ECMultiCenterStudiesEthicalReview object
Lead EC + All concerned local ECs for site-specific assessment
Lead EC (authorised to issue a single opinion)
The sponsor of a trial is responsible for selecting a national coordinator among the investigators involved in the multicentre study in Poland.
The sponsor or the designated coordinator must submit the application of a clinical trial to his or her local EC (“Bioethics Committee”) depending on the coordinating investigator office location.
According to the Art 37s Pharmaceutical Law 2001, the coordinating EC, acting as the “lead” EC, informs all other relevant ECs for the sites involved in the multicentre trial.. All local ECs have up to 14 days to submit any concerns about participation of an investigator or a site in the clinical trial.
If the coordinating EC does not receive any concerns from the local ECs within this time limit, then its opinion is accepted for all the sites in the country.