ECMultiCenterStudiesEthicalReview object

Ethical approval (favourable opinion) required from

Lead EC (authorised to issue a single opinion)

Submission of application required to

Lead EC + All concerned local ECs for site-specific assessment

Additional Information

This competent lead committee depends on the location of the coordinating or principal investigator (“Leiter der klinischen Prüfung”) and is responsible for 'single opinion'. The assessment has to be achieved in cooperation with all ECs which are competent for local study sites (section 8, subsection 5 GCP-V).
The local ECs will evaluate the qualification of the investigators and the suitability of the trial sites. Their opinion should be respected by the coordinating EC. Local ECs can comment on the protocol as well, but the coordinating EC is exclusively responsible for the decision on the content of the single opinion, which it creates independently.
Link to List of ECs: http://www.ak-med-ethik-komm.de/index.php/de/mitglieder

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
Feedback