CCRC Module 3: GCP for the
Experienced Clinical Research
Professional Exam Questions and
Answers 100% PASS
The ICH for GCP describes the responsibilities of these 4 groups: - CORRECT
ANSWER-Sponsors
Investigators
Institutional Review Boards
Independent Ethics Committees
The International Council on Harmonisation Guidelines for Good Clinical Practice
describes the responsibilities of sponsors, investigators, and institutional review
boards, as well as independent ethics committees in order to: [2 Reasons] -
CORRECT ANSWER-1. Safeguard the safery and well-being of trial subjects.
2. Ensure the scientific integrity of the study data.
,Per this ICH guideline, the conduct of any clinical research trial is ultimately the
responsibility of the ___. - CORRECT ANSWER-Per ICH E6, the investigator
has full responsibility.
The investigator can ___ various trial related duties and tasks to any qualified staff
in order to ensure good ____ _____. - CORRECT ANSWER-Delegate; good trial
conduct.
In order to ensure good trial conduct, the investigator may delegate various trial
tasks and duties presented in this guideline to any qualified staff. Qualified staff
could include: - CORRECT ANSWER-Clinical research coordinators, clinical
research nurses, clinical trial assistants, pharmacists, etc.
Investigator(s) should be qualified by education, training, and __ to assume
responsibility for the proper conduct of the trial, meet all qualifications specified
by the applicable regulatory requirement(s), and provide evidence through up-to-
date curriculum vitae and/or other relevant documentation. - CORRECT
ANSWER-Experience
The investigator and ____ should permit monitoring and auditing by the sponsor,
and inspection by the appropriate regulatory authority(ies). - CORRECT
ANSWER-Institution
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,The investigator and institution should permit monitoring and auditing by the
_____, and inspection by the appropriate ___. - CORRECT ANSWER-Sponsor;
Regulatory Authorities
It is recommended that the investigator inform the subject's ___ about the
subject's participation in the trial if the subject has a _____ and if the subject
agrees to the ____ being informed. - CORRECT ANSWER-Primary physician
Although a subject is not obliged to give his/her reasons for prematurely
withdrawing from a trial, the investigator should make a reasonable effort to
ascertain the reason(s), while fully respecting the subject's ____. - CORRECT
ANSWER-Rights
Where allowed/required, the investigator/institution may/should assign some or
all of the investigator's/institution's __ for investigational product(s) accountability
at the trial site(s) to an appropriate pharmacist/appropriate individual who's under
the supervision of the investigator/institution. - CORRECT ANSWER-Duties
Neither the investigator, nor the trial staff, should coerce or unduly ____ a subject
to participate or to continue to participate in a trial. - CORRECT ANSWER-
Influence
The investigator/person they designated, should fully inform the subject or, if the
subject is __ to provide informed consent, the subject's legally acceptable
representative, of all pertinent aspects of the trial including the written information
, and the approval/ favorable opinion by the IRB/IEC. - CORRECT ANSWER-
Unable.
The language used in the oral and written information about the trial, including the
written informed consent form, should be as non-technical as practical and should
be ___ to the subject or the subject's legally acceptable representative and the
impartial witness, where applicable. - CORRECT ANSWER-Understandable
The investigator should ___ written summaries of the trial status to the IRB/IEC
annually, or more frequently, if requested by the IRB/IEC. - CORRECT
ANSWER-Submit
The ___ should submit written summaries of the trial status to the ___ annually, or
more frequently, if requested by the ___. - CORRECT ANSWER-Investigator;
IRB/IEC
All ___ adverse events should be reported immediately to the Sponsor except for
those that the protocol or other document (e.g., Investigator's Brochure) identifies
as not needing immediate reporting. The immediate reports should be followed
promptly by ____. - CORRECT ANSWER-Serious; Detailed, written reports.
