DOT certification Exam Study Guide - 2023/2024 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
, DOT certification Exam Study Guide - 2023/2024 Complete Solution
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)
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
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
, DOT certification Exam Study Guide - 2023/2024 Complete Solution
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)
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
