RBQM Abbreviations
KRI
What is a Key Risk Indicator?
Kevin Douglass, Jackie Wilkes, Miki Sakata
Who are the people on the DS RBQM team?
The first step in the RBQM process that "ideally" should start during protocol development.
What is the Identification of Critical Data and Critical Processes?
QTLs should be reviewed every week by the Project Team for the life of the study.
False – QTLs should be reviewed at least Monthly once there are enough participants to make the QTL % meaningful (e.g., 30).
QTL
What is a Quality Tolerance Limit?
Identification of Critical Data & Processes, Risk Identification, Risk Evaluation, Risk Control, Risk Communication, Risk Review, and Risk Reporting.
What are the RBQM activities?
The part of the RBQM process that refers to the incorporation of risk mitigation activities into the operational plans (eg. the medical monitoring plan) – and the implementation of those activities during the study.
What is Risk Control?
QTLs are study-level metrics (KRIs) designed for early detection of systemic process issues.
True – Early detection enables minimization of risks to participant safety and the reliability of the study results.
RACT
What is Risk Assessment & Categorization Tool?
RBQM Fundamentals (parts 1-3), RBQM Overview, QTL Overview, Syneos Health RBQM Overview, IQVIA RBM Concepts.
What are examples of RBQM training?
The part of the RBQM process where the sponsor describes the quality management approach implemented in a trial and summarizes important deviations from the predefined quality tolerance limits and remedial actions taken in the clinical study report.
What is Risk Reporting?
Mitigation actions are required only when a QTL exceeds the upper threshold.
False – mitigation actions are recommended when any concerning trend is identified (e.g., large increases or if the QTL % approaches or exceeds the lower (or warning) threshold.