With our minor release 4.10.0 we introduced several new features, improvements and bugfixes. See the most important updates below:
New Features & Improvements:
- Local Lab Data Handling for site-specific ranges: This feature enables sites to enter results from their local lab into the eCRF without the need for unit conversion or selection. It uses site-specific units and reference ranges to standardise and integrate lab data across sites.
- Per-Lab Parameters & Ranges: You define a central list of lab parameters and assign the correct units and reference ranges to each local lab, so that site differences are handled consistently.
- Subject-Specific Ranges: You can set different ranges for defined subject groups (for example by sex or age band) to ensure accurate interpretation across your population.
- Structured Capture & Alerts: Users enter results in a lab table field per visit; each value can be validated against the pre-filled lab’s ranges, with optional out-of-range alerts.
- Mirrored Table Rows for consistent data linkage: This feature mirrors structured table rows – such as Concomitant Medications or lab data – from scheduled event forms into (S)AE forms so the information is fully integrated into safety documentation and workflows.
- Integrated Safety Data: Selected rows from scheduled event tables are mirrored into (S)AE forms by which critical information of the scheduled events becomes part of the safety record. As it’s fully integrated the mirrored content will follow progress, locking, signature, SDV, and notification rules.
- One Source of Truth: Mirrored data stays linked to the source and updates are automatically reflected in the destination, reducing duplicate entry and the amount of reconciliation.
- Simple Control & Setup: Site users choose which rows to mirror and can navigate between source and destination. Setup users configure mirroring via our Trigger Events.
- Extended Smart Fields for numeric outputs (with conditions): This feature lets you create clear, rules-based calculations in the eCRF/ePRO to reduce manual calculations and prevent avoidable errors.
- Rules & Input: Build numeric outputs using comparison operators (<, ≤, >, ≥, ==, !=), logical connectors (AND, OR), and IF–THEN–ELSE with arithmetic. Smart fields can read input values from single-choice/dropdowns, sliders, and numeric fields.
- Common Use Cases: Implement unit conversions (e.g., weight-based dose calculations, lab value conversions) and calculation/derived scores (e.g., decision-support scores, risk scores) directly in your forms.
- Safe Configuration & Syntax Check: As study configurator you can validate formula syntax and test it with example inputs before rolling it out to the study.
- All updates are also available in the survey module, where applicable.
You can view and download the release notes for the 4.10.0 version update here.
