Biometrics - ANSWER A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual a
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Biometrics - ANSWER A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3)
Closed System - ANSWER An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3)
Digital Signature - ANSWER An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. (21 CFR, Sec. 11.3)
Electronic Record - ANSWER Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system. (21 CFR, Sec. 11.3)
Electronic Signature - ANSWER A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding equivalent of the handwritten signature. (21 CFR, Sec. 11.3)
Open system - ANSWER An environment in which system access is not controlled by persons who are responsible for the content of the electronic records that are on the system. (21 CFR, Sec. 11.3)
Clinical Investigation - ANSWER - Any experiment that involves a test article and one or more human subjects
- Subject to requirements for prior submission or is not subject to requirements for prior submission to the FDA under the Act
- 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.
(21 CFR, sec. 50.3)
Investigator - ANSWER 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, sec. 50.3)
Sponsor - ANSWER A person who initiates a clinical investigation but who does not actually conduct the investigation
i.e., the test article is administered or dispensed to, or used involving, a subject under the immediate direction of another individual. A person other than the individual (e.g., corporation or agency) that uses one or more of its own employees to conduct a clinical investigation it has initiated it has initiated is considered to be a sponsor (not a sponsor-investigator), and the employees are considered to be investigators. (21 CFR, sec. 50.3)
Sponsor-Investigator - ANSWER An individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject. The term does not include any other person other than an individual, e.g. corporation or agency. (21 CFR, sec. 50.3)
Handwritten Signature - ANSWER The scripted name or legal mark of an individual handwritten by that individual. (21 CFR, Sec. 11.3)
Human Subject - ANSWER 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. (21 CFR, sec. 50.3)
Institution - ANSWER Any public or private entity or agency (including Federal, State or other agencies). The word facility as used in section 520(g) of the Act is deemed to by synonymous with the term institution for purposes of this part.(21 CFR, sec. 50.3)
Institutional Review Board (IRB) - ANSWER 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. (21 CFR, sec. 50.3)
Test Article - ANSWER Any food or 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 Services Act. (21 CFR, sec. 50.3)
Minimal Risk - ANSWER Means that the probability and magnitude of harm or discomfort anticipated in the research are no greater in an of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (21 CFR, sec. 50.3)
Legally Authorized Representative - ANSWER An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedures involved. (21 CFR, sec. 50.3)
Family Member - ANSWER 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 equivalent of a family relationship. (21 CFR, sec. 50.3)
Assent - ANSWER A child's affirmative agreement to participate in a clinical investigation. (21 CFR, sec. 50.3)
Children - ANSWER Persons who have not attained the legal age for consent to treatment or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted. (21 CFR, sec. 50.3)
Parent - ANSWER A child's biological or adoptive parent. (21 CFR, sec. 50.3)
Ward - ANSWER A child who is placed in legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, State or Local law. (21 CFR, sec. 50.3)
Permission - ANSWER The agreement of the parent(s) or guardian to the participation of their child or ward in a clinical investigation. Permission must be obtained in compliance with part 50 subpart B and must include all the elements of the informed consent. (21 CFR, sec. 50.3)
Guardian - ANSWER An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care when general medical care includes research. (21 CFR, sec. 50.3)
Emergency Use - ANSWER The use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval. (21 CFR, sec. 56.102)
IRB Approval - ANSWER The determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal Requirements. (21 CFR, sec. 56.102)
Contract Research Organization - ANSWER A person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the FDA. (21 CFR, sec. 312.3)
IND (also called IDE exemption) - ANSWER - An investigational new drug application.
- Permits a device that otherwise would be required to comply w/ a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device
(21 CFR, sec. 312.3)
Independent Ethics Committee (IEC) - ANSWER A review panel that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation and is adequately constituted to provide assurance of that protection. An IRB is one type of IEC. (21 CFR, sec. 312.3)
Custom Device - ANSWER A device that 1) necessarily deviates from devices generally available 2) is not generally available to Physicians/dentists 3) not generally available in finished form for purchase or dispensing 4) is not offered for commercial distribution through labeling/advertising 5) is intended for use by an individual patient named in the order of the physician or dentist and is made to be in a specific form for that patient. (21 CFR, sec. 812.3)
Implant - ANSWER A device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. (21 CFR, sec. 812.3)
Investigational Device - ANSWER A device, including a transitional device that is the object of investigation. (21 CFR, sec. 812.3)
Monitor - ANSWER Noun - individual designated by a sponsor or contract research organization to oversee the progress of an investigation.
Verb - to oversee an investigation.
(21 CFR, sec. 812.3)
Noninvasive diagnostic device or procedure - ANSWER One that does NOT
1) penetrate the skin or mucous membranes of the body, ocular cavity or the urethra
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. (21 CFR, sec. 812.3)
Significant Risk Device - ANSWER An investigational device that
1) is intended as an implant and presents a potential for serious risk to the health, safety or welfare of the subject
2) will be used in supporting or sustaining human life and presents a potential serious risk to the health, safety or welfare of a subject
3) substantially importance in diagnosing, curing , mitigating or treating disease or otherwise preventing impairment of human health. (21 CFR, sec. 812.3)
Termination - ANSWER A discontinuance, by a sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion. (21 CFR, sec. 812.3)
Translational Device - ANSWER A device that FDA considered to be a new drug or an antibiotic drug before May 28, 1976. (21 CFR, sec. 812.3)
Unanticipated Adverse Event - ANSWER Any serious adverse effect on the health or safety or any life-threatening problem or death caused by, or associated with, a device
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