ECMultiCenterStudiesEthicalReview object

Ethical approval (favourable opinion) required from

Recognised EC (authorised to issue a single opinion)

Submission of application required to

Recognised EC (authorised to issue a single opinion)

Additional Information

Only one application for an EC’s opinion (regardless of the number of trial sites at which the trial is to be conducted) shall be submitted to the relevant EC which has been recognised by the ECSB(Ethics Committe Supervisory Body/Minister of Health) for the whole state, the part of the state or a particular institution or group of institutions in which the Chief investigator is professionally based. (Regulation 12 SI 190/2004)

A Site Specific Assessment (SSA) should be performed at each participating trial site in Ireland. The standard SSA form (Form 3) to be used shall be completed by the Investigator at each site and forwarded to the Chief Investigator. The Chief Investigator should submit all SSAs to the Recognised Ethics Committee. Form 3 is available on the Department of Health website in section: Clinical Trials involving Medicinal Products >Application Forms.

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