Groups of people in a performance study:

"Study participants": means an individual participating in a performance study whose sample(s) is/are subjected to an in vitro study using a performance study device and/or a control device (41)

"Investigator": means the person responsible for conducting a performance study at an institution where the performance study is conducted (48)

"Sponsor": means any person, company, institution, or organization that assumes responsibility for initiating, managing, and establishing funding for the performance study (57)

"Vulnerable populations and subjects": subjects not capable of giving consent (Art. 60), minors (Art. 61), pregnant or lactating women (Art. 62), and performance studies in emergencies (Art. 64)