YY/T 1956-2025Clinical investigation of in vitro diagnostic reagents - Terms and definitions (English PDF)

3.1 Safety

When the product is used within its intended scope, the risks are acceptable compared with the benefits.

3.2 Case report form casereportform; CRF

A document designed in accordance with the clinical trial protocol for in vitro diagnostic reagents to record the complete data of each subject obtained during the trial.

Department information and data.

3.3 Adverse event; AE

Adverse medical events occurring during clinical trials of in vitro diagnostic reagents, regardless of whether they are related to the in vitro diagnostic reagents.

NOTE 1 Adverse events may result from, for example, inadequate instructions for use, deployment, installation, operation or any malfunction of the in vitro diagnostic reagent.

Sufficient or inappropriate.

NOTE 2 This definition includes equipment failure or reagent failure that has not resulted in death or serious injury but could result in death or serious injury.

Note 3.This definition is not used to determine whether an event should be reported to a regulatory authority.

Note 4.False-negative or false-positive results are not considered adverse events, but in interventional studies, inappropriate patient decisions based on these false-negative or false-positive results may be

Except as decided by the management.

3.4

Recognized measurement procedures that provide measurement results suitable for evaluating the validity of measurement values obtained by other measurement methods of similar quantities

Assignment of values to measurements, calibration or reference materials.

3.5 Comparator

In vitro diagnostic reagents are in vitro diagnostic reagents that have been marketed in the People’s Republic of China and used as controls in clinical trials.

3.6 protocol deviation

Intentional or unintentional failure to comply with the requirements of the in vitro diagnostic reagent clinical trial protocol.