Key Principles of Monitoring

Ensuring clinical trial subjects are safe and rights are protected.
Ensuring data integrity.
Ensuring clinical trial is conducted according to the investigational plan.
Ensuring opportunities to improve the clinical trial conduct and oversight are identified, communicated, and documented.

CRSC Monitor Responsibilities

CRSC Supports Sponsor Oversight and Management of the Clinical Trials by Adhering to Monitor Responsibilities to:

Ensure Compliance: Make sure the trial adheres to regulations and guidelines, such as Good Clinical Practice (GCP), US FDA regulations, and local guidelines .
Protect Subjects: Ensure the rights and well-being of subjects are protected. 
Verify Study Source Data: Ensure that data is accurate, complete, and verifiable. 
Document Monitoring Findings and Action items: Document the results of monitoring visits in monitoring visit reports according to the monitoring plan for sponsor review and awareness.
Monitor Clinical Trial Risks:  Identify potential risks to study conduct, patient safety, and data integrity .
Assist with Clinical Trial Preparation: Help sponsors and investigator sites prepare study-specific documents, including but not limited to adverse event logs, informed consent forms, source document templates.
Manage Essential Documents: Review and/or collect essential documents prepared by the site staff for filing the Trial Master File (TMF) and Investigator Site File (ISF).
Maintain Communication: Communicate with study site personnel, Principal Investigators, and other members of the sponsor team .