Create categories for flags, discrepancies, and validation checks

Categories are used for two purposes:

• Labeling Discrepancies Users can filter discrepancies by category.

  Create categories to characterize discrepancies (for example, Protocol Violation, Validation Check Not Working, Range or Date Alignment). Categories can also indicate who should review a discrepancy next (for example, Medical Review, DM Review) as an alternative to creating custom actions using APIs with these labels as tags.

  • Users can assign a category directly to a discrepancy.

  • Users can assign a category to a validation check. The validation check then assigns the category to all discrepancies it creates.

• Flagging Records Categories determine which flags are available to assign to which records. You assign categories to clinical data model types. When you create a flag, you assign a category to it. The flag is then available for users to assign to records in model types assigned to the same category.

  Users can assign flags to records and then filter records by flag.

  Tip:

  To simplify flag creation, include the clinical data model type (Input (InForm), Input (File), and Target) in the name of flag categories.

  A discrepancy, validation check, or flag can have only one category assigned at a time. Some categories are created and used by the system and cannot be modified. They have IDs under 100.

To create a category:

1. Click Navigation from the navigation bar and then click Administration.
2. Click the Categories tab.
3. Click the Add icon.
4. Enter values in the following fields:

   • Category Name: This label is displayed in the Discrepancies, Listings, Validation Check, and Filter user interfaces.

   • Description: (Optional) The description is not displayed anywhere but here.

   • For Discrepancies?: If selected, users can assign the category to discrepancies.

   • For Validation Checks?: If selected, users can assign the category to validation checks. The validation checks then assign the category to the discrepancies they create.

   • For Flags?: If selected, users can assign flags of this category to records in the type(s) of clinical data model you specify. Additional fields appear and you select one or more data model types:

     • Input (File) for input models that receive their data from data files, usually from labs.

     • Input (InForm) for input models that receive their data from InForm.

     • Input (EDC System) for input models that receive their data from an integrated electronic data capture system other than InForm.

     • Target for models whose data is populated by a transformation from other model(s).

5. Click OK. The system assigns an ID greater than 100 to the category.