Patient Safety & Serious Adverse Event Monitoring

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Your patient registry initiative should require a Patient Safety and Monitoring Plan (PSMP). A PSMP describes how the study investigators will oversee patient safety and how adverse events will be graded, characterized, and reported. The plan should be tailored to fit each study.

A simple plan may be adequate for a minimal risk study; a more detailed plan will be required for above minimal risk studies. The Principal Investigators (PIs), who have primary responsibility for patient safety and who will be tasked with entering patient data directly into your patient registry software system, should be asked to submit this information in a separate section to the study sponsor and the FDA.

Promoting patient safety is a national priority. To evaluate interventions for reducing medical errors and adverse events, effective methods for detecting such events are required. It's important that your organization has a cognitive framework for error monitoring and detection.

While manual chart review has been considered the "gold-standard" for identifying adverse events in many patient safety studies, this methodology tends to be very expensive, labor intensive and imperfect.

Investigators have developed or are currently utilizing electronic medical data capture or patient registry software systems that can record, track and monitor serious adverse events using free-text clinical narratives, coded data, pre-formatted FDA specific CRF's... or a combination of techniques.

There have been advances in these systems with regards to HIPAA compliance, security and safety checking. These systems include email notifications to sponsors and medical affairs/regulatory groups - the instant a serious adverse event is recorded in a registry system that can greatly facilitate your ability to monitor adverse events and promote patient safety research.

Your patient safety and serious adverse event monitoring methodology should be:

	Customized to fit your parameters
	Easy to navigate
	Allow for current and ongoing monitoring by individual SAE
	Secure, HIPAA compliant, private
	Able to be tracked
	Include robust reporting
	Able to issue / auto-email instant updates in real-time
	Can track and monitor multiple SAE potential sources