While procedures, checklists, guidance documents, report templates and all sorts of other things combine to form the infrastructure for monitoring, what is possibly even more important is the shared mindset—the acceptance by all that, regardless of one's title, there is a shared responsibility in calling out issues, in looking purposefully at this document, in questioning that blank.
The purpose of clinical trial monitoring can be summed up as follows:
- To ensure
protectionof the rights and well-being of study subjects
- To ensure data integrity
- To ensure compliance with federal regulations, agreements, clinical investigational plan and the requirements of the IRB
- To identify and address non-compliance
- To improve quality and promote high standards
- To identify research misconduct and fraud
The empowerment of others to assume the role of monitor every day they come to work, in whatever capacity that is, will achieve the desired goals—protected patients, compliance, and quality. To monitor is more than a title. It is a mindset.
Please take time to download Monitoring as a Mindset and feel free to share your thoughts.