Clinical Research Monitoring

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.

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