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Create ICSR from scratch

In PV, you can create an ICSR based on the safety data pulled from EDC via data extraction task management, by copying an existing ICSR, or by uploading an XML file. You can also create a report from scratch and insert all the required data manually, for instance, if the information is taken from a paper form.

To create an ICSR from scratch

  1. In the PV application header, select the ICSR tab.

  2. On the ICSR List page that opens, from the workspace toolbar, select New add_new_icon.png.

  3. On the page that opens, fill in the details of the following forms:

    Creating ICSR from scratch
    Figure 1. Creating ICSR from scratch

    Tip

    To facilitate the form completion, enable Help help_icon.png. When enabled, the Help panel opens, showing the tips on the selected field completion according to regulatory or other requirements.

    Enabling help to view tips on field completion
    Figure 2. Enabling help to view tips on field completion

    To close the panel, select Help help_icon_red.png.

In this section:

A safety service document that includes information required for reporting the adverse events and problems related to products and complaints filed by consumers with respect to any product.

In Pharmacovigilance, all the data on adverse events and other occurrences related or suspected to be related to investigational products. In eClinical, it is mostly data collected from subjects during clinical trials; this data helps to evaluate product safety and efficacy.

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.

The FDA's Safety Information and Adverse Event Reporting Program that interacts with the FDA Adverse Event Reporting System (FAERS or AERS). MedWatch is used for reporting an adverse event or sentinel event.