1. Study Setup Guide
  2. Set up clinical data models
  3. Create a file input clinical data model

Create a file input clinical data model

For details on creating a file input clinical data model, 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. Make sure the Clinical Data Models tab is selected.

  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 model type, select Input.

  6. For Input Type, select:

    • File to load data files from labs.

    • Name_of_System to load data files from a clinical data capture system other than InForm.

  7. For Input Data File Type select either:

    • Text
    • SAS

  8. For Metadata Source select:

    • None to define tables and columns manually.
    • Load from file. The system can create tables from:
      • A .zip file that contains one metadata (.mdd) file per table. See Required syntax for metadata files.
      • SAS Transport (CPort or XPort) files, a SAS dataset, or a .zip file that contains SAS datasets or text metadata (.mdd) files (not both).

        Tables created by uploading SAS datasets are created as nonblinded. If data should be blinded, you must define blinding attributes manually for tables in the input data model.

      Note:

      • You can create a table from a metadata file and load data into it from a SAS file. Metadata files are the only automated way to create tables with blinding attributes set.
      • Tables with a large number of columns may cause problems with data loading, transformations, and display in the Listings pages. The supported maximum ranges from 260 columns if all columns are individually blinded to 370 columns if the table is either not blinded, has only row blinding, or is completely blinded. See My Oracle Support article 2298558.1 for the latest information.
    • Library Data Model to create tables from a standard library model. If the library model is updated, you can update the study model.

      Tip:

      Library models must be checked in to appear in the list. You can only see models you have access to.
    • Study Data Model to copy tables from a model in another study. Select its project (or other grouping), then its study, and then the model.

      The Copy operation includes transformations that write to the model and validation checks that read from the model.

  9. 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 (_).

  10. 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

  11. Click OK.

Next:

Parent topic: Set up clinical data models