During interim monitoring, monitors may verify participant rights, well-being, and source data quality. During interim monitoring, monitors may verify participant rights, well-being, and source data quality.
A helpful quality strategy is to document actions and communicate openly with the protocol team. A helpful quality strategy is to document actions and communicate openly with the protocol team.
Quality Assurance is planned and systematic actions to ensure study and data compliance. Quality Assurance is planned and systematic actions to ensure study and data compliance.
The sponsor has ultimate responsibility for implementing and maintaining QA systems. The sponsor has ultimate responsibility for implementing and maintaining QA systems.
Monitors should be appropriately trained and qualified. Monitors should be appropriately trained and qualified.
Research sites may begin recruitment before required approvals and activation are completed. Research sites may begin recruitment before required approvals and activation are completed.
