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View safety data

In PV, you can view the safety data on AE/SAE from EDC that has already been reviewed and imported into the system as an ICSR report. The View feature serves auditing purposes if you need to check something without performing any additional actions.

To view the safety data

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

    Accessing intake management
    Figure 1. Accessing intake management

  2. On the page that opens, in the left pane, select the EDC Import subtab.

  3. In the EDC Import List that appears, locate the reviewed safety data for which you need to view the details. Then in the Actions column next to it, select View info_icon.png.

    Selecting to view safety data
    Figure 2. Selecting to view safety data

    Tip

    You can only see the cases based on the study access permission granted via ADMIN.

    To locate the needed safety data faster, filter the table by study name, site code, subject ID, or other parameters.

  4. On the page that opens, in the left pane, navigate between subtabs to view the details of your interest.

    Viewing safety data
    Figure 3. Viewing safety data

  5. Select cancel_button.png to close the safety data details and return to EDC Import List.

Upon closing, you have viewed the safety data. You can also compare the initial and follow-up data, if any.

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.

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.

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.