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ICSR list

The ICSR List page of PV contains the ICSR records created in PV, generated as a result of reviewing AE and SAE safety data extracted from EDC, imported from the XML file, or imported from PDF.

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The records on the list are based on the study access permission granted to you via ADMIN.

ICSR list
Figure 1. ICSR list

From the ICSR List page, you can perform the following actions:

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 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.

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