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EHPRC_SIMG_00007 - Specify Legal Requirements for Endpoints

You can use this Customizing activity to define mandatory endpoints for registration by tonnage band. These endpoints must be covered to fulfill the legal requirements. Endpoints are covered if endpoint data records exist that fulfill the legal requirements based on purpose and study type.

The standard system is delivered with example settings in accordance with the IUCLID dossier templates.

Check that the setting for the Expert Dec. checkbox is correct.

• If you do not select the checkbox and have made settings for the environment parameter COVERAGE_RELEVANCE_CALCULATE in the Customizing activity Specify Environment Parameters for Web Processes, the system calculates coverage.

• If you select the checkbox, you override the environment parameter COVERAGE_RELEVANCE_CALCULATE for individual endpoint chapters and an expert must manually indicate coverage.