What's included

What goes into study set up

  • Case book and study configuration built against the protocol's investigational product, indications, and study design
  • Reference safety information (investigator's brochure or label) loaded for expectedness assessment at intake
  • MedDRA and WHO Drug coding dictionaries version-locked for the study before data starts flowing
  • User roles, access levels, and workflow routing configured to match the study team and delegation log
  • Database configuration validated end-to-end with test cases before first patient in
  • Configuration documented and version-controlled, ready to support the Safety Management Plan

Built to the protocol, not a default template

Case definitions, forms, and coding references are configured for this study's specific safety profile and reporting obligations.

Validated before it goes live

Test cases confirm the configuration behaves as intended before the database opens for real cases, feeding directly into the SAE Reporting Workflow Setup.

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