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EDC import

Pharmacovigilance is a set of activities held to detect, assess, understand, and prevent adverse effects or other drug-related problems. Thus, the object of PV is subject data, mainly—the adverse event (AE) and serious adverse event (SAE) data collected and stored via EDC or external systems.

For PV, to get the data extracted from EDC, the user has to create a task via the EDC > Safety Gateway functionality. When the data is sent from EDC to PV, you receive an email notification and can access the data under the INTAKE > EDC Import tab.

The data flow from EDC to PV is depicted in the following schema.

Data flow from EDC to PV
Figure 1. Data flow from EDC to PV

From the EDC Import page, you can perform the following actions with data imported from EDC:

In this section:

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

An adverse event that results in death, is life-threatening, requires subject hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

Get to know all the possibilities of the app with the comprehensive EDC User Guide.