A one day course aimed at investigators, project managers and associated research team members involved in investigator-led clinical trials, representatives from the pharmaceutical industry and research officers from academic institutions. This course incorporates the Integrated Addendum to ICH GCP Guideline E6 (R2) adopted by the EMA in December 2016.

Please contact either:

Deirdre Hyland: Senior Research Nurse/Director of Research Nurse Education (01) 809 3785 dhyland@rcsi.ie or

Carole Schilling: Senior Research Nurse/ Quality & Regulatory Affairs Manager (01) 809 3789 caroleschilling@rcsi.ie

Downloadable Content:
GOOD CLINICAL PRACTICE: SPONSOR RESPONSIBILITIES – INCORPORATING INTEGRATED ADDENDUMS (E6R2) (PDF)