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Book Contents

Production environment workflow

When study design and development are complete, use the CIS integrated production environment to:

The following steps illustrate a typical integrated production environment workflow:

  1. Deploy the package to an InForm study database.
  2. Create a synchronization connection between the InForm study database and the Clintrial clinical database, and transfer the protocol component definitions to the Clintrial database through the synchronization process.
  3. Enter clinical data through the InForm software (storing EDC data in the InForm database) and through the Clintrial Enter module (storing the paper-based data in the Clintrial database).
  4. Through a synchronization connection, and using data mapping definitions, transfer the study metadata and the EDC clinical data from the InForm study database to the Clintrial database.
  5. Validate entered data by running Clintrial or InForm rules:
    • Resolve EDC data queries in the InForm software, whether they originate from rules within the InForm database or the Clintrial database.
    • Resolve paper-based data discrepancies by using the Clintrial data validation modules.
  6. Archive and manage study data in the Clintrial clinical data management system.
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