Before the study starts everyone involved in the conduct of clinical research must have updated and adequate CVs and training to ensure they are well experienced in clinical trials and are aware of their responsibilities. It is required evidence of attendance/certification at a recognised Good Clinical Practice (GCP) training course for clinical trials, updated every 2 years, or after major changes in clinical trial legislation (whichever occurs first). Evidence of valid GCP training for any member of the site staff involved in the study shall be checked before the beginning of the study. If no valid evidence is available. GCP training shall be checked during monitoring visits to ensure that it is kept up-to-date.
