Groups of people in a performance study:

"Subject" 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 unable to give consent (Art. 60), minors (Art. 61), pregnant or lactating women (Art. 62), and performance studies in emergencies (Art. 64)

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