YY/T 2000-2026Medical device real world data - Terms and definitions (English PDF)

3.1 identifier

One or more attributes in microdata can enable the unique identification of the individual's personal information subject.

[Source. GB/T 37964-2019, 3.6]

3.2 case-control study

Patients who experienced the outcome event were assigned to the case group, and patients who did not experience the outcome event were assigned to the control group. The cases and control groups were compared.

The proportion of the instrument under study is used to investigate the relationship between the instrument under study and the outcome event.

[Source. Guiding Principles for Registration Review of Real-World Research Design and Statistical Analysis for Medical Devices, II (II) 3]

3.3 Case crossover study

This is an observational study design commonly used to investigate the relationship between short-term exposure and acute outcome events. In the evaluation of device safety and effectiveness,

Each case served as its own control at different time points before and after the event, and the use of the studied device was compared between the cases before and after the event.

The relationship between the use of the device and the event is assessed based on the device's condition.

[Source. Guiding Principles for Registration Review of Real-World Research Design and Statistical Analysis for Medical Devices, II (II) 4]

3.4 Traditional clinical investigation

Trials conducted in specialized research institutions and on specific populations.

Note. Various measures are often employed to control variability and ensure data quality, such as detailed inclusion and exclusion criteria, and detailed case report forms (unlike ordinary ones).

Medical records), enhanced monitoring and auditing (to ensure strict adherence to research protocols), and rigorous, accurate data collection are all typically involved. A significant amount of effort is also usually dedicated to this.

To ensure treatment adherence and avoid the use of concomitant treatments that could affect the effectiveness of randomized therapy.

[Source. FDA "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical de-

[vice] (modified)

3.5 representativeness

Does the population included in the data cover the target population of the study?