Review Planner

DQS Review Planner is a centralized framework for creating risk-based review plans for your master study that facilitate your adoption of risk-based data management. In the Review Planner, you can define Targets for monitoring, and configure Reviews to plan and implement mitigation. By establishing direct operational traceability from high-level trial endpoints down to individual checks, listings, and metrics, the Review Planner ensures data review frequency aligns precisely with variable criticality giving teams early visibility into patient safety and data integrity risks before endpoints are compromised.

The DQS Review Planner provides a “golden thread” of traceability, allowing you to explicitly link each strategically important clinical endpoint to its underlying critical data, which you can tie directly to the edit checks and manual review tasks that evaluate them.

Accessing the Review Planner

You can navigate to the Review Planner page from the Navigation Drawer after you select your Study, or the Study menu on the Studies page.

Review Planner from the Navigation Drawer Review Planner from the Study menu

From the Review Planner you can create and view Targets and Reviews for your study.

Review Planner Header

Upon opening the Targets or Reviews tab in the Review Planner area, all the targets and reviews are collapsed. You can click Expand All to display all the associated information for all the targets or reviews on the page, or you can click each one individually to expand it.

Expand All Button

Managing Targets

Targets are endpoints that track critical goals for your trial. You can select the following Target Types for the Target:

  • Endpoint
  • Safety Signal
  • Data Quality
  • Compliance

The Targets tab displays a list of the Targets configured for your study, including any description and their Type, Level (for Endpoint targets), Purpose (for Endpoint targets), and any associated Critical Data.

Targets Tab with Columns

Creating Targets

To create a Target:

  1. Navigate to the Targets tab in the Review Planner area.

  2. On the upper right of the page, click Add Target. The New Target step-based builder opens. Add Target Button

  3. In the Definition step of the New Target builder, select a Target Type. New Target Builder

  4. Enter a Target Name.

  5. Optional: If you selected the Endpoint Target Type, select a Level and Purpose. Select Level and Purpose

  6. Optional: Enter a Risk Description.
  7. In the steps side-bar on the left, click Select Variables to proceed to the next step.

  8. In the Select Variables step, click and drag Available Variables to move them to the Selected Variables list. You can also Search variables. Select Variables Step

  9. In the steps side-bar on the left, click Attach Metrics to proceed to the next step.

  10. Search and click metrics to add Available Metrics to the Selected Metrics list. Attach Metrics Step

  11. Click Save.

Editing Targets

To edit a Target:

  1. Navigate to the Targets tab in the Review Planner area.

  2. From the Menu (), click Edit. The step-based Target builder opens. Edit Action

  3. Make your changes.
  4. Click Save.

Deleting Targets

To delete a Target:

  1. Navigate to the Targets tab in the Review Planner area.
  2. From the Menu (), click Delete. The Target is deleted.

Managing Reviews

The Reviews tab displays the Review Objectives configured for your study, including any description, the associated Target, and any associated Critical Data points.

Review Tab with Columns

In the Reviews tab, you can define operational review objectives complete with mitigations and review frequencies. Assigned role information, which is inherited from the Listing Access permissions for any review listings added to Review Plans as mitigations, are displayed in the Assigned Role column as part of the Review information. For Checks, System is displayed.

Review Example

Creating Reviews

To create a Review:

  1. Click Add Review. Add Review Button

  2. In the New Review step-based builder, enter an Objective Name. New Review Builder

  3. Optional: Enter an Objective Description.
  4. Optional: Select a Target to associate with this Review.

  5. Optional: In the steps side-bar on the left, click Select Mitigations to proceed to the next step. New Review Select Mitigations

  6. Optional: In the Select Mitigations step, click and drag mitigations from the Select Mitigations list to the Selected Mitigations list.
  7. Optional: In the steps side-bar on the left, click Review Logic to proceed to the next step.

  8. Assign a Frequency to any selected review listings. You can also review the Type, Name, Action, Listing Objective, Frequency, Assigned Role, and Status of the selected mitigation. Assign Frequency for Review Listings

  9. Click Save.

Editing Reviews

To edit a Review:

  1. Navigate to the Reviews tab in the Review Planner area.

  2. From the Menu (), click Edit. The step-based Review builder opens. Review Edit Action

  3. Make your changes.
  4. Click Save.

Deleting Reviews

To delete a Review:

  1. Navigate to the Reviews tab in the Review Planner area.
  2. From the Menu (), click Delete. The Review is deleted.

Downloading Review Plans

You can download the Review Plan as a CSV file. DQS names the file “Review Plan datetime.csv”.

To download your review plan:

  1. Navigate to the Review Planner area for your study.
  2. From the Review Planner () menu, select Download Review Plan. Download Review Plan Action

Approving and Deploying Review Plans

Review Plans follow a formal approval and deployment workflow. The review plan must be approved from any of the test environments for the study before a user with deployment permissions can deploy it to production. Review plans are read-only in production environments. Deployment to production automatically sets the review frequencies for any review listings configured as mitigations that are also in production.

Any further updates must be completed in the master study environment, and redeployed. Learn more about approving and deploying review plans.