Monitoring skills and responsibilities required of the CRM were covered in this course, including site initiation, routine monitoring, critiquing case report forms, writing an effective corrective action plan, writing a monitoring report, and designing a process for source document verification in accordance with Good Clinical Practice.
- Differentiate the role of the clinical research monitor from other clinical research professionals.
- Critique case report form design in meeting its study purpose.
- Organize a study initiation visit including study roles and responsibilities.
- Write an effective corrective and preventive action plan (CAPA).
- Define source data review including source data, verification of source data, and review of data to ensure compliance with protocol, good clinical practices (GCP) and regulations.
- Compare and contrast central monitoring, risk-based monitoring (RBM), and associated monitoring analytics.
- Compare and contrast monitoring visits versus audits and FDA inspections.