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ICSR workflow

A workflow is a multi-step route of different statuses that a user may go through while handling ICSR cases. Each workflow is configured individually for every client by EDETEK administrators depending on how many people the company requires to handle ICSR and their internal management processes. When adding steps to a single workflow, the following levels are considered:

  • The effort and resources needed to complete each step are estimated beforehand.

  • The benefit from automation in terms of quality, compliance, and efficiency is estimated.

  • The possibility of failure and validation errors that may occur as a result of automation processes is estimated.

Important

Currently in PV, the default ICSR workflow has ten statuses, such as Draft, Data Entry, Quality Review, Translation, Medical Review, Unblinding, Final Review, Case Submission, Case Archived, and Invalid. The workflow of the ICSR review and approval process can be customarily configured by the EDETEK administrator according to the sponsor's requirements.

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.

sponsor'sThe field can be optional or mandatory depending on the status configuration to which you are forwarding the route.