Create a clinical data model for InForm data

For details on creating a clinical data model for InForm data, see this video:

  1. On the Icon is a house. Home page or Icon shows a clipboard.Study Manager interface, select the study and the Development lifecycle stage.

  2. Click the Study Configuration icon Shows gear with pencil iconfrom the navigation bar. Then click the Clinical Data Models tab.

  3. Click the Icon is a plus sign.Add icon for Clinical Data Models at the top of the left pane.

  4. Enter a name and description. See Naming restrictions for details.

  5. For the model type, select Input.

  6. For Input Type, select InForm.

    Tip:

    Don't create an InForm input clinical data model by copying it. There can be only one input InForm model in a study and its metadata must be imported from InForm. However, you can create a target model by copying an input InForm model and modifying it as necessary.
  7. To allow visualization tools access to the data contained in the clinical data model, select the Business Area checkbox.

    You can change the default schema name, BA_model_name. This is what users of the visualization tool will see. Limitation: Use a maximum of 19 characters for the schema name if you plan to create custom listings on the model. Do not use spaces or special characters other than underscore (_).

    For InForm models, business areas for InForm metadata and operational data models are also created, with "M" and "O" in their names, respectively. For example, STUDY12345_M_QC is the name of the metadata model's business area in the quality control lifecycle.

  8. Data Mart: A data mart file contains all current data in a clinical data model for export to an external system. Select data mart type(s) to make available:

    Only the types that are available in your environment are displayed.

    • Oracle Export
    • Text Export
    • SAS Export
  9. Click OK.

    Note:

    Tables with more than 339 columns may cause problems with data loading, transformations, and display in the Listings pages. See My Oracle Support article 2298558.1 for the latest information.

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