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Search for ICSRs

In PV, you can use simple search or advanced filters to find the needed ICSRs in the list. While the objective of both simple and advanced search is to locate the cases of your interest quicker, however, the important purpose of the advance search is to perform the ICSR duplicate check and prevent the entry of replicated cases.

To search for ICSRs

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

    Accessing ICSR list
    Figure 1. Accessing ICSR list

  2. On the ICSR List page that opens, use the search options as follows.

Upon applying the search, the system displays the results satisfying the specified parameters.

Tip

The search results are based on the study access permission granted via ADMIN.

See also
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.

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.

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.

A unique identification number assigned to each lot of items via the IWRS system.

A Chinese national regulatory organization that supervises the safety, registration procedures, and standard management for drugs (including traditional Chinese medicines (TCMs) and ethnomedicine), medical devices, and cosmetics.

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.