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Intake management

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 PV, there are three possibilities for data import:

  • EDC import: with this functionality, you can import safety data from the EDC system.

  • E2B R3 import: with this functionality, you can import safety data from the XML file received from your data provider.

  • PDF import: with this functionality, you can import safety data from the PDF file received from your data provider, and the system will transcribe the text within for you.

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.