Permissions: Users must have eIQ Review, Data Central Configure, and Study Configure privileges to configure a study for eIQ Review.

elluminate IQ (eIQ) Review must first be enabled at the URL and study levels, as well as for the user. eIQ resides in Data Central, and therefore, configuration is in Data Central Configuration.

1. Access Data Central Configuration for an eIQ Review enabled study. eIQ Review is listed in the left navigation.
2. Expand eIQ Review.

Configure CSM Model

1. Click CSM in the left navigation.

   

2. Enable CSM: Click the Enable CSM checkbox. When this is checked, the model detecting anomalous lab tests and vital signs tests becomes available.
3. CSM Model Version: No selection required.
4. Data Store for CSM Model: Select the data store from where the data will be accessed. The selected data store requires SDTM mapped data and should have the required domains present. Clinical and Reporting are the most used data stores. The selected data store should be enabled for data review within Data Review configuration.
5. Required Domains for this model: LB, VS, and DM: No selection required. Confirm the selected data store contains these domains.
6. Click Save.

Configure Anomalous AE duration Model

1. Click Anomalous AE duration in the left navigation.

   

2. Enable AE Duration: Click the Enable AE Duration checkbox. When this is checked, the model detecting anomalous AE durations becomes available.
3. AE Duration Model Version: No selection required.
4. Data Store for AE Duration Model: Select the data store from where the data will be accessed. The selected data store requires SDTM mapped data and should have the required domains present. Clinical and Reporting are the most used data stores. The selected data store should be enabled for data review within Data Review configuration.
5. Required Domains for this model: DM and AE: No selection required. Confirm the selected data store contains these domains.
6. Click Save.

Configure Anomalous CM duration Model

1. Click Anomalous CM duration in the left navigation.

   

2. Enable CM Duration: Click the Enable CM Duration checkbox. When this is checked, the model detecting anomalous CM durations becomes available.
3. CM Duration Model Version: No selection required.
4. Data Store for CM Duration Model: Select the data store from where the data will be accessed. The selected data store requires SDTM mapped data and should have the required domains present. Clinical and Reporting are the most used data stores. The selected data store should be enabled for data review within Data Review configuration.
5. Required Domains for this model: DM and CM: No selection required. Confirm the selected data store contains these domains.
6. Click Save.

Configure Anomalous shift in labs/vitals Model

1. Click Anomalous shift in labs/vitals in the left navigation.

   

2. Enable Shifts in Labs and Vitals: Click the Enable Shifts in Labs and Vitals checkbox. When this is checked, the model identifying anomalous shift in labs becomes available.
3. Shifts in Labs and Vitals Model Version: No selection required.
4. Data Store for Shifts in Labs and Vitals Model: Select the data store from where the data will be accessed. The selected data store requires SDTM mapped data. Clinical and Reporting are the most used data stores. The selected data store should be enabled for data review within Data Review configuration.
5. Required Domains for this model: DM, LB, and VS: No selection required. Confirm the selected data store contains these domains.
6. Click Save.

Configure Generalized Data Review Models

1. Click Generalized Data Review in the left navigation.

   

2. Enable Generalized Data Review (GDR): Click the Enable GDR checkbox. When this is checked, all three models (Item Type Model, Incorrect Item Type Model, and Univariate Outlier Detection Model) become available.
3. GDR Model Version: No selection required.
4. Input Data Configuration: Click the Add icon at the top right to add a new row. In the new row, select the data the models will run on.
   1. Data Store: Click the drop-down and select the Data Store the Domain is present in.
   2. Domain: Click the drop-down and select the Domain the Variable is present in.
   3. Variable: Click the drop-down and select the Variable the model will run on.
   4. Group by 1, 2, 3: Click the drop-down and select the Variable(s) to be grouped together in the anomaly detection list.
5. To delete a row, click the checkbox at the left of the row, then click the Delete icon.
6. Click Save.

Configure Domain Classification Model

1. Click Domain Classification in the left navigation.

   

2. Enable DMCL / Enable DMCL - MH / Enable DMCL - AE: Click the Enable DMCL checkbox, then click in the checkboxes for the individual DMCL domain models. When these are checked, the model becomes available for the selected domains, i.e., MH and AE.
3. Model Version: No selection required.
4. SDTM Configuration Data Store: Select the data store from the drop-down containing the SDTM mapped data.
5. Required Domains for this model: DM, MH (if domain model is enabled), and AE (if domain model is enabled): No selection required. Confirm the selected data store contains these domains.
6. Source Data Configuration: Click the Add icon at the top right to add a new row. In the new row, select the data the models will run on.
   1. Data Store: Click the drop-down and select the Data Store the Domain is present in.
   2. Domain: Click the drop-down and select the Domain the Variable is present in.
   3. Variable: Click the drop-down and select the Variable the model will run on.
   4. Type: Click the drop-down and select the type of data.
7. To delete a row, click the checkbox at the left of the row, then click the Delete icon.
8. Click Save.

Configure CM Consistency Model

1. Click CM Consistency in the left navigation.

   

2. Enable CM Consistency: Click the Enable CM Consistency checkbox. When this is checked, the model detecting CM inconsistencies becomes available.
3. CM Consistency Model Version: No selection required.
4. Data Store for CM Consistency Model: Select the data store from where the data will be accessed. The selected data store requires SDTM mapped data and should have the required domains present. Clinical and Reporting are the most used data stores. The selected data store should be enabled for data review within Data Review configuration.
5. Required Domains for this model: CM, DM, and VS: No selection required. Confirm the selected data store contains these domains.
6. Click Save.

Configure CM Indication Model

1. Click CM Indication in the left navigation.

   

2. Enable CM Indication: Click the Enable CM Indication checkbox. When this is checked, the model detecting anomalous pairs of CM and indications becomes available.
3. CM Indication Model Version: No selection required.
4. Data Store for CM Indication Model: Select the data store from where the data will be accessed. The selected data store requires SDTM mapped data and should have the required domains present. Clinical and Reporting are the most used data stores. The selected data store should be enabled for data review within Data Review configuration.
5. Required Domains for this model: CM: No selection required. Confirm the selected data store contains this domain.
6. Click Save.

Configure Irregular Data Patterns Model (Audit Trail Review)

Important: Configuring this model requires additional steps. The model must be enabled first (under eIQ Review), then data must be imported, then the Irregular Data Patterns (under Data Review) datastore must be configured.

Note: Configuration of this model enables Audit Trail Review in eIQ Review.

1. Enable Irregular Data Patterns under eIQ Review

1. Click Irregular Data Patterns in the left navigation.

   

2. Enable Irregular Data Patterns: Click the Enable Irregular Data Patterns checkbox. When this is checked, the model becomes available in the Audit Trail Review Workspace.
3. Irregular Data Patterns Model Version: No selection required.
4. Data Store for Irregular Data Patterns Model: ODM_Mapped is pre-filled.
5. Required Domains for this model: Audit: No selection required.
6. Click Save.

2. Import the Data

Using Importer, import the data. This is the ODM Mapped Datastore which contains the required audit trail data received from the RAVE EDC environment.

3. Configure Irregular Data Patterns (datastore) under Data Review

After data is imported, the Irregular Data Patterns datastore becomes available for configuration.

1. Click Data Review in the left navigation. The list of Data Stores displays below Data Review.

2. Click Irregular Data Patterns.

   

3. Default Identifiers tab
   1. Subject ID: Select Site ID from the drop-down.
   2. Site ID: Select Site ID from the drop-down.
   3. Click the Validate Keys button to check / validate the key configuration. A separate window opens with a listing of the domain(s) and warning message(s) if there are any non-unique key combinations for the defined keys. Warning messages are informational only, no corrective action is enforced. Warning messages may include:
      • Keys do not produce unique results. The following values are duplicated: results are listed.
        • No keys defined.
        • If no validation errors are found for a data store, 'No validation errors found!' displays.
      • Click Close to close the Key Validation warning messages window.
4. Identifier Overrides tab - No updates needed under this tab.

5. Review Settings tab

   

   Tip: Selecting 'Enable Data Review' automatically selects 'Show Domains' if it is not already selected. Deselecting 'Show Domains' automatically deselects 'Enable Data Review' if it is selected.

   1. For each role listed:
      1. Check Show Domains for the domains to display in Data Central.
      2. Check Enable Data Review to enable records to be marked as reviewed. If this is not checked, users can still view the data, but cannot mark records as reviewed.

      3. Click the Domain Settings configure icon to open a separate window.

         

         1. New Domains are automatically Visible: check to automatically include added domains.
         2. New Domains automatically set to Review: check to automatically enable data review for added domains.
         3. Show Domains: Either check 'Select all for Show Domains', or check individually for each Domain.
         4. Enable Data Review: Either check 'Select all for Enable all domains' for data review, or check individually for each domain.
         5. Click Apply (at bottom right).
6. Click Save (at top right).