MyRBQM® Glossary

1. CRO (Contract Research Organization) — An independent provider hired by a research sponsor to manage clinical trials and other support services on its behalf.
2. CD (Critical Data) — Data that are critical to the reliability of study findings, specifically data supporting primary and key secondary endpoints, as well as data related to subject safety and rights.
3. CP (Critical Processes) — Processes critical to the reliability of study findings and to ensuring subject safety and rights.
4. CSM (Centralized Statistical Monitoring) — A method of monitoring the quality of clinical trials by analyzing data from multiple sites to identify trends, outliers, and inconsistencies.
5. DDE (Direct Data Entry) — A method of data entry where data is entered directly into the electronic system without being written or coded on paper first.
6. DM (Data Management) — The process of collecting, storing, and using data securely, efficiently, and cost-effectively.
7. EDC (Electronic Data Capture) — A computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials.
8. FDA (Food and Drug Administration) — The federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices in the United States.
9. fcAR (Form Correction Attributable Risk) — The contribution of a particular form type to the total number of corrections in the study.
10. KRIs (Key Risk Indicators) — Metrics that typically trigger risk mitigation actions at the site and/or country level.
11. QbD (Quality by Design) — A systematic approach to ensure that clinical trial planning and design focuses on, and is performed, to mitigate errors that would have the greatest impact on subject safety and data quality.
12. QTLs (Quality Tolerance Limits) —Key thresholds of acceptable study risk and deviations.
13. RBM (Risk-based Monitoring) — A method of monitoring clinical trials that involves identifying and focusing on the risks that are most important to the safety of participants and the integrity of trial data.
14. RBQM (Risk-based Quality Management) — A systematic process to identify, prioritize, assess, control, communicate, and review risks associated with clinical trial planning, design, and execution through completion.
15. SDR (Source Data Review) — The review of source documentation to assess quality, data integrity, and compliance.
16. SDV (Source Data Verification) — Process by which data from the case report form (CRF) or other data collection tool is compared to the original source of information to verify that the data are transcribed and captured accurately.