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PV integration with EDC

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.

In eClinical, the PV application is fully integrated with EDC through the Safety Gateway feature of EDC.

With Safety Gateway, you can extract CRF data according to sponsor requirements and send them to PV. An EDETEK administrator completes the data extraction configuration according to the annotated CRF, in which customers can flag the data required for extraction and discuss the details with the relevant specialists.

Configuring Safety Gateway for data extraction
Figure 1. Configuring Safety Gateway for data extraction

Important

The configuration process requires familiarity with EDC and PV data structures and partial programming. Thus, it is better to be configured by the EDETEK administrator.

Nevertheless, if the function is used frequently enough and the customer is willing to configure it, it may also be open to the customer to configure himself.

Once the EDETEK administrator has configured the required data extraction settings, you can proceed to task management.

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.