ECSingleCenterStudiesEthicalReview object

Ethical approval (favourable opinion) to be obtained from

Local EC linked to the trial site

Additional Information

The opinion has to be issued by an EC with full accreditation status (Apr 2014- Apr 2018: n=24 - Status 2015)

If the EC linked to the site has not been awarded full accreditation, but only partial accreditation status, the sponsor of the research project designates a committee with the required status to be authorized to issue a single opinion.
The EC with partial accreditation, linked to the site where the study will be conducted, should issue an opinion on the competencies of the researcher, the appropriateness of the facility and the adequacy and completeness of the patient information materials.