Investigator

Investigators answer for how the study is run at their site, including consent and records. In US texts the word can also mean an FDA investigator who performs inspections, so context matters.

‘investigator’ means an individual responsible for the conduct of a clinical investigation at a clinical investigation site;

EU MDR, Article 2(54)

‘investigator’ means an individual responsible for the conduct of a performance study at a performance study site;

IVDR, Article 2(48)

Investigator means an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject) or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.

21 CFR, 56.102

Investigator means an individual who collects data or information in support of a postmarket surveillance plan.

21 CFR, 822.3

Investigator means an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.

21 CFR, 50.3

Investigator means an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team. (j) Monitor, when used as a noun, means an individual designated by a sponsor or contract research organization to oversee the progress of an investigation. The monitor may be an employee of a sponsor or a consultant to the sponsor, or an employee of or consultant to a contract research organization. Monitor, when used as a verb, means to oversee an investigation. (k) Noninvasive, when applied to a diagnostic device or procedure, means one that does not by design or intention: (1) Penetrate or pierce the skin or mucous membranes of the body, the ocular cavity, or the urethra, or (2) enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the pharynx, the anal canal beyond the rectum, or the vagina beyond the cervical os. For purposes of this part, blood sampling that involves simple venipuncture is considered noninvasive, and the use of surplus samples of body fluids or tissues that are left over from samples taken for noninvestigational purposes is also considered noninvasive.

21 CFR, 812.3

individual member of the investigation site (3.28) team designated and supervised by the principal investigator (3.39) at an investigation site to perform clinical investigation-related procedures or to make important clinical investigation-related and medical treatment decisions Note 1 to entry: An individual member of the investigation site team can also be called “sub-investigator” or “co-investigator.”

ISO 14155:2020, clause 3.30

The EU definitions tie the investigator to a single study site. The US definitions in 21 CFR 50, 56 and 812 describe the person under whose direction the test article is used, or the leader of a team. 21 CFR 822 uses the word for whoever collects data for a postmarket surveillance plan.