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Medical review

In PV, the Medical Review feature is designed to provide users with convenient access to ICSR data that is relevant to the medical review process in one place. This feature should be used in accordance with the company's specific SOP or WI.

The Medical Review feature includes three tabs as explained in the following table.

Tab

Details

Medical Review

Comprises the Case Narrative, Case Assessment, and Event Assessment blocks.

Temporal View

Comprises a summary and event assessment in a timeline format. You can choose which data to include in the event assessment section according to your needs and preferences.

Contact Log/Action Items/Documents

Comprises the communication history for an ICSR and provides options to add comments or request actions from other users, as well as easily access the attached files from all ICSR versions.

Tip

From Medical Review, you can also forward or return the ICSR workflow route. You can learn more about the ICSR workflow and routing functionality in the ICSR workflow section.

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.

A procedure specific to your operation that describes the activities necessary to complete tasks following industry regulations, provincial laws, or even individual standards for running the business.

Instructions that ensure that each step is performed accurately, with the right materials and tools, and following the proper procedures, all while prioritizing safety and compliance with industry standards.