Clinical Trials - Good clinical practice Exam | Verified Exam Questions
and Answers | Latest Updated Study Material 2026
Question:
Clinical Trials - Good clinical practice Exam |Comprehensive
What is the role of the sponsor?
Answer:
- provide funds for the clinical
trials to take place
Question:
- They can be located all around the world
What is the role of the Principle Investigator?
Answer:
- They hold the
overall responsibility for the conduct of the trial
Question:
How do you define Good Clinical Practice? (GCP)
Answer:
an
international ethical and scientific quality standard for designing, conducting, recording and
reporting trials that involve the participation of human subjects.
Question:
Compliance with GCP provides:
Answer:
Compliance with this standard
provides public assurance that the rights, safety and well-being of trial subjects are protected,
consistent with the principles that have their origin in the Declaration of Helsinki, and that the
clinical trial data are credible.
Question:
Also creates a unified standard for different regulatory authorities to facilitate mutual acceptance
of clinical trial data
, It was developed by International Conference on Harmonisation
Why do we need GCP?
Answer:
because unethical human trials were
conducted before the declaration of helsinki
Question:
What is the declaration of Helsinki
Answer:
· Arose from Nuremberg
Code after World War II
Question:
· Set of ethical principles regarding human experimentation first developed in 1964 for the
medical community by the World Medical Association
· Cornerstone of human research ethics
· Not actually a legally binding instrument
· All trials should comply with Declaration voluntarily
Give examples of ICP GCP principles that serves a purpose for participants to be protected:
Answer:
ICH GCP Guideline 2.2
Question:
· " ... 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 "
ICH GCP Guideline 2.3
· " the rights, safety and well-being of the trial subjects are the most important considerations and
should prevail over interests of science and society "
ICH GCP Guideline 2.7
· " 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 "
Give examples of ICP GCP principles that talks about: Objectives, design, methodology,
statistical considerations and organisation of the trial are to be documented ie. the protocol
and Answers | Latest Updated Study Material 2026
Question:
Clinical Trials - Good clinical practice Exam |Comprehensive
What is the role of the sponsor?
Answer:
- provide funds for the clinical
trials to take place
Question:
- They can be located all around the world
What is the role of the Principle Investigator?
Answer:
- They hold the
overall responsibility for the conduct of the trial
Question:
How do you define Good Clinical Practice? (GCP)
Answer:
an
international ethical and scientific quality standard for designing, conducting, recording and
reporting trials that involve the participation of human subjects.
Question:
Compliance with GCP provides:
Answer:
Compliance with this standard
provides public assurance that the rights, safety and well-being of trial subjects are protected,
consistent with the principles that have their origin in the Declaration of Helsinki, and that the
clinical trial data are credible.
Question:
Also creates a unified standard for different regulatory authorities to facilitate mutual acceptance
of clinical trial data
, It was developed by International Conference on Harmonisation
Why do we need GCP?
Answer:
because unethical human trials were
conducted before the declaration of helsinki
Question:
What is the declaration of Helsinki
Answer:
· Arose from Nuremberg
Code after World War II
Question:
· Set of ethical principles regarding human experimentation first developed in 1964 for the
medical community by the World Medical Association
· Cornerstone of human research ethics
· Not actually a legally binding instrument
· All trials should comply with Declaration voluntarily
Give examples of ICP GCP principles that serves a purpose for participants to be protected:
Answer:
ICH GCP Guideline 2.2
Question:
· " ... 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 "
ICH GCP Guideline 2.3
· " the rights, safety and well-being of the trial subjects are the most important considerations and
should prevail over interests of science and society "
ICH GCP Guideline 2.7
· " 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 "
Give examples of ICP GCP principles that talks about: Objectives, design, methodology,
statistical considerations and organisation of the trial are to be documented ie. the protocol
