Clinical Trial Monitoring

Clinical trial monitoring is an integral part of Good Clinical Practices. The purposes of clinical trial monitoring are to verify that:

1. The rights and well-being of human subjects are protected.
2. The reported trial data are accurate, complete, and verifiable from source documents.
3. The conduct of the trial is in compliance with the protocol, GCP, and regulatory requirements

The clinical trial sponsor should ensure that trial are adequately monitored and also extent and nature of the monitoring.

Purpose of Data Monitoring

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Reviewing clinical trial data is necessary to ensure that:

• Participants are safe
• The trial is credible
• Data is valid

Purpose of Safety Monitoring Plan

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The safety monitoring plan ensures the safety of the participants to the greatest extent possible. It also helps:

• Plan the on-going oversight and monitoring of the conduct of the study to ensure the validity and integrity of the data produced.
• Document the conditions and monitoring frequency regarding the decision as to whether or not the study should continue or be stopped.
• Specify the responsibilities (charter) of the DSMB (Data and Safety Monitoring Board) - if a DSMB is required or a TEC (Treatment Effects Committee).

What should a Data and Safety Monitoring Plan include?

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A Data and Safety Monitoring Plan should include the following:

• Who is responsible for monitoring
• What data is being monitored consistent with the protocol
• What process is being used to collect data in the monitoring process
• The Adverse Event and Serious Adverse Event (AE & SAE) monitoring plan is to be clearly outlined
• Characteristics of the trial subject population
• The safety endpoints and how they are assessed
• Listing of expected Events / background AEs
• Who reviews the Safety Data
• Criteria for study discontinuation
• Need, or not, for a DSMB
• Identity of the Medical Monitor (if there is one)

ComplianceOnline training on clinical trial monitoring

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Data Monitoring Committees (DMCs) in Clinical Research - its effect on subject public safety and how can it be effectively set up

This Data Monitoring Committees (DMCs) training for Clinical Research teaches why the increase in using Data Monitoring Committees (DMCs) in Clinical Research affects Subject-public Safety.

What is the role of Data and Safety Monitoring in Clinical Research Involving Human Subjects - When and How?

This Clinical Research training guides you through Data and Safety monitoring plan and why Data and Safety monitoring is essential in Clinical Research Involving Human Subjects.

Clinical Trials Audit Proof Monitoring Programs

This training teaches how to identify gaps, risks in relation to preparation of regulatory inspections of sponsor monitoring programs by understanding of components of a quality monitoring system.

Enhanced Monitoring Practices and Techniques That Ensures FDA Compliance

This training guides you through enhanced techniques to optimize productivity without compromising subject safety and quality data in clinical monitoring for US- based premarket trials.

Auditing vs. monitoring, defining the purpose, application and process

This Clinical Trial audit training teaches risk-based approach to the process of monitoring and auditing clinical trial.