ICH Guidelines - For CRC Certification Exam Questions with 100%
Correct Answers Latest Graded A+
Question:
Good Clinical Practice (GCP)
Answer:
is an international ethical and scientific
quality standard for designing, conducting, recording and reporting trials that involve the
participation of human subjects.
Question:
Clinical trials should be..
Answer:
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).
Question:
Before a trial is initiated, foreseeable risks and inconveniences should be
Answer:
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.
Question:
The rights, safety, and well-being of the trial subjects are the most important considerations and
should
Answer:
Prevail over interests of science and
society.
Question:
, The available nonclinical and clinical information on an investigational product should be
Answer:
Adequate to support the proposed clinical trial.
Question:
Clinical trials should be
Answer:
Scientifically sound, and described in a clear,
detailed protocol.
Question:
A trial should be
Answer:
Conducted in compliance with the protocol that has
received prior institutional review board (IRB)/independent ethics
committee (IEC) approval/favourable opinion.
Question:
The medical care given to, and medical decisions made on behalf of, subjects should always be
Answer:
The responsibility of a qualified physician or,when appropriate, of a qualified dentist.
Question:
Each individual involved in conducting a trial should be
Answer:
Qualified by education, training, and experience to perform his or her respective task(s).
Question:
Freely given informed consent should be
Answer:
Obtained from every subject prior
Correct Answers Latest Graded A+
Question:
Good Clinical Practice (GCP)
Answer:
is an international ethical and scientific
quality standard for designing, conducting, recording and reporting trials that involve the
participation of human subjects.
Question:
Clinical trials should be..
Answer:
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).
Question:
Before a trial is initiated, foreseeable risks and inconveniences should be
Answer:
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.
Question:
The rights, safety, and well-being of the trial subjects are the most important considerations and
should
Answer:
Prevail over interests of science and
society.
Question:
, The available nonclinical and clinical information on an investigational product should be
Answer:
Adequate to support the proposed clinical trial.
Question:
Clinical trials should be
Answer:
Scientifically sound, and described in a clear,
detailed protocol.
Question:
A trial should be
Answer:
Conducted in compliance with the protocol that has
received prior institutional review board (IRB)/independent ethics
committee (IEC) approval/favourable opinion.
Question:
The medical care given to, and medical decisions made on behalf of, subjects should always be
Answer:
The responsibility of a qualified physician or,when appropriate, of a qualified dentist.
Question:
Each individual involved in conducting a trial should be
Answer:
Qualified by education, training, and experience to perform his or her respective task(s).
Question:
Freely given informed consent should be
Answer:
Obtained from every subject prior
