Safety Monitoring in Clinical Trials

Safety monitoring is an integral component of clinical trial success. Depending on the nature, size and complexity of each trial, safety monitoring procedures may include anything from IRB approval of an initial Data and Safety Monitoring Plan (DSMP) to creating an overall program with committee oversight. Principal investigators (PIs) are responsible for creating these DSMPs to meet institutional requirements while meeting regulatory agency or study sponsor obligations.

LTIFR (Lost Time Injury Frequency Rate) is one of the key metrics used to gauge workplace safety. As a leading indicator, LTIFR measures an organization's safety management system and shows its overall effectiveness and consistency over time. A lower LTIFR correlates with healthier workforces and increased operational performance.

Inspection and audit completion rates provide an indicator of an organization's dedication to upholding and improving safety standards. By emphasizing this metric, it can promote a culture of responsibility and ownership while fulfilling regulatory requirements.

Addition of lead metrics to your safety metrics set can help avoid future accidents by investigating root causes for incidents and accidents in order to identify areas for improvement. These techniques range from informal interviews and reviewing key work processes and operating disciplines to taking proactive initiatives like proactive inspections or surveys.





Investigations of accidents and incidents should follow established procedures to ensure lessons are learned from them and appropriate steps taken. duress button Focus should be placed on identifying both immediate and underlying causes in order to avoid recurrence of incidents.

Analysis of incident statistics is the key to understanding poor safety performance; however, by the time this information becomes available it's usually too late to take steps that would prevent more accidents from happening. That's why it's vitally important to also utilize lagging safety metrics such as loss time injury frequency rate which measures how frequently someone has been injured at work.

Implementing new safety monitoring metrics into your workplace can be challenging when you don't understand their purpose or results. Alert Alarm With the appropriate digital tools, however, collecting and managing these metrics becomes much simpler as well as streamlining inspections and audits - as well as automatically producing reports and compliance documentation to share with stakeholders and regulatory bodies. If you want more information on improving your safety metrics or need help starting an inspection checklist for all of the key checks and inspections in your facility - contact us! We are more than happy to assist!