ICH GCP for CCRC Exam Prep Questions And
Answers Verified 100% Correct
Investigator - ANSWER A person responsible for the conduct of the clinical trial at a
trial site.
Investigator's Brochure - ANSWER A compilation of the clinical and nonclinical data on
the investigational product(s) which is relevant to the study of the investigational
product(s) in human subjects.
Legally Acceptable Representative - ANSWER An individual or juridical or other body
authorized under applicable law to consent, on behalf of a prospective subject, to the
subject's participation in the clinical trial.
Monitoring - ANSWER The act of overseeing the progress of a clinical trial, and of
ensuring that it is conducted, recorded, and reported in accordance with the protocol,
Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the
applicable regulatory requirement(s).
Monitoring Report - ANSWER A written report from the monitor to the sponsor
after
each site visit and/or other trial-related communication according to the
sponsor's
SOPs.
Multicenter Trial - ANSWER A clinical trial conducted according to a single protocol
but
at more than one site, and therefore, carried out by more than one
investigator
Nonclinical Study - ANSWER Biomedical studies not performed on human subjects
IEC Opinion - ANSWER The judgement and/or the advice provided by an Independent
Ethics Committee (IEC)
Protocol - ANSWER A document that describes the objective(s), design, methodology,
statistical considerations, and organization of a trial.
Protocol Amendment - ANSWER A written description of a change to or formal
clarification of a protocol.
,Quality Assurance (QA) - ANSWER All those planned and systematic actions that are
established to ensure that the trial is performed ad the data are generated, documented,
and reported in compliance with GCP and the applicable regulatory requirements
Quality Control (QC) - ANSWER The operational techniques and activities undertaken
within the quality assurance system to verify that the requirements for quality of the
trialrelated activities have been fulfilled
Randomization - ANSWER The process of assigning trial subjects to treatment or
control groups using an element of chance to determine the assignments in order to
reduce bias.
Regulatory Authorities - ANSWER Bodies having the power to regulate.
Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR) -
ANSWER Any untoward medical occurrence that at any dose:
-results in death
-is life-threatening
-requires inpatient hospitalization or prolongation of existing hospitalization
-results in persistent or significant disability/incapacity
-is a congenital anomaly/birth defect
Source Data - ANSWER All information in original records and certified copies of
original records of clinical findings, observations, or other activities in a clinical trial
necessary for the reconstruction and evaluation of the trial
Source Documents - ANSWER Original documents, data, and records.
Sponsor - ANSWER An individual, company, institution, or organization which takes
responsibility for the initiation, management, and/or financing of a clinical trial
Sponsor-Investigator - ANSWER An individual who both initiates and conducts, alone
or with others, a clinical trial, and under whose immediate direction the investigational
product is administered to, dispensed to, or used by a subject.
Standard Operating Procedures (SOPs) - ANSWER Detailed, written instructions to
achieve uniformity of the performance of a specific function
Subinvestigator - 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/Trial Subject - ANSWER An individual who participates in a clinical trial, either
,as a recipient of the investigational product(s) or as a control
Subject Identification Code - 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
Trial Site - ANSWER The location(s) where trial-related activities are actually
conducted
Unexpected Adverse Drug Reaction - ANSWER An adverse reaction, the nature or
severity of which is not consistent with the applicable product information.
Vulnerable Subject - ANSWER Individuals whose willingness to volunteer in a clinical
trial may be unduly influenced by the expectation, whether justified or not, or benefits
associated with participation, or of a retaliatory response from senior members of a
hierarchy in case of refusal to participate.
Well-being (of the trial subjects) - ANSWER The physical and mental integrity of the
subjects participating in a clinical trial
E6(R1) 2 - ANSWER The Principles of ICH GCP
E6(R1) 2.1 - ANSWER Clinical trials should be conducted in accordance with the
ethical principles that have their origin in the Declaration of Helsinki, and that are
consistent with GCP and the applicable regulatory requirement(s)
E6(R1) 2.2 - ANSWER Before a trial is initiated, foreseeable risks and inconveniences
should be weighed against the anticipated benefit for the individual trial subject and
society. A trial should be initiated and continued only if the anticipated benefits justify
the risks.
E6(R1) 2.3 - ANSWER The rights, safety, and well-being of the trial subjects are the
most important considerations and should prevail over interests of science and society.
E6(R1) 2.4 - ANSWER The available nonclinical and clinical information on an
investigational product should be adequate to support the proposed clinical trial.
E6(R1) 2.5 - ANSWER Clinical trials should be scientifically sound, and described in a
clear detailed protocol.
E6(R1) 2.6 - ANSWER A trial should be conducted in compliance with the protocol that
has received prior institutional review board (IRB) approval/favorable opinion.
, E6(R1) 2.7 - ANSWER The medical care given to, and medical decisions made on
behalf of, subjects should always be the responsibility of a qualified physician or, when
appropriate, of a qualified dentist.
E6(R1) 2.8 - ANSWER Each individual involved in conducting a trial should be qualified
by eduction, training, and experience to perform his or her respective task(s).
E6(R1) 2.9 - ANSWER Freely given informed consent should be obtained from every
subject prior to clinical trial participation
E6(R1) 2.10 - ANSWER All clinical trial information should be recorded, handled, and
stored in a way that allows its accurate reporting interpretation and verification.
E6(R1) 2.11 - ANSWER The confidentiality of records that could identify subjects
should be protected, respecting the privacy and confidentiality rules in accordance with
the applicable regulatory requirement(s).
E6(R1) 2.12 - ANSWER Investigational products should be manufactured, handled,
and stored in accordance with applicable good manufacturing practice (GMP). They
should be used in accordance with the approved protocol.
E6(R1) 2.13 - ANSWER Systems with procedures that assure the quality of every
aspect of the trial should be implemented.
E6(R1) 3.1 - ANSWER Institutional Review Board/Independent Ethics Committee
(IRB/IEC)--Responsibilities
E6(R1) 3.2 - ANSWER Institutional Review Board/Independent Ethics Committee
(IRB/IEC)--Composition, Functions and Operations
E6(R1) 3.3 - ANSWER Institutional Review Board/Independent Ethics Committee
(IRB/IEC)--Procedures
-The IRB/IEC should establish, document in writing, and follow its procedures
E6(R1) 3.4 - ANSWER Institutional Review Board/Independent Ethics Committee
(IRB/IEC)--Records
-The IRB/IEC should retain all relevant records for a period of at least 3 years after
completion of the trial and make them available upon request from the regulatory
authorities
E6(R1) 3.1.1 - ANSWER An IRB/IEC should safeguard the rights, safety, and wellbeing
of all trial subjects. Special attention should be paid to trials that may include vulnerable
subjects
Answers Verified 100% Correct
Investigator - ANSWER A person responsible for the conduct of the clinical trial at a
trial site.
Investigator's Brochure - ANSWER A compilation of the clinical and nonclinical data on
the investigational product(s) which is relevant to the study of the investigational
product(s) in human subjects.
Legally Acceptable Representative - ANSWER An individual or juridical or other body
authorized under applicable law to consent, on behalf of a prospective subject, to the
subject's participation in the clinical trial.
Monitoring - ANSWER The act of overseeing the progress of a clinical trial, and of
ensuring that it is conducted, recorded, and reported in accordance with the protocol,
Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the
applicable regulatory requirement(s).
Monitoring Report - ANSWER A written report from the monitor to the sponsor
after
each site visit and/or other trial-related communication according to the
sponsor's
SOPs.
Multicenter Trial - ANSWER A clinical trial conducted according to a single protocol
but
at more than one site, and therefore, carried out by more than one
investigator
Nonclinical Study - ANSWER Biomedical studies not performed on human subjects
IEC Opinion - ANSWER The judgement and/or the advice provided by an Independent
Ethics Committee (IEC)
Protocol - ANSWER A document that describes the objective(s), design, methodology,
statistical considerations, and organization of a trial.
Protocol Amendment - ANSWER A written description of a change to or formal
clarification of a protocol.
,Quality Assurance (QA) - ANSWER All those planned and systematic actions that are
established to ensure that the trial is performed ad the data are generated, documented,
and reported in compliance with GCP and the applicable regulatory requirements
Quality Control (QC) - ANSWER The operational techniques and activities undertaken
within the quality assurance system to verify that the requirements for quality of the
trialrelated activities have been fulfilled
Randomization - ANSWER The process of assigning trial subjects to treatment or
control groups using an element of chance to determine the assignments in order to
reduce bias.
Regulatory Authorities - ANSWER Bodies having the power to regulate.
Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR) -
ANSWER Any untoward medical occurrence that at any dose:
-results in death
-is life-threatening
-requires inpatient hospitalization or prolongation of existing hospitalization
-results in persistent or significant disability/incapacity
-is a congenital anomaly/birth defect
Source Data - ANSWER All information in original records and certified copies of
original records of clinical findings, observations, or other activities in a clinical trial
necessary for the reconstruction and evaluation of the trial
Source Documents - ANSWER Original documents, data, and records.
Sponsor - ANSWER An individual, company, institution, or organization which takes
responsibility for the initiation, management, and/or financing of a clinical trial
Sponsor-Investigator - ANSWER An individual who both initiates and conducts, alone
or with others, a clinical trial, and under whose immediate direction the investigational
product is administered to, dispensed to, or used by a subject.
Standard Operating Procedures (SOPs) - ANSWER Detailed, written instructions to
achieve uniformity of the performance of a specific function
Subinvestigator - 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/Trial Subject - ANSWER An individual who participates in a clinical trial, either
,as a recipient of the investigational product(s) or as a control
Subject Identification Code - 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
Trial Site - ANSWER The location(s) where trial-related activities are actually
conducted
Unexpected Adverse Drug Reaction - ANSWER An adverse reaction, the nature or
severity of which is not consistent with the applicable product information.
Vulnerable Subject - ANSWER Individuals whose willingness to volunteer in a clinical
trial may be unduly influenced by the expectation, whether justified or not, or benefits
associated with participation, or of a retaliatory response from senior members of a
hierarchy in case of refusal to participate.
Well-being (of the trial subjects) - ANSWER The physical and mental integrity of the
subjects participating in a clinical trial
E6(R1) 2 - ANSWER The Principles of ICH GCP
E6(R1) 2.1 - ANSWER Clinical trials should be conducted in accordance with the
ethical principles that have their origin in the Declaration of Helsinki, and that are
consistent with GCP and the applicable regulatory requirement(s)
E6(R1) 2.2 - ANSWER Before a trial is initiated, foreseeable risks and inconveniences
should be weighed against the anticipated benefit for the individual trial subject and
society. A trial should be initiated and continued only if the anticipated benefits justify
the risks.
E6(R1) 2.3 - ANSWER The rights, safety, and well-being of the trial subjects are the
most important considerations and should prevail over interests of science and society.
E6(R1) 2.4 - ANSWER The available nonclinical and clinical information on an
investigational product should be adequate to support the proposed clinical trial.
E6(R1) 2.5 - ANSWER Clinical trials should be scientifically sound, and described in a
clear detailed protocol.
E6(R1) 2.6 - ANSWER A trial should be conducted in compliance with the protocol that
has received prior institutional review board (IRB) approval/favorable opinion.
, E6(R1) 2.7 - ANSWER The medical care given to, and medical decisions made on
behalf of, subjects should always be the responsibility of a qualified physician or, when
appropriate, of a qualified dentist.
E6(R1) 2.8 - ANSWER Each individual involved in conducting a trial should be qualified
by eduction, training, and experience to perform his or her respective task(s).
E6(R1) 2.9 - ANSWER Freely given informed consent should be obtained from every
subject prior to clinical trial participation
E6(R1) 2.10 - ANSWER All clinical trial information should be recorded, handled, and
stored in a way that allows its accurate reporting interpretation and verification.
E6(R1) 2.11 - ANSWER The confidentiality of records that could identify subjects
should be protected, respecting the privacy and confidentiality rules in accordance with
the applicable regulatory requirement(s).
E6(R1) 2.12 - ANSWER Investigational products should be manufactured, handled,
and stored in accordance with applicable good manufacturing practice (GMP). They
should be used in accordance with the approved protocol.
E6(R1) 2.13 - ANSWER Systems with procedures that assure the quality of every
aspect of the trial should be implemented.
E6(R1) 3.1 - ANSWER Institutional Review Board/Independent Ethics Committee
(IRB/IEC)--Responsibilities
E6(R1) 3.2 - ANSWER Institutional Review Board/Independent Ethics Committee
(IRB/IEC)--Composition, Functions and Operations
E6(R1) 3.3 - ANSWER Institutional Review Board/Independent Ethics Committee
(IRB/IEC)--Procedures
-The IRB/IEC should establish, document in writing, and follow its procedures
E6(R1) 3.4 - ANSWER Institutional Review Board/Independent Ethics Committee
(IRB/IEC)--Records
-The IRB/IEC should retain all relevant records for a period of at least 3 years after
completion of the trial and make them available upon request from the regulatory
authorities
E6(R1) 3.1.1 - ANSWER An IRB/IEC should safeguard the rights, safety, and wellbeing
of all trial subjects. Special attention should be paid to trials that may include vulnerable
subjects
