Permissions: Users may not have access to this tool, most users use Validator instead.
Sponsors with a Pinnacle 21 Enterprise license can validate their data built in elluminate against P21 using their company's enterprise license.

Data Quality uses a 3^rd party tool called Pinnacle 21 Community Validator to validate the structures of the data that have been integrated into elluminate.

Pinnacle 21 Community is a collaborative tool for ensuring clinical data compliance with CDISC standards, including SDTM, ADaM, SEND, Define.xml, and others. Pinnacle 21 Community supports assessment of data fitness and data quality using the following features:

• Validator – FDA validation rules and ability to validate against study specific value level metadata
• Define.xml Generator – creates fully compliant Define.xml for SDTM, SEND, and ADaM datasets
• Data Converter – quickly converts data between SAS XPORT, Data set-XML, Excel, and CSV formats
• ClinicalTrials.gov Miner – aggregates clinical outcome measures / endpoints across trials and therapeutic areas

Access Data Quality

To utilize the Data Quality module, open the desired study from the elluminate home screen and then select the Data Quality tab in the study menu.

1. Access the Data Quality module by clicking on Data Quality from the study level.

   

Data Quality is an optional module that can be enabled at the study level during initial study creation or by editing an existing study configuration. If Data Quality does not appear in the module drop-down for a study, the module may not be enabled for that study or the required privileges may be missing. Contact the elluminate Administrator for assistance.

When Data Quality is enabled for a study, a green dot displays next to Data Quality on the study details page.

Create a Validation Job

1. Open the desired study and select the Data Quality tab. By default, the Data Quality module will open to the Validation Jobs screen. Previously configured Validation jobs (if any) will appear as tiles on this screen.

   

2. To create a new Validation Job, click the plus sign in the upper right of the window. A Create Data Quality Validation window appears.
   

3. In the Create Data Quality Validation window, enter the following parameters to define the standard and domains to be utilized in the validation:

   • Name: Enter a name for the validation job.
   • Validate Using: Select the standard against which the data is to be validated.
   • Use Define XML: Select this option to run validation using the Define.xml identified during study setup. This option is available only when Define.xml is enabled for the study.
   • Data Store: Select the Data Store that contains the data to validate. While Staging Areas and Data Marts are both listed, it is likely that Data Marts will be utilized for validations, as Staging Areas typically store data that has not yet been normalized or mapped to an industry standard.
   • Available Domains: Select the domains to validate. Only the domains within the selected data store display.
   • Arrows: Use the single arrows to move the domains in either direction. The double arrows move all the domains from one column to the other, depending on the direction of the arrows. Click a single domain or multiple domains (by holding CTRL key while left clicking) and hit the single right arrow (">") to add that/those domains to the selection. Or, add all domains by clicking the double right arrow (">>").

   Tip: Hold the CTRL key while clicking with to select multiple domains.

   • Selected Domains: Includes the domains selected from the Available Domains column to be included in the validation.
4. Click Save. The validation now appears as a tile or in the list view on the Validation Jobs screen.
   That validation job is now available to run at any time, or use the calendar icon to schedule to run at a specific time.

Edit a Validation Job

To edit a Validation Job, click the pencil icon and then modify the parameters as if creating a new Validation Job (described above).

Delete a Validation Job

To delete a Validation Job, click the trashcan icon and then confirm deletion when prompted.

Run a Validation Job

To execute a Validation Job, click the run (play) icon.

This may take several minutes depending upon the quantity of domains selected. While running, the job tile will indicate a status of "Processing." Upon completion, the job will show a status of “Completed” and indicate the quantity of errors identified. The results of the validation are then accessible in the Validations and Validation Results tabs.

Processing

Schedule a Validation Job

Validation Jobs can be scheduled to run at specific dates/times and at set intervals. To schedule a Validation Job, click the calendar icon on the desired study and input the information requested in the Task Wizard.

Validations: Status and Export

In the Data Quality module, the Validations tab is a listing of all validations that have been run for the selected study. A new entry is created in the list every time Validation Jobs are run (either via scheduling or manually executed) or when a user manually initiates an ad hoc validation via the Validate button (circled below).

The listing includes the following information for each validation:

• Job ID: Sequential number assigned to each validation.

  Note: This ID does not correspond to the Validation Jobs.

• Status: Indication of the status of the validation action.
• Data Store: The data store containing the data that have been validated. In most cases, this will be a data mart (versus a staging area), as data marts are intended to contain standardized/mapped data.
• Standard: The industry standard against which the data have been validated.
• Define-XML: Whether define-xml was included in the validation.
• Controlled Terminology: The version of controlled terminology used in the validation.
• MedDra Version: The version of the MedDRA dictionary used in the validation.
• Created By: User that created the validation job or manually executed the ad hoc validation.
• Created: Date and time that the validation report was created.

Available Listing Actions

1. Expand the details of each validation by clicking the arrow. This will present the domains validated, as well as the status and result by domain.
2. Export to Excel by clicking the Excel document icon.
3. Delete the results of an executed validation job by click the trashcan icon.

View Validation Results

After a Data Quality validation has completed, the output can be viewed in the Validation Results tab. These results are split into three sub-tabs: 

• Summary - Provides a breakdown of the type of rules that have issues and how many have been reported. For example, there may be 28 errors for rule SD0058. On the Summary tab, instead of seeing each of the 28 errors, they are grouped together as a summary. They are summarized by domain.
• Results - Contains all the rules that were summarized in the summary tab. For example, for the 28 errors for rule SD0058, all 28 would be listed in the Results tab. Click on the Rule ID link to view the rule.
• Rules - Contains a list of Rule IDs and their descriptions. Click anywhere in the row to open a window displaying the validation rule. See the list below for examples.

By default, the Validation Results of the most recent validation job are displayed opened to the Summary tab.

Error Color Coding

Results are color coded by severity to support error review. 

• Information (White): Review to determine whether changes are required.
• Warning (Yellow): Review to determine whether changes are required.
• Error (Pink): Indicates issues that may require review and correction.

Tip: Deselect any of the color codes in the top right to filter the type or severity of the findings displayed in the table.

View Previous Validation Jobs

Select it from the drop-down list at the upper left corner of the window.

1. In the left-side menu, click the checkbox next to the domain for which validation results are reviewed. More than one domain can be selected at a time.
2. Validation results display on the right side of the window. When multiple domains are selected, results display sequentially as the list is scrolled, beginning with the first selected domain.

Rule Description Examples

• “Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists.”
• “Domain table should have at least one record.”
• “Value of Dates/Time variables (*DTC) must conform to the ISO 8601 international standard.”
• “Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset.”