DOT certification Exam Study Guide - 2025 Complete Solution
3 regulatory agency sponsors of ICH - ANSEuropean Union, Japan, United States
21 CFR 11 - ANSElectronic Records/Signatures
21 CFR 50 - ANSProtection of Human Subjets/Informed Consent
21 CFR 56 - ANSIRB
21 CFR 312 - ANSIND
21 CFR 812 - ANSIDE
45 CFR - ANSThe Common Rule
45 CFR Part B - ANSPregnant Women and Fetuses
45 CFR Part C - ANSPrisoners
45 CFR Part D - ANSChildren
45 CFR Part E - ANSIRBs
According to GCP guidelines, does the term vulnerable subject also include employees under direct
supervision of clinical investigator? - ANSYes
According to ICH guidelines, how many members should an IRB have? - ANSat least 5
According to ICH guidelines, IRB must retain records for... - ANS3 years
Act - ANSThe Food, Drug and Cosmetic Act, as amended.
Adverse Drug Reaction (ADR) - ANSAll noxious and unintended responses to a medicinal product related
to any dose. (ICH GCP E6 1.1)
Adverse Event (AE) - ANSAny untoward medical occurrence in a patient or clinical investigation subject
administered a pharmaceutical product and which does not necessarily have a causal relationship with
this treatment. (ICH GCP E6 1.2)
Applicable Regulatory Requirements - ANSAny laws and regulations addressing the conduct of clinical
trials of investigational products (ICH GCP E6 1.4)
Are devices intended solely for veterinary use exempt form IDE regulations? - ANSYes
Assent - ANSA child's affirmative agreement to participate in a clinical investigation. Mere failure to object
may not, absent affirmative agreement, be construed as assent. (21 CFR, sec. 50.3)
Audit - ANSA systematic and independent examination of trial related activities and documents to
determine whether the evaluated trial related activities were conducted, and the data were recorded,
analyzed and accurately reported according to the protocol, sponsors SOPs, GCP and the applicable
regulatory requirements. (ICH GCP E6 1.6)
Audit Certificate - ANSA declaration of the confirmation by the auditor that an audit has taken place. (ICH
GCP E6 1.7)
Audit Report - ANSA written evaluation by the sponsor's auditor of the results of the audit. (ICH GCP E6
1.8)
, DOT certification Exam Study Guide - 2025 Complete Solution
Audit Trail - ANSDocumentation that allow reconstruction of the course of events. (ICH GCP E6 1.9)
Belmont Report - ANS1979
Biometrics - ANSA 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)
Blinding/Masking - ANSA procedure in which one or more parties to the trial are kept unaware of the
treatment assignment. (ICH GCP E6 1.10)
Case Report Form (CRF) - ANSA printed, optical, or electronic document designed to record all of the
protocol required information to be reported to the sponsor on each trial subject. (ICH GCP E6 1.11)
Certification - ANSThe official notification by the institution to the supporting department or agency, in
accordance with the requirements of this policy, that a research project or activity involving human
subjects has been reviewed and approved by an IRB in accordance with an approved assurance. (45
CFR, sec. 46.102)
Children - ANSPersons 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)
Circumstances/conditions required for informed consent - ANS- subject has had sufficient opportunity to
consider whether to participate
- the possibility of coercion or undue influence is minimized
Class I Device - ANSLow risk, examples include bandages, exam gloves, Q-tips
Class II Device - ANSMedium risk, examples include powered wheelchairs, infusion pumps, surgical
drapes
Class III Device - ANSHighest risk, examples include heart valves, breast implants, pacemakers
Clinical Investigation - ANSAny experiment that involves a test article and one or more human subjects
and that either is subject to requirements for prior submission to the Food and Drug Administration under
section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and
Drug Administration under these sections of the Act, but the results of which are intended to be submitted
later to, or held for inspection by, the Food and Drug Administration as part of an application for a
research or marketing permit. (21 CFR, sec. 50.3)
Clinical Trial/Study Report - ANSA written description of a trial/study of any therapeutic, prophylactic or
diagnostic agent conducted in human subjects, in which the clinical and statistical description,
presentations, and analysis are fully integrated into a single report. (ICH GCP E6 1.13)
Closed System - ANSAn 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)
Comparator (Product) - ANSAn investigational or marketed product (i.e. active control). or placebo, used
as a reference in a clinical trial. (ICH GCP E6 1.14)
Compliance - ANSAdherence to all the trial related requirements, GCP requirements and the applicable
regulatory requirements. (ICH GCP E6 1.15)
3 regulatory agency sponsors of ICH - ANSEuropean Union, Japan, United States
21 CFR 11 - ANSElectronic Records/Signatures
21 CFR 50 - ANSProtection of Human Subjets/Informed Consent
21 CFR 56 - ANSIRB
21 CFR 312 - ANSIND
21 CFR 812 - ANSIDE
45 CFR - ANSThe Common Rule
45 CFR Part B - ANSPregnant Women and Fetuses
45 CFR Part C - ANSPrisoners
45 CFR Part D - ANSChildren
45 CFR Part E - ANSIRBs
According to GCP guidelines, does the term vulnerable subject also include employees under direct
supervision of clinical investigator? - ANSYes
According to ICH guidelines, how many members should an IRB have? - ANSat least 5
According to ICH guidelines, IRB must retain records for... - ANS3 years
Act - ANSThe Food, Drug and Cosmetic Act, as amended.
Adverse Drug Reaction (ADR) - ANSAll noxious and unintended responses to a medicinal product related
to any dose. (ICH GCP E6 1.1)
Adverse Event (AE) - ANSAny untoward medical occurrence in a patient or clinical investigation subject
administered a pharmaceutical product and which does not necessarily have a causal relationship with
this treatment. (ICH GCP E6 1.2)
Applicable Regulatory Requirements - ANSAny laws and regulations addressing the conduct of clinical
trials of investigational products (ICH GCP E6 1.4)
Are devices intended solely for veterinary use exempt form IDE regulations? - ANSYes
Assent - ANSA child's affirmative agreement to participate in a clinical investigation. Mere failure to object
may not, absent affirmative agreement, be construed as assent. (21 CFR, sec. 50.3)
Audit - ANSA systematic and independent examination of trial related activities and documents to
determine whether the evaluated trial related activities were conducted, and the data were recorded,
analyzed and accurately reported according to the protocol, sponsors SOPs, GCP and the applicable
regulatory requirements. (ICH GCP E6 1.6)
Audit Certificate - ANSA declaration of the confirmation by the auditor that an audit has taken place. (ICH
GCP E6 1.7)
Audit Report - ANSA written evaluation by the sponsor's auditor of the results of the audit. (ICH GCP E6
1.8)
, DOT certification Exam Study Guide - 2025 Complete Solution
Audit Trail - ANSDocumentation that allow reconstruction of the course of events. (ICH GCP E6 1.9)
Belmont Report - ANS1979
Biometrics - ANSA 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)
Blinding/Masking - ANSA procedure in which one or more parties to the trial are kept unaware of the
treatment assignment. (ICH GCP E6 1.10)
Case Report Form (CRF) - ANSA printed, optical, or electronic document designed to record all of the
protocol required information to be reported to the sponsor on each trial subject. (ICH GCP E6 1.11)
Certification - ANSThe official notification by the institution to the supporting department or agency, in
accordance with the requirements of this policy, that a research project or activity involving human
subjects has been reviewed and approved by an IRB in accordance with an approved assurance. (45
CFR, sec. 46.102)
Children - ANSPersons 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)
Circumstances/conditions required for informed consent - ANS- subject has had sufficient opportunity to
consider whether to participate
- the possibility of coercion or undue influence is minimized
Class I Device - ANSLow risk, examples include bandages, exam gloves, Q-tips
Class II Device - ANSMedium risk, examples include powered wheelchairs, infusion pumps, surgical
drapes
Class III Device - ANSHighest risk, examples include heart valves, breast implants, pacemakers
Clinical Investigation - ANSAny experiment that involves a test article and one or more human subjects
and that either is subject to requirements for prior submission to the Food and Drug Administration under
section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and
Drug Administration under these sections of the Act, but the results of which are intended to be submitted
later to, or held for inspection by, the Food and Drug Administration as part of an application for a
research or marketing permit. (21 CFR, sec. 50.3)
Clinical Trial/Study Report - ANSA written description of a trial/study of any therapeutic, prophylactic or
diagnostic agent conducted in human subjects, in which the clinical and statistical description,
presentations, and analysis are fully integrated into a single report. (ICH GCP E6 1.13)
Closed System - ANSAn 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)
Comparator (Product) - ANSAn investigational or marketed product (i.e. active control). or placebo, used
as a reference in a clinical trial. (ICH GCP E6 1.14)
Compliance - ANSAdherence to all the trial related requirements, GCP requirements and the applicable
regulatory requirements. (ICH GCP E6 1.15)
