Study teams’/CRAs’ responsibility is that site team, Principal Investigators, Sub-investigators, coordinators and study nurses are trained and well aware of their responsibilities. Initial protocol or protocol synopsis review are done at very early stage during site feasibility and selection process.
The investigators should be already GCP trained with valid certificates available – if not, Biomapas offers to provide relevant trainings for the study team.
When sites are selected, investigators meeting for training purpose could be organized. During this type of meetings investigators and site staff trained on protocol, specific procedures, specific systems eCRF, IVRS, centralized ECG submissions, laboratory, GCP, safety reporting, IMP handling and other required trainings for the specific clinical trial. More detailed training for site staff is performed during site initiation visit by responsible monitor/CRA. During SIV responsibilities clearly identified and documented. Trainings are provided accordingly and documented on appropriate training log.