national or only institutional approval is required, depends on the participants i.e. whether they are ‘patients’ or recruited from the community