Overview of the Risk Assessment and Categorization Tool (RACT)

Permissions: RACT Assessment Read Only: Users can view assessments and exports (no edits).
RACT Assessment Read Write: Users can create, edit, archive, and finalize assessments and risks.
Risk Management Configuration: Add, edit, delete, and manage all global CTQs, Considerations, Risk Libraries, KRIs, QTLs, Functional Plans, Critical Data, Critical Processes, Alerts.

The Risk Assessment and Categorization Tool (RACT) supports the initial and ongoing assessment and categorization of risks associated with a clinical study. It also records the action plans that the study team uses to manage those risks.

The RACT features:

Assessment of initial study risks and updates through periodic reviews at set intervals or whenever protocol changes happen.
Identification and tracking of critical data and processes by linking identified study risks to relevant critical items.
Review of identified study risks and assessment scores to gain insights through the analysis from past assessments.
Use Risk Libraries with AI help to select a pre-configured risk and quickly generate an if / due to / then statement with one click.
Attach pre-defined critical data / processes, functional plans, KRIs, and QTLs to the RACT Assessment.
Risk tracking and identification uses a locked global-level Risk ID for traceability and assigns a study-level Risk Assessment ID for more detailed identification within assessments.
RACT integrates with the Integrated Data Review Plan (IDRP) to align identified risks with related Review Objectives in Data Central.

Note: Configuration is only required once in Risk Management Configuration. All configurations created (CTQs, QTLs, KRIs, Critical Data / Processes, etc.) are global and accessible to every study.

Access the RACT

Click the 9-dot icon to open the Platform Menu.

Select Risk Management under Risk Management.
The Risk Management page opens. Find the study and click the RACT card.

Choose the Risk Assessment & Categorization Tool under Risk Management.
Pick a study from the list on the right, or click the study icon next to Risk Assessment & Categorization Tool to open the most recently viewed study.

The RACT Landing Page opens for the selected study.

Tip: Links to RBQM and Risk Management are available at the bottom of the left navigation. This allows users to navigate seamlessly between Risk Management, RACT, and RBQM.

RACT Study Landing Page

The RACT Study Landing Page opens for the currently selected study and defaults to the Assessments view. Archived and Risk Summary are accessible through the left navigation.

Assessments

The default view that lists every assessment version for the selected study.

Page Actions

Start Assessment: Creates a new assessment version and opens it in edit mode. If an existing active draft version exists, it is overwritten.
Archive: Click to archive finalized versions. Archived assessment versions cannot be recovered.
Compare: Opens a side-by-side comparison for two selected finalized versions.
Filters: Turns solid when any column filter is active. Click to clear filters.

Assessment Versions Listing

Version: Hyperlink that opens the assessment version. The name displays as Draft until the version is finalized and named.
Status:
- Active: This assessment is in progress and can be edited until it is finalized.
- Finalized: When all risks have been addressed, the assessment can be finalized. No edits can be made to a finalized version, but it remains available for viewing and report export.
Setting: Displays the Assessment Setting used for the assessment version
Description: Text entered during finalization.
Start Date / Start User: The date and the user are recorded at assessment start.
Finalize Date / Finalize User: The date and the user are recorded when the assessment is finalized.
Total Risks: The count of risk cards across all CTQs in the assessment version.

Note: The columns Status, Start Date, Start User, Finalize Date, Finalize User, and Total Risks are automatically populated.

Archived

Lists assessment versions that have been removed from active use. Archiving moves a finalized version out of the Assessments view, captures the Archive Date, User, and Reason, and locks the version against further edits or viewing. Only the summary row remains for audit reference.

Risk Summary

Provides a study-wide catalog of all Risks created across all assessment versions. The consolidated view supports trend analysis, audit preparation, and risk coverage verification without requiring the opening of individual assessments.

Note: Columns in the listings on the Assessments, Archived, and Risk Summary views can be sorted, filtered, resized, or fixed. Filtered columns display a solid filter icon, and the Filters icon on the toolbar turns solid when filters are active. Click the icon to open a submenu that allows users to clear all filters or remove specific ones.

A blue badge displayed in the listing header indicates the number of rows in the current filtered view.

Assessment Version Landing Page

The steps below describe the workflow for conducting an assessment, from opening or starting a version, selecting CTQs and CTQ Considerations, adding Risks, validating completeness, and finalizing the results.

To access the RACT Version Assessment page:

Click Start Assessment to open a new assessment version.
Click the hyperlink in the Version column on the Assessment tab to open that specific assessment version.
When the page opens, Considerations are grouped by CTQs in the left navigation. The right side displays all Risks assigned to the study as individual cards.

Study Assessment Page

Assessment Header

Back Arrow: Returns the user back to the Assessment view with the Assessment Versions listing for the study.
Display Pills: Show the current status, total CTQ Considerations, and total Risks, with counts that update automatically.
Report: Downloads a read-only report, aligned with ICH E6 (R3) guidelines. Export options include Excel and PDF. At least one risk must be added to activate the report icon and enable printing.
View All Risks: Shows a combined list of all Risk cards on the right side of the page, covering all CTQ Considerations.
View Incomplete: Filters Risk cards missing required information that would prevent finalization.
Review and Finalize: Allows ongoing review of the assessment and, when ready, finalizes the version. Use this button to check the assessment's completeness and continue entering information during the review process. Once finalized, the version is locked, the finalization date and user are recorded, and no further edits are allowed.

CTQs, Considerations, & Risks

The left navigation panel shows Considerations grouped under the CTQ heading. A gray badge to the right of each Consideration indicates the number of assigned Risks.
The CTQ Considerations displayed in the left panel are determined by the settings in Risk Management configuration. Setting the status to Inactive for a CTQ or an individual Consideration removes it from the list for all new assessments.
Users can choose which CTQ Considerations to assign Risks to. Even if some Considerations have no Risks added, the version can still be finalized as long as all required fields for the included risks are filled out and the Risks are complete.
When an assessment version opens, the right side displays all Risk cards for the assessment. However, selecting a Consideration in the left panel updates the workspace to display only the Risk cards associated with that Consideration.
A Risk card appears for each Risk added to a Consideration. The card shows the Score, Risk Control Action, Review Plan (IDRP) Indicator, Risk Description, and Risk Evaluation.
Once all the Risks have been completed for the selected CTQ Considerations, the Assessment version can be finalized.

For details on conducting and finalizing an Assessment, see the article, 'Manage Risks and Conduct Assessments in the RACT' in the 'RACT' section.

Export the Risk Management Plan

The exported Risk Management Plan is eTMF-ready, meaning it adheres to industry-standard, Electronic Trial Master File requirements. The report is also compliant with ICH E6 (R3) guidelines, aligning with regulatory expectations for Good Clinical Practice (GCP).

The Risk Management Plan can be exported directly from the Assessment Version page, during assessment review or after the assessment has been finalized. The report can be exported as an Excel or a PDF.

Export Assessment Report

Click the Report icon in the upper right of the of the Assessment Version page..
Select Excel or PDF from the export options.
The report automatically downloads.