Clinical Research Coordinator Exam Questions with
Correct Answers
ADR Correct Answer-Adverse Drug Reaction _ relationship between IP
and AE is at least reasonably possible
life threatening ADR reported to reg agencies within 7 days.
Unexpected Adverse drug Reaction Correct Answer-Severity not
consistent with IP information
Serious UAE (non life threatening) must be reported to regulators within
15 days.
seriousness vs severity Correct Answer-seriousness is based on outcome
usually life threat
Severity is intensity of specific event (severe headache)
SAE miniumum info Correct Answer-Pt Details
IP
Con Meds
SAE details
Reporter name
Sponsor details
Audit Correct Answer-systematic examination of a company's
accounting system to determine whether its financial reports reliably
represent its operations
,clinical trials Correct Answer-experiments that study the effectiveness of
medical treatments on Human Subjects
compliance Correct Answer-Adherence to all study related requirements
confidentiality Correct Answer-prevent (unauthorized) disclosure of pt
info OR sponsor info
Coordinating investigator Correct Answer-coordinates investigators at
different centers for a mulit-center trial.
Nonclinical Study Correct Answer-Biomedical studies not performed on
human subjects.
protocol Correct Answer-includes objective, design, methodology,
statistical considerations, and trial organization.
Regulatory Authorities Correct Answer-Bodies having the power to
regulate. In the ICH GCP guideline that guidelines the expression
Regulatory Authorities includes the authorities that review submitted
clinical data.
sponsor Correct Answer-takes responsibility for the initiation,
management, and/ or financing of a clinical trial
,Sponsor-Investigator Correct 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)
Subinvestigator Correct Answer-Any individual member of the clinical
trial team designated and supervised by the investigator at a trial site to
perform critical trial-related procedures and/or to make important trial-
related decisions.
Subject Identification Code Correct Answer-A unique identifier assigned
by the investigator to each trial subject to protect the subject's identity
and used in lieu of the subject's name when the investigator reports
adverse events and/or other trial related data.
Vulnerable Subjects Correct Answer-Individuals whose willingness to
volunteer in a clinical trial may be unduly influenced by the expectation,
whether justified or not, of benefits associated with participation, or of a
retaliatory response from senior members of a hierarchy in case of
refusal to participate. Examples are members of a group with a
hierarchical structure, such as medical, pharmacy, dental, and nursing
students, subordinate hospital and laboratory personnel, employees of
the pharmaceutical industry, members of the armed forces, and persons
kept in detention. Other vulnerable subjects include patients with
incurable diseases, persons in nursing homes, unemployed or
impoverished persons, patients in emergency situations, ethnic minority
groups, homeless persons, nomads, refugees, minors, and those
incapable of giving consent.
, Monitoring Plan Correct Answer-A document that describes the
strategy, methods, responsibilities, and requirements for monitoring the
trial.
Validation of Computerized Systems Correct Answer-A process of
establishing and documenting that the specified requirements of a
computerized system can be consistently fulfilled from design until
decommissioning of the system or transition to a new system. The
approach to validation should be based on a risk assessment that takes
into consideration the intended use of the system and the potential of the
system to affect human subject protection and reliability of trial results.
ICH GCP Principles Correct Answer-2.1-2.13
Use ethics of Declaration of Helsinki
pt safety, clinically sound, informed consent, documented,
confidentiality, IP use
ICH IRB responsibilities Correct Answer-3.1.1-3.1.9
Subjects
documents (ICF, IB , Safety, Payments, PI CV)
Continual review (at least annual)
IRB composition Correct Answer-No vested interest in the study or
outcomes. At least 5 members (at least 1 scientist, at least 1 non-
scientist, at least 1 person not affiliated with institution)
Correct Answers
ADR Correct Answer-Adverse Drug Reaction _ relationship between IP
and AE is at least reasonably possible
life threatening ADR reported to reg agencies within 7 days.
Unexpected Adverse drug Reaction Correct Answer-Severity not
consistent with IP information
Serious UAE (non life threatening) must be reported to regulators within
15 days.
seriousness vs severity Correct Answer-seriousness is based on outcome
usually life threat
Severity is intensity of specific event (severe headache)
SAE miniumum info Correct Answer-Pt Details
IP
Con Meds
SAE details
Reporter name
Sponsor details
Audit Correct Answer-systematic examination of a company's
accounting system to determine whether its financial reports reliably
represent its operations
,clinical trials Correct Answer-experiments that study the effectiveness of
medical treatments on Human Subjects
compliance Correct Answer-Adherence to all study related requirements
confidentiality Correct Answer-prevent (unauthorized) disclosure of pt
info OR sponsor info
Coordinating investigator Correct Answer-coordinates investigators at
different centers for a mulit-center trial.
Nonclinical Study Correct Answer-Biomedical studies not performed on
human subjects.
protocol Correct Answer-includes objective, design, methodology,
statistical considerations, and trial organization.
Regulatory Authorities Correct Answer-Bodies having the power to
regulate. In the ICH GCP guideline that guidelines the expression
Regulatory Authorities includes the authorities that review submitted
clinical data.
sponsor Correct Answer-takes responsibility for the initiation,
management, and/ or financing of a clinical trial
,Sponsor-Investigator Correct 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)
Subinvestigator Correct Answer-Any individual member of the clinical
trial team designated and supervised by the investigator at a trial site to
perform critical trial-related procedures and/or to make important trial-
related decisions.
Subject Identification Code Correct Answer-A unique identifier assigned
by the investigator to each trial subject to protect the subject's identity
and used in lieu of the subject's name when the investigator reports
adverse events and/or other trial related data.
Vulnerable Subjects Correct Answer-Individuals whose willingness to
volunteer in a clinical trial may be unduly influenced by the expectation,
whether justified or not, of benefits associated with participation, or of a
retaliatory response from senior members of a hierarchy in case of
refusal to participate. Examples are members of a group with a
hierarchical structure, such as medical, pharmacy, dental, and nursing
students, subordinate hospital and laboratory personnel, employees of
the pharmaceutical industry, members of the armed forces, and persons
kept in detention. Other vulnerable subjects include patients with
incurable diseases, persons in nursing homes, unemployed or
impoverished persons, patients in emergency situations, ethnic minority
groups, homeless persons, nomads, refugees, minors, and those
incapable of giving consent.
, Monitoring Plan Correct Answer-A document that describes the
strategy, methods, responsibilities, and requirements for monitoring the
trial.
Validation of Computerized Systems Correct Answer-A process of
establishing and documenting that the specified requirements of a
computerized system can be consistently fulfilled from design until
decommissioning of the system or transition to a new system. The
approach to validation should be based on a risk assessment that takes
into consideration the intended use of the system and the potential of the
system to affect human subject protection and reliability of trial results.
ICH GCP Principles Correct Answer-2.1-2.13
Use ethics of Declaration of Helsinki
pt safety, clinically sound, informed consent, documented,
confidentiality, IP use
ICH IRB responsibilities Correct Answer-3.1.1-3.1.9
Subjects
documents (ICF, IB , Safety, Payments, PI CV)
Continual review (at least annual)
IRB composition Correct Answer-No vested interest in the study or
outcomes. At least 5 members (at least 1 scientist, at least 1 non-
scientist, at least 1 person not affiliated with institution)
