Create a validation check

Before you create a validation check, you must create a batch where you want to execute it; see Create a validation check batch.

For details on creating a validation check, see this video:

1. Click the Study Configuration main menu icon from the navigation bar. Then, click the Validation Checks tab.
2. Select the data model where you want to create the validation check from the Data Models panel.
3. Select the validation check batch where you want the new validation check executed.

   Note:

   You must create a batch for the validation check before you crate the validation check. If necessary, see Create a validation check batch to create a batch.
4. Click the Create Validation Check (plus sign) icon from the top of the Validation Checks for Batch table.
5. In the Name field, enter a name. (See Naming restrictions for details.) Then enter a description in the Description field. The name is displayed on the Validation Checks Listings page; the description is not.

   The remaining details affect the discrepancies created by the validation check:

6. Discrepancy Text: Describe the problem with the data and/or the action required. Maximum 255 characters.
7. Select Authorize access to this listing for users without Blind Break rights if you know that only non-blinded columns will be displayed in the listing. This option is available only if at least one source table contains blinded data and if you have special privileges.

   If you do not select this option and one of the source tables is blinded, the system completely blinds the listing. To see any data, a user with Blind Break privileges must break the blind.

8. Discrepancy Initial State: Select a state to be applied to discrepancies created by this validation check: Open or Candidate. Use Candidate to require manual review for setting the discrepancies to Open.
9. (Optional) Select a Category. The validation check applies this category to each discrepancy it creates. Users can filter discrepancies by category.

   Note:

   If you change the category, all new discrepancies created by the check have the new category, but the category of existing discrepancies remains the same.

10. (Optional) Select the Initial Discrepancy Action you want the validation check to immediately perform on new discrepancies, if any.

    • Needs DM Review adds this tag to discrepancies with either initial state. Discrepancies must be reviewed in DMW before being sent to InForm or a lab.

    • Open InForm immediately sends the discrepancy to InForm as an open query. Available only for data in an InForm clinical data model and only if you selected Open as the initial state.

      Note:

      Come back and select the Discrepant Table and Discrepant Column after selecting the tables and columns to be displayed. See Select columns to display in the validation checks listings page.

11. Execution Order: (Available only in ordered validation check batches.) Enter a number to indicate the order in which this validation check should be run, in relation to other validation checks in the same batch. The system runs the lowest numbered check first, then the next lowest, and so on. The numbers do not need to be consecutive, and you may want to use numbers divisible by 10, for example, so that you can add a new validation check at any point.
12. Continue on Error: (Available only in ordered validation check batches.)

    • If set to Yes, the batch continues to execute subsequent validation checks even after one fails.

    • If set to No, execution stops if one of the checks fails.

    Unordered batches always run all validation checks.

13. Allow Auto Close: If selected, rerunning the validation check closes any discrepancy it created if the underlying data item is modified so that it no longer meets the criteria of the validation check.

    If not selected, rerunning the validation check changes the state of such discrepancies to Answered so that they can be manually closed after review.

Next: Complete the validation check:

• Complete a validation check without a custom program
• Complete a validation check using a custom program