Clinical trials are intense, and researchers are constantly on their toes performing all the functions, collecting data, communications, and reporting. Despite the busy schedules and planning, no clinical trial can happen without appropriate patient safety measures.
Most patient-related trials involve testing, which means there are new pharmacological agents and medical equipment around when the tests are happening. People participating in clinical trials would be far less forthcoming about the process if protective measures were not in place.
However, that’s not the only reason for having a patient safety and monitoring plan.
What Is SAE Monitoring?
SAE stands for Serious Adverse Event; therefore, SAE monitoring refers to monitoring an adverse contingency during the trial. Some examples of SAE are as follows:
- Trial events affecting a patient’s health adversely, leading to permanent disability.
- Clinical trial participation causing dangerous complications for patients or participants.
- A patient dying during a clinical trial.
- Events within clinical trials that are deemed hazardous for patients by investigators.
The events mentioned above are only some that count as SAE, and all circumstances require a concrete plan to manage the situation.
Why Is It Important to Have a Patient Safety and SAE Monitoring Plan?
Having proper patient safety and SAE monitoring plan in place is a good measure due to several reasons. Here’s why we always recommend it.
1. Reduces Risk of Fatalities
Having a formal plan in place will reduce the risk of a clinical trial problem becoming fatal for the patient. The timely triggering of an alarm system will alert researchers about the changing situation and prevent deaths.
2. Mitigates Health Hazards
By working with a formal plan during a clinical trial, most researchers can prevent a health hazard from happening or can mitigate its impact.
3. Prevents Panic
Knowledge of adverse effects of chemicals, medications, or procedures during the trial will spread unnecessary panic among patients unless the trial has a containment plan in place. Panicking worsens the situation, which is why following safety SOPs is the best method.
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