Use Analytics in the RACT

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Use RACT Analytics to review Risk trends, metrics, mitigation activities, and Integrated Quality Risk Management (IQRM) data.

The Analytics section includes:

  • Overview: Displays Risk analytics across finalized assessment versions.
  • IQRM: Displays analytics for Risks and Review Objectives associated with the latest finalized assessment.

View Overview Analytics

The Overview page provides summary metrics, Risk trends, and distributions across finalized assessment versions.

Tip: Click the Maximize icon in the upper-right corner of a visualization or listing to expand it. Click the Restore icon to return it to its original size.

Overview page showing Risk summary metrics, Risk distributions, mitigation analytics, and Risk Score trends
  1. Under Analytics, click Overview.
  2. Use the filters at the top of the page to refine the displayed data. All options are selected by default.
    Overview page showing the All Assessments multi-select filter with all assessment versions selected
    • All Assessments: Select or clear assessment versions.
    • All CTQs: Select or clear CTQs.
    • All Risk Control Actions: Select or clear Risk Control Actions.
  3. Click Apply to update the analytics based on the selected filters.

Review Summary Metrics

The summary cards provide high-level information about Risks and related Risk management activities:

  • Risks: Displays the total number of Risks and the number assigned to each Risk Control Action. The card also identifies Risks added after the initial assessment.
  • Functional Plans: Displays the total number of Functional Plans associated with Risks.
  • Metrics: Displays the total number of monitoring metrics and the number of QTLs and KRIs. Click the QTL link to open QTL Overview in the RBQM Trial Level Risks dashboard. Click the KRI link to open the KRIs dashboard in RBQM.
  • Mitigations: Displays the total number of mitigation actions and the number of Pre-Study and During Study mitigation actions.

Note: To return to RACT from RBQM, click the RACT link.

Review Risk Analytics

Use the charts to review Risk distributions, scores, metrics, and mitigation activities.

  • Risk Distribution: Displays the number of Risks by assessment version and CTQ.
  • Risk Score (RPN) Over Time: Displays changes in Risk scores across assessment versions. Select Total (default), By CTQ, or By Risk to change the view.
  • KRI Distribution: Displays KRI distribution by CTQ.
  • Mitigation by Risk: Displays Pre-Study and During Study mitigation actions by Risk.
  • Risk Distribution by Functional Plan: Displays Risk distribution across Functional Plans.

Review the Risk Summary

The Risk Summary listing provides detailed information about Risks included in the Overview analytics.

Risk Summary listing showing Risk details and Export, Maximize, and Filter icons

Use the available options to manage the listing:

  • Click the Export icon and select Excel or CSV to export the Risk Summary.
  • Sort or filter columns as needed.
  • Use the Fix options to keep selected columns visible when scrolling horizontally.

View IQRM Analytics

The IQRM page provides analytics for Risks and Review Objectives associated with the latest finalized assessment identified at the top of the page.

Tip: Click the Maximize icon in the upper-right corner of a visualization or listing to expand it. Click the Restore icon to return it to its original size.

IQRM page showing summary metrics, Review Objective Distribution, and the Integrated Quality Risk Management Plan
  1. Under Analytics, click IQRM.
  2. Review the latest finalized assessment identified at the top of the page.
  3. Use the filters to refine the displayed data. All options are selected by default.
    • All CTQs: Select or clear CTQs.
    • All Risk Control Actions: Select or clear Risk Control Actions.
  4. Click Apply to update the analytics based on the selected filters.

Review IQRM Summary Metrics

The summary cards provide information about Risk and Review Objective linkage:

  • Risks linked to Review Objectives: Displays the percentage of Risks linked to Review Objectives and the total number of Risks. Click a segment in the chart to filter the IQRMP listing by the selected linkage status.
  • Risks by Data Reviewer Role: Displays the number of Risks associated with each Data Reviewer Role.
  • Review Objectives linked to Risks: Displays the percentage of Review Objectives linked to Risks and the total number of Review Objectives. Click a segment in the chart to filter the IQRMP listing by the selected linkage status.

View Review Objective Distribution

The Review Objective Distribution chart displays the distribution of Review Objectives associated with Risks.

Select an available view to change how the chart groups the data:

  • By Review Role: Groups Review Objectives by Data Reviewer Role.
  • By CTQ: Groups Review Objectives by CTQ.
  • By Risk: Groups Review Objectives by Risk.

The chart identifies Review Objectives by High Priority, Medium Priority, and Low Priority.

Review the Integrated Quality Risk Management Plan

The Integrated Quality Risk Management Plan (IQRMP) listing provides detailed Risk and Review Objective information for the latest finalized assessment.

Use the available options to manage the listing:

  • Click the Export icon and select Export as Excel or Export as PDF to export the IQRMP.
  • Sort or filter columns as needed.
  • Use the Fix options to keep selected columns visible when scrolling horizontally.

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