Adverse events
Adverse events
The Adverse events tab is a feature for clinicians to record any actual or potential medical care, research study or other event causing physical injury. The tab is activated when the patient is officially enrolled in the project, it can show the past adverse events linked to the patient and provide a form where the clinicians can modify or insert a new event, either actual or possible. The clinician are capable of inserting a suspect entity to be associated to this type of event, the suspected entities can be either a device or a medication .
Follow the steps below to insert an adverse event:
- In the patient’s record, click on “Adverse Events” to open the Adverse Events tab
- Click on +ADVERSE EVENT to open the Adverse Event form
- Set the date, the recorded date and the detected date. They are the dates when, respectively, the event has occurred, has been recorded and has been detected
- Click on “Category” and select an option from the dropdown menu. Category is the overall categorization of the event, for instance product-related or situational
- Click on “Event”, and select an option from the dropdown menu
- Click on “Severity”, and select an option from the dropdown menu. Severity refers to the AE intensity
- Click on “Actuality”, and select an option from the dropdown menu. Actuality can be set either as real or potential
- Click on “Seriousness”, and select an option from the dropdown menu. Seriousness is based on patient/event outcome or action criteria
- Click on “Outcome”, and select an option from the dropdown menu
- Click on “Suspected Entity Category”, and select an option from the dropdown menu
- Click on “Suspected Entity”, and select an option from the menu. Only registered devices and medications will appear in the menu
- Click on “Causality”, and select an option from the menu.
- Click on SAVE to save the data, otherwise click on CANCEL to discard them.
