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ICSR management

The individual case safety report (ICSR) is a safety service document that includes information required to report the AE/SAE data and problems related to products and consumer complaints about any product. The data transformation process from an AE/SAE record in EDC to an ICSR report in PV that is ready for submission to regulatory authorities/third parties can be depicted as follows.

AE/SAE data transformation into ICSR
Figure 1. AE/SAE data transformation into ICSR

In PV, to create the ICSR, the safety data on occurred AE/SAE is extracted from EDC via data extraction task management or can be imported from E2B R3-compliant XML. As soon as the extracted data lands in PV, it must be reviewed and thus transformed into an ICSR, as follows:

  • An initial ICSR if this is the first time the case is reported.

  • A follow-up ICSR—if the data is an updated version of the previously reported case.

Important

In PV, you can also create an ICSR from scratch and manually add the required data to the forms.

Once the new ICSR is created in PV, the assigned user(s) receives an email notification with the respective details, such as a case number with which they can find the report in the ICSR List in PV to review and further manage it to prepare for submission to regulatory authorities.

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.

sponsor'sE2B (R3)EDCpreferred termsdata sheetadverse event (AE)adverse event (AE)ICH E2B(R3ICH E2B(R3)adverse eventssponsor'sThe field can be optional or mandatory depending on the status configuration to which you are forwarding the route.