Protocol-specific, not generic
Training is built around this study's actual procedures, not a standing GCP module reused across unrelated protocols.
What's included
What the training covers
- Protocol walkthrough covering visit schedule, inclusion/exclusion criteria, and study-specific procedures
- eCRF and source document completion training, matched to the study's actual data collection instruments
- Investigational product handling, dosing, and accountability procedures specific to the protocol
- Adverse event identification and reporting requirements as defined for this study
- Documented attendance and competency confirmation for every site role and assigned CRA
- Training records filed as essential documents, ready for review at the Site Initiation Visit
Confirmed before enrollment
Completed training is one of the gates checked at the Site Initiation Visit, so no site opens with an untrained team.