Risk Based Monitoring / Risk Based Quality Management
Risk Based Monitoring (RBM) is now Risk Based Quality Management (RBQM). What does this mean for you? Great things, actually. Oversight Scorecard is not going away, and a RACT tool (new in LSAC) allows risk managers to categorize study/site/therapeutic area-specific risks and reassess the probability and severity of those risks during study conduct by drilling down to specific analytics and dashboards. The combination of RACT and Oversight Scorecard allows users to transition from planning risk assessments to monitoring risks (actively and with automations).
We received a lot of feedback that our risk-monitoring solution was not complete without a way to assess and categorize risk. The new RACT in RBQM facilitates risk planning, assessment, and mitigation in a collaborative manner. Users can leverage a Transcelerate RACT template out-of-the-box (with 13 risk categories and 64 sub-categories), or create custom templates within the RACT console.
Building a risk assessment plan for a particular study can be done by multiple users, and for sponsors and CROs with studies already in LSAC, you’ll be pleased to know that RACTs can be added to existing studies as well.
Clinical Insights: Data Review Tracking
Data Review Tracking (also called Dynamic Data Review or Dynamic Line Listings) allows safety and data teams to track changes to patient concomitant medication, medical history, and adverse events throughout a trial. Updates to the data review tracking analytic allow medical monitoring and safety teams to download and re-upload .csv documents (excel spreadsheets) with their review notes.
Operations Insights: Quality Measures, Data Metrics, Safety, Site Activation, and Enrollment Dashboards
Quality Measures Dashboard – Provides an overview of protocol deviations and related issues across the study. Charts showcase include protocol deviations by category, protocol deviations over time, and issue resolution times by country.
Data Metrics Dashboard – Aggregates information on data collection progress throughout the study. Dashboard charts include data point completion, duration between data point collection and entry, source data verification status, and primary endpoints’ availability for analysis. The incorporation of country, visit, and monthly views consolidates what would normally be several different analytics into a single dashboard.
Safety Dashboard – Summarizes adverse event and serious adverse event to enable an operations audience to start viewing AE data at the entire study level, and then conduct quick drill-downs into problematic countries or sites. The summary cards in this dashboard detail how the study as a whole is performing with respect to some predetermined AE and SAE thresholds, and the charts display cumulative adverse event counts and adverse events by body system. A visual adverse event by country chart is provided at the bottom of the dashboard, along with links to the underlying aggregated AE data.
Site Activation Dashboard – Check out an interface update to a popular dashboard. You can now hover over a particular country, and drill down directly into the listing data for that country, or go to that country’s site activation performance dashboard.
Study Enrollment Dashboard – A concise enrollment funnel is visible alongside contextual summary cards. Users can now pull up patient screen details and subject dispositions in popup windows within the dashboard.
DaLIA: A Facelift & Enhancements to Smart Search
Our Deep Learning Intelligent Assistant (DaLIA) is looking better than ever.
- You can now see autocomplete suggestions while typing a query into the ask DaLIA search bar.
- After typing in a question, DaLIA will propose related questions
- After typing in a question, DaLIA will recommend related dashboards and analytics (ie. if you ask, “what is the last milestone that alpha 33 achieved” DaLIA might recommend the milestone achievement and study summary dashboards)
- You can download DaLIA’s response as a CSV. For example, if you were to ask, “show me a list of sites for study alpha 33 with more than 50% enrollment” you would be able to download a filtered list of sites within that study.
- If DaLIA correctly answered your question, please give her a thumbs up. If she missed the mark, leave a thumbs down and a comment explaining what went wrong. This feedback helps us improve her performance and prioritize her improvements.
Updated Intents: DaLIA is more performant, and continues to improve with each release.
- You can now refer to studies by name, instead of study ID (ie. you can refer to “Alpha 33” instead of “SA33-10D”)
- You can now ask questions about subject dispositions (ie. “how many patients have failed screens in alpha 33?” or “how many patients were randomized in Beta 21 in Germany?”)
- DaLIA is able to answer more complicated questions relating to queries within a study. For example, if you ask, “number of open queries for study alpha 33”
A list of recommended questions can be found here.