Control group

Results from the device group mean little without a fair comparison. How the control group is formed, ideally by randomization, matters as much as its size.

group of subjects (3.50) that receives the comparator (3.12) Note 1 to entry: A control group may be concurrent or historical, or subjects may serve as their own control.

ISO 14155:2020, clause 3.15

In a clinical outcome study, the group of subjects or specimens who receive the control.

FDA guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013), Section 11, Glossary