SoCRA Certification Exam
21 CFR 11 - ANS-Electronic Records/Signatures
21 CFR 312 - ANS-IND
21 CFR 50 - ANS-Protection of Human Subjets/Informed Consent
21 CFR 56 - ANS-IRB
21 CFR 812 - ANS-IDE
three regulatory corporation sponsors of ICH - ANS-European Union, Japan, United States
forty five CFR - ANS-The Common Rule
forty five CFR Part B - ANS-Pregnant Women and Fetuses
45 CFR Part C - ANS-Prisoners
45 CFR Part D - ANS-Children
forty five CFR Part E - ANS-IRBs
According to GCP tips, does the term inclined difficulty also include employees under direct
supervision of medical investigator? - ANS-Yes
According to ICH guidelines, how many individuals should an IRB have? - ANS-as a minimum
five
According to ICH recommendations, IRB ought to retain facts for... - ANS-3 years
Act - ANS-The Food, Drug and Cosmetic Act, as amended.
Adverse Drug Reaction (ADR) - ANS-All noxious and unintentional responses to a medicinal
product associated with any dose. (ICH GCP E6 1.1)
Adverse Event (AE) - ANS-Any untoward medical prevalence in a affected person or scientific
research difficulty administered a pharmaceutical product and which does no longer necessarily
have a causal relationship with this remedy. (ICH GCP E6 1.2)
, Applicable Regulatory Requirements - ANS-Any legal guidelines and regulations addressing the
conduct of scientific trials of investigational products (ICH GCP E6 1.4)
Are devices intended solely for veterinary use exempt shape IDE guidelines? - ANS-Yes
Assent - ANS-A toddler's affirmative settlement to take part in a medical research. Mere failure
to object might not, absent affirmative agreement, be construed as assent. (21 CFR, sec. 50.3)
Audit - ANS-A systematic and impartial examination of trial related activities and files to
determine whether the evaluated trial related activities have been performed, and the records
were recorded, analyzed and accurately reported consistent with the protocol, sponsors SOPs,
GCP and the relevant regulatory necessities. (ICH GCP E6 1.6)
Audit Certificate - ANS-A statement of the affirmation by using the auditor that an audit has
taken location. (ICH GCP E6 1.7)
Audit Report - ANS-A written evaluation by using the sponsor's auditor of the results of the
audit. (ICH GCP E6 1.Eight)
Audit Trail - ANS-Documentation that permit reconstruction of the path of activities. (ICH GCP
E6 1.Nine)
Belmont Report - ANS-1979
Biometrics - ANS-A approach of verifying an individual's identity based totally on dimension of
the person's physical functions or repeatable moves wherein those capabilities and or
movements are both unique to that man or woman and measurable. (21 CFR, Sec. Eleven.3)
Blinding/Masking - ANS-A method wherein one or more parties to the trial are stored blind to the
treatment mission. (ICH GCP E6 1.10)
Case Report Form (CRF) - ANS-A printed, optical, or digital report designed to report all the
protocol required information to be said to the sponsor on each trial situation. (ICH GCP E6
1.Eleven)
Certification - ANS-The reputable notification by means of the group to the helping department
or agency, according with the necessities of this coverage, that a studies challenge or pastime
related to human topics has been reviewed and accepted by an IRB in accordance with an
accepted warranty. (forty five CFR, sec. 46.102)
Children - ANS-Persons who've now not attained the legal age for consent to treatment or
processes concerned in clinical investigations, beneath the applicable regulation of the
jurisdiction in which the scientific investigation might be conducted. (21 CFR, sec. 50.3)
21 CFR 11 - ANS-Electronic Records/Signatures
21 CFR 312 - ANS-IND
21 CFR 50 - ANS-Protection of Human Subjets/Informed Consent
21 CFR 56 - ANS-IRB
21 CFR 812 - ANS-IDE
three regulatory corporation sponsors of ICH - ANS-European Union, Japan, United States
forty five CFR - ANS-The Common Rule
forty five CFR Part B - ANS-Pregnant Women and Fetuses
45 CFR Part C - ANS-Prisoners
45 CFR Part D - ANS-Children
forty five CFR Part E - ANS-IRBs
According to GCP tips, does the term inclined difficulty also include employees under direct
supervision of medical investigator? - ANS-Yes
According to ICH guidelines, how many individuals should an IRB have? - ANS-as a minimum
five
According to ICH recommendations, IRB ought to retain facts for... - ANS-3 years
Act - ANS-The Food, Drug and Cosmetic Act, as amended.
Adverse Drug Reaction (ADR) - ANS-All noxious and unintentional responses to a medicinal
product associated with any dose. (ICH GCP E6 1.1)
Adverse Event (AE) - ANS-Any untoward medical prevalence in a affected person or scientific
research difficulty administered a pharmaceutical product and which does no longer necessarily
have a causal relationship with this remedy. (ICH GCP E6 1.2)
, Applicable Regulatory Requirements - ANS-Any legal guidelines and regulations addressing the
conduct of scientific trials of investigational products (ICH GCP E6 1.4)
Are devices intended solely for veterinary use exempt shape IDE guidelines? - ANS-Yes
Assent - ANS-A toddler's affirmative settlement to take part in a medical research. Mere failure
to object might not, absent affirmative agreement, be construed as assent. (21 CFR, sec. 50.3)
Audit - ANS-A systematic and impartial examination of trial related activities and files to
determine whether the evaluated trial related activities have been performed, and the records
were recorded, analyzed and accurately reported consistent with the protocol, sponsors SOPs,
GCP and the relevant regulatory necessities. (ICH GCP E6 1.6)
Audit Certificate - ANS-A statement of the affirmation by using the auditor that an audit has
taken location. (ICH GCP E6 1.7)
Audit Report - ANS-A written evaluation by using the sponsor's auditor of the results of the
audit. (ICH GCP E6 1.Eight)
Audit Trail - ANS-Documentation that permit reconstruction of the path of activities. (ICH GCP
E6 1.Nine)
Belmont Report - ANS-1979
Biometrics - ANS-A approach of verifying an individual's identity based totally on dimension of
the person's physical functions or repeatable moves wherein those capabilities and or
movements are both unique to that man or woman and measurable. (21 CFR, Sec. Eleven.3)
Blinding/Masking - ANS-A method wherein one or more parties to the trial are stored blind to the
treatment mission. (ICH GCP E6 1.10)
Case Report Form (CRF) - ANS-A printed, optical, or digital report designed to report all the
protocol required information to be said to the sponsor on each trial situation. (ICH GCP E6
1.Eleven)
Certification - ANS-The reputable notification by means of the group to the helping department
or agency, according with the necessities of this coverage, that a studies challenge or pastime
related to human topics has been reviewed and accepted by an IRB in accordance with an
accepted warranty. (forty five CFR, sec. 46.102)
Children - ANS-Persons who've now not attained the legal age for consent to treatment or
processes concerned in clinical investigations, beneath the applicable regulation of the
jurisdiction in which the scientific investigation might be conducted. (21 CFR, sec. 50.3)
