Glossary Term
Monitoring Plan
Definition
A monitoring plan is a documented strategy outlining the processes, responsibilities, and methodologies for systematically overseeing clinical trials, medical device performance, or post-market activities. It ensures that the collected data is accurate, the trial or device complies with regulatory requirements, and that patient safety is prioritized.
Relevance to the MedTech Industry
Monitoring plans are critical for ensuring compliance with Good Clinical Practices (GCP), ISO 14155 for clinical investigations of medical devices, and other regulatory standards. They provide a framework for identifying and mitigating risks, maintaining data integrity, and protecting patient safety throughout the device lifecycle.
Additional Information & Related Terms
Key Components of a Monitoring Plan
Objectives and Scope:
Clearly define the purpose of monitoring and the activities it will cover, such as clinical trials or post-market surveillance.
Roles and Responsibilities:
Specify the duties of the monitoring team, including clinical monitors, investigators, and site staff.
Risk Assessment:
Identify potential risks related to study conduct, data collection, and patient safety, and define mitigation strategies.
Monitoring Methodology:
Outline the approach, such as on-site visits, remote monitoring, or centralized data review.
Frequency of Monitoring Activities:
Determine how often monitoring will occur, based on study complexity, site performance, and regulatory requirements.
Data Review and Verification:
Describe how data will be assessed for accuracy, completeness, and compliance with the protocol.
Issue Resolution:
Define processes for identifying, documenting, and resolving deviations, risks, or non-compliance.
Documentation and Reporting:
Specify the format and content of monitoring reports and how findings will be communicated.
Related Terms
Risk-Based Monitoring (RBM): A methodology that focuses resources on high-risk areas of clinical trials.
Good Clinical Practices (GCP): International ethical and scientific quality standards for designing, conducting, and reporting clinical trials.
Post-Market Surveillance (PMS): The process of monitoring device performance after market approval.
Site Monitoring Visit (SMV): A physical or virtual visit to review clinical trial conduct and compliance at a study site.
Adverse Event Reporting: Documenting and assessing unexpected or undesirable effects during trials or post-market use.