Immediate/follow-up reports should ID subjects by their unique trial code
numbers rather than their name, ID numbers, and/or addresses. The investigator
should also comply with the applicable __ requirement(s) related to the reporting
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
Experienced Clinical Research
Professional Exam Questions and
Answers 100% PASS
The ICH for GCP describes the responsibilities of these 4 groups: - CORRECT
ANSWER-Sponsors
Investigators
Institutional Review Boards
Independent Ethics Committees
The International Council on Harmonisation Guidelines for Good Clinical Practice
describes the responsibilities of sponsors, investigators, and institutional review
boards, as well as independent ethics committees in order to: [2 Reasons] -
CORRECT ANSWER-1. Safeguard the safery and well-being of trial subjects.
2. Ensure the scientific integrity of the study data.
,Per this ICH guideline, the conduct of any clinical research trial is ultimately the
responsibility of the ___. - CORRECT ANSWER-Per ICH E6, the investigator
has full responsibility.
The investigator can ___ various trial related duties and tasks to any qualified staff
in order to ensure good ____ _____. - CORRECT ANSWER-Delegate; good trial
conduct.
In order to ensure good trial conduct, the investigator may delegate various trial
tasks and duties presented in this guideline to any qualified staff. Qualified staff
could include: - CORRECT ANSWER-Clinical research coordinators, clinical
research nurses, clinical trial assistants, pharmacists, etc.
Investigator(s) should be qualified by education, training, and __ to assume
responsibility for the proper conduct of the trial, meet all qualifications specified
by the applicable regulatory requirement(s), and provide evidence through up-to-
date curriculum vitae and/or other relevant documentation. - CORRECT
ANSWER-Experience
The investigator and ____ should permit monitoring and auditing by the sponsor,
and inspection by the appropriate regulatory authority(ies). - CORRECT
ANSWER-Institution
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
,The investigator and institution should permit monitoring and auditing by the
_____, and inspection by the appropriate ___. - CORRECT ANSWER-Sponsor;
Regulatory Authorities
It is recommended that the investigator inform the subject's ___ about the
subject's participation in the trial if the subject has a _____ and if the subject
agrees to the ____ being informed. - CORRECT ANSWER-Primary physician
Although a subject is not obliged to give his/her reasons for prematurely
withdrawing from a trial, the investigator should make a reasonable effort to
ascertain the reason(s), while fully respecting the subject's ____. - CORRECT
ANSWER-Rights
Where allowed/required, the investigator/institution may/should assign some or
all of the investigator's/institution's __ for investigational product(s) accountability
at the trial site(s) to an appropriate pharmacist/appropriate individual who's under
the supervision of the investigator/institution. - CORRECT ANSWER-Duties
Neither the investigator, nor the trial staff, should coerce or unduly ____ a subject
to participate or to continue to participate in a trial. - CORRECT ANSWER-
Influence
The investigator/person they designated, should fully inform the subject or, if the
subject is __ to provide informed consent, the subject's legally acceptable
representative, of all pertinent aspects of the trial including the written information
, and the approval/ favorable opinion by the IRB/IEC. - CORRECT ANSWER-
Unable.
The language used in the oral and written information about the trial, including the
written informed consent form, should be as non-technical as practical and should
be ___ to the subject or the subject's legally acceptable representative and the
impartial witness, where applicable. - CORRECT ANSWER-Understandable
The investigator should ___ written summaries of the trial status to the IRB/IEC
annually, or more frequently, if requested by the IRB/IEC. - CORRECT
ANSWER-Submit
The ___ should submit written summaries of the trial status to the ___ annually, or
more frequently, if requested by the ___. - CORRECT ANSWER-Investigator;
IRB/IEC
All ___ adverse events should be reported immediately to the Sponsor except for
those that the protocol or other document (e.g., Investigator's Brochure) identifies
as not needing immediate reporting. The immediate reports should be followed
promptly by ____. - CORRECT ANSWER-Serious; Detailed, written reports.
Immediate/follow-up reports should ID subjects by their unique trial code
numbers rather than their name, ID numbers, and/or addresses. The investigator
should also comply with the applicable __ requirement(s) related to the reporting
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
