Title 21 Definitions

Question 1

Act

Answer 1

Federal food drug and cosmetic act

Question 2

Agency

Answer 2

Food and Drug Administration

Question 3

Biometrics

Answer 3

Verifying and measuring an individuals identity based on physical features/ repeatable actions specific to that individual

Question 4

Closed System

Answer 4

Environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system

Question 5

Digital Signature

Answer 5

Electronic Signature based upon any photographic methods of originator authentication computed by using a set of rules and a set of parameters such that identity of signer and integrity of data can be verified

Question 6

Electronic Record

Answer 6

Combination of text graphics, data, audio, pictorial, other information, representation, in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system

Question 7

Electronic Signature

Answer 7

Computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding equivalent for individuals handwritten signature

Question 8

Handwritten Signature

Answer 8

Scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form

Question 9

Open System

Answer 9

Environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system

Question 10

Clinical Investigation

Answer 10

Experiment with test article, one or more human subjects, and subject to submission for FDA(either prior or after for inspection)

Question 11

Investigator

Answer 11

Individual conducting clinical investigation

• usually under their immediate direction test article is administered, dispensed to subject
• when team is involved, they are responsible leader of the team

Question 12

Sponsor

Answer 12

Person who initiates but does not conduct clinical investigation
*a person other than a individual (corporation or agency) that uses employees to conduct clinical investigation

Question 13

Emergency Use

Answer 13

Use of a test article on a human when

• in life threatening situation
• no standard acceptable treatment is available
• no sufficient time to obtain IRB

Question 14

Human Subject

Answer 14

Individual who is or becomes a participant in research as recipient of test article or control

Question 15

Institution

Answer 15

Public or private entity or agency (federal, state, or other agencies) synonymous with facility

Question 16

Institutional Review Board

Answer 16

Board, committee, or othet group formally designated by institution to review, approve initiation of, and conduct periodic review of biomedical research

Question 17

IRB primary purpose

Answer 17

Assure the protection of the rights and welfare of human subjects

Question 18

Risk

Answer 18

Probability and magnitude of harm or discomfort anticipated in the reseaech

Question 19

Minimal Risk

Answer 19

Risk no greater than a subject would ordinarily encounter in life or during the performance of routine physical and psychological examinations or tests

Question 20

Test Article

Answer 20

Any Drug, biological product, medical device, human food additive, color additive, electronic product for human use subject to regulation

Question 21

IRB Approval

Answer 21

Determination of the IRB that the clinical investigation has reviewed and may be conducted at an institution within the constraints by IRB and other institutional and Federal Requirement

Question 22

Legally Authorized Representative

Answer 22

Individual/judicial/or other body authorized under applicable law to consent on behalf of a prospective subject for subjects participation in the procedures involved in research

Question 23

Family Member

Answer 23

Any individual related by blood ot affinity whose close association with the subject is the equivalent of a family relationship

Question 24

Assent

Answer 24

A child’s affirmative agreement to participate in a clinical investiagtion

Question 25

Children

Answer 25

Persons who have not attained legal age for consent to treatments/procedures in clinical investigations

Question 26

Parent

Answer 26

Child’s biological or adoptive parent

Question 27

Ward

Answer 27

Child who is placed in the legal custody of state or other agency, institution, entity, consistent with applicable federal, state, or local law

Question 28

Permission

Answer 28

Agreement of parents or guardians to the participation of their child or ward in a clinical investigation

Question 29

Guardian

Answer 29

Individual who is authorized under applicable State or local law to consent in behalf of a child to general medical care