Title 21 Definitions Flashcards
Act
Federal food drug and cosmetic act
Agency
Food and Drug Administration
Biometrics
Verifying and measuring an individuals identity based on physical features/ repeatable actions specific to that individual
Closed System
Environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system
Digital Signature
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
Electronic Record
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
Electronic Signature
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
Handwritten Signature
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
Open System
Environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system
Clinical Investigation
Experiment with test article, one or more human subjects, and subject to submission for FDA(either prior or after for inspection)
Investigator
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
Sponsor
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
Emergency Use
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
Human Subject
Individual who is or becomes a participant in research as recipient of test article or control
Institution
Public or private entity or agency (federal, state, or other agencies) synonymous with facility
Institutional Review Board
Board, committee, or othet group formally designated by institution to review, approve initiation of, and conduct periodic review of biomedical research
IRB primary purpose
Assure the protection of the rights and welfare of human subjects
Risk
Probability and magnitude of harm or discomfort anticipated in the reseaech
Minimal Risk
Risk no greater than a subject would ordinarily encounter in life or during the performance of routine physical and psychological examinations or tests
Test Article
Any Drug, biological product, medical device, human food additive, color additive, electronic product for human use subject to regulation
IRB Approval
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
Legally Authorized Representative
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
Family Member
Any individual related by blood ot affinity whose close association with the subject is the equivalent of a family relationship
Assent
A child’s affirmative agreement to participate in a clinical investiagtion
Children
Persons who have not attained legal age for consent to treatments/procedures in clinical investigations
Parent
Child’s biological or adoptive parent
Ward
Child who is placed in the legal custody of state or other agency, institution, entity, consistent with applicable federal, state, or local law
Permission
Agreement of parents or guardians to the participation of their child or ward in a clinical investigation
Guardian
Individual who is authorized under applicable State or local law to consent in behalf of a child to general medical care
