What is RACT?
The MyRBQM® Portal contains the integrated risk assessment tool RACT, which is based on TransCelerate’s Risk Assessment and Categorization Tool (RACT). RACT is a list of questions that facilitate the identification and the qualitative assessment of clinical trial risks, organized in 13 to 15 risk categories (as per TransCelerate’s RACT).
RACT checks the severity of risk outcomes, the likelihood of occurrence, and how quickly the risk can be detected — closer to a failure mode, effects and criticality analysis (FMECA) method than TransCelerate’s original RACT. This lets RACT show whether a high risk level comes from severity of impact, from a high probability of occurrence, or from a combination of both (I and P), and that breakdown is documented for each risk in КACT.
The complementary detectability score adds one more dimension: how feasible it is to respond to the risk in time.
In the MyRBQM® Portal RACT is spread across two pages: Risk Management Overview and Risks Overview:
- The Risk Management Overview contains the Study Details, the Risk Flower of the study, information about all released versions of the RACT, the Risks Overview of the study, which summarizes all study risks, their events, causes and effects, and their risk scores, and the Questions Overview, which summarizes all risk categories and questions defining risks for the study.
- Detailed information about the risks of a study are given in the Risk Overview module.
