MODULE 2: GOOD CLINICAL
PRACTICE EXAM
What is Good Clinical Practice (GCP)? - Correct Answers -Global, scientific, and ethical
standard for conducting clinical research.
GCP protects... - Correct Answers -Subject safety and data integrity in a clinical trial.
GCP ensures... - Correct Answers -The results and data are credible and authentic. As
well as that there is no safety concerns related to any subjects enrolled.
ICH-GCP guidelines were devised based on - Correct Answers -Principles to protect the
sanctity of clinical trials.
Core Principles of ICH-GCP are:
Conduct clinical trials within... - Correct Answers -the ethical framework.
Core Principles of ICH-GCP are:
Conduct all details in the... - Correct Answers -Protocol associated with subjects, data,
and safety.
Core Principles of ICH-GCP are:
Ensure clinical care given to the subjects is through... - Correct Answers -Qualified
Physicians associated with the study.
Core Principles of ICH-GCP are:
Confidentiality of the.... - Correct Answers -Data and subject information should be
maintained properly.
Core Principles of ICH-GCP are:
Get approvals from... - Correct Answers -All Regulatory bodies.
-> Efficient evaluation of risk-benefit assessment of clinical trials.
-> No compromise on the rights, safety, and well being of subjects.
Core Principles of ICH-GCP are:
Ensure there is validated... - Correct Answers -Clinical and Non-Clinical information to
conduct the study.
Good Clinical Practice - Informed Consent:
Provