Monitoring remains our main focus at IMARC Research. As discussed in a previous whitepaper, “Monitoring as a Mindset”, monitoring is defined by the FDA as the act of overseeing an investigation. Specifically noted in 21 CFR 812.43, sponsors are required to select monitors qualified by training and experience. In addition, 812.46 states that monitoring investigations should include securing compliance at investigative sites, whenever necessary.
As always, we keep the requirements of the federal regulations in mind. We know from the regulations, such as those listed above, that the intention of clinical trial monitoring is to protect the rights and well-being of study subjects, ensure data-integrity, and ensure that the trial conduct is in compliance with the clinical investigation plan (CIP), agreements, GCP, requirements of the Institutional Review Board (IRB)/Ethics Committee (EC), and all applicable regulations. In addition, the goals of monitoring should include identifying and addressing non-compliance; improving quality and promoting high standards; and identifying research misconduct or fraud.
We believe monitoring matters and have created a whitepaper outlining 5 steps that can be taken to ensure monitoring goals are achieved. They are as follows:
- Identify Quality Monitors
- Develop a Monitoring Plan
- Perform Monitor Training to Ensure Proper Execution
- Identify and Document Findings
- Secure Compliance
The importance of the monitoring function in clinical trials cannot be underestimated. The end-goal is to ensure a well-controlled, compliant clinical study in which human subjects are protected and the resulting data is evaluable. Achieving this goal takes diligent efforts on the part of sponsors, monitors and investigational site staff, working together as a study team.
In taking the five steps for monitoring outlined above, sponsors may avoid costly clean-up efforts, prevent a warning letter, ensure that data is credible and reliable, and ensure that all human subjects were protected throughout the process. Monitoring definitely matters!
Please take time to download IMARC’s whitepaper and provide us with your thoughts.