21 CFR 50.3 Definitions

Question 1

Act

Answer 1

The Federal Food, Drug, and Cosmetic Act, as amended.

Question 2

Application for research or marketing permit includes

Answer 2

1) A color additive petition, described in part 71
2) A food additive petition, described in parts 171 and 571
3) Data and information about a substance submitted as part of the procedures for establishing that the substance is generally recognized as safe for use that results or may reasonably be expected to result in, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, described in sections 170.30 and 570.30
4) Data and information about a food additive submitted as part of the procedures for food additives permitted to be used on an interim basis pending additional study, described in section 180.1
5) Data and information about a substance submitted as part of the procedures for establishing a tolerance for unavoidable contaminants in food and food packaging materials, described in section 406 of the Act
6) An investigational new drug application, described in part 312 of this chapter
7) A new drug application, described in part 314
8) Data and information about the bioavailability or bioequivalence of drugs for human use submitted as part of the procedures for issuing, amending, or repealing a bioequivalence requirement, described in part 320
9) Data and information about an over-the-counter drug for human use submitted as part of the procedures for classifying these drugs as generally recognized as safe and effective and not misbranded, described in part 330
10) Data and information about a prescription drug for human use submitted as part of the procedures for classifying these drugs as generally recognized as safe and effective and not misbranded, described in this chapter
11) Reserved
12) An application for a biologics license, described in this chapter
13) Data and information about a biological product submitted as part of the procedures for determining that licensed biological products are safe and effective and not misbranded, described in part 601
14) Data and information about an in vitro diagnostic product submitted as part of the procedures for establishing, amending, or repealing a standard for these products, described in part 809
15) An Application for an Investigational Device Exemption, described in part 812
16) Data and information about a medical device submitted as part of the procedures for classifying these devices, described in section 513
17) Data and information about a medical device submitted as part of the procedures for establishing, amending, or repealing a standard for these devices, described in section 514
18) An application for premarket approval of a medical device, described in section 515
19) A product development protocol for a medical device, described in section 515
20) Data and information about an electronic product submitted as part of the procedures for establishing, amending, or repealing a standard for these products, described in section 358 of the Public Health Service Act
21) Data and information about an electronic product submitted as part of the procedures for obtaining a variance from any electronic product performance standard, as described in section 1010.4
22) Data and information about an electronic product submitted as part of the procedures for granting amending, or extending an exemption from a radiation safety performance standard, as described in section 1010.5
23) Data and information about a clinical study of an infant formula when submitted as part of an infant formula notification under section 412c of the Act
24) Data and information submitted in a petition for a nutrient content claim, described in section 101.69 of this chapter
25) Data and information from investigations involving children submitted in a new dietary ingredient notification, described in section 190.6 of this chapter

Question 3

Clinical investigation

Answer 3

Any experiment that involves a test article and one or more human subjects… the results of which are intended to be submitted later to or held for inspection by the FDA as part of an application for a research or marketing permit. Does not include experiments subject to part 58 of this chapter re: nonclinical lab studies

Question 4

Investigator

Answer 4

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.

Question 5

Sponsor

Answer 5

a person who initiates a clinical investigation, but who does not actually conduct the investigation…

Question 6

Sponsor-investigator

Answer 6

an individual who both initiates and actually conducts, alone or with others, a clinical investigation…

Question 7

Human subject

Answer 7

an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.

Question 8

Institution

Answer 8

any public or private entity or agency (including Federal, State, and other agencies). The word facility as used in section 520(g) of the act is deemed to be synonymous with the term institution for purposes of this part.

Question 9

Institutional Review Board (IRB)

Answer 9

any board, committee, or other group formally designated by an institution to review biomedical research involving humans as subjects, to approve the initiation of and conduct periodic review of such research. The term has the same meaning as the phrase institutional review committee as used in section 520(g) of the act.

Question 10

Test article

Answer 10

any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 and 354-360F of the Public Health Service Act (42 U.S.C. 262 and 263b-263n).

Question 11

Minimal risk

Answer 11

the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Question 12

Legally authorized representative

Answer 12

an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s particpation in the procedure(s) involved in the research.

Question 13

Family member

Answer 13

any one of the following legally competent persons: Spouse; parents; children (including adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related by blood or affinity whose close association with the subject is the equivalent of a family relationship.

Question 14

Assent

Answer 14

a child’s affirmative agreement to participate in a clinical investigation. Mere failure to object should not, absent affirmative agreement, be construed as assent.

Question 15

Children

Answer 15

persons who have not attained the legal age for consent to treatments or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted.

Question 16

Parent

Answer 16

a child’s biological or adoptive parent.

Question 17

Ward

Answer 17

a child who is placed in the legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, State, or local law.

Question 18

Permission

Answer 18

the agreement of parent(s) or guardian to the participation of their child or ward in a clinical investigation.

Question 19

Guardian

Answer 19

an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.