Can somebody inform me as to whether an ethics committe approval is required for a diagnostic testing site? The company I work for only perform a testing service for the Sponsor conducting a phase III clinical study. We have no patient interaction and satisfy all patient confidentiality and identity requirements as part of the service we provide. All GCP requirements between ourselves and the Sponsor are agreed and documented in the Analytical Plan (i.e. sample management, informed consent etc)

Thanks
Adnaan