Monitoring Plan

A monitoring plan is a structured framework established to oversee and manage the conduct of the study. It comprises a set of procedures, guidelines, and methodologies to systematically evaluate and supervise various aspects of the trial. The key components of a monitoring plan include:

Site Visits: Regular on-site visits by clinical research associates (CRAs) to evaluate the site’s compliance with the protocol, patient safety, and the accuracy of data collection.

Data Review: Scrutiny of collected data to verify its accuracy, consistency, and completeness. This involves comparing source documents with the data entered into the case report forms.

Adherence to Protocols: Ensuring that the trial is being conducted in accordance with the approved protocol, the correct administration of investigational products and the proper conduct of study procedures.

Regulatory Compliance: Confirming that the trial adheres to regulatory requirements, ethics committee approvals, and Good Clinical Practice (GCP) guidelines.

Quality Control: Assessing the overall quality of the trial, including the quality of data collection, investigational product handling, and documentation.

Risk Assessment: Identifying potential risks and issues that could affect patient safety or data integrity, and taking appropriate corrective actions.

Reporting: Documenting findings and reporting them to all stakeholders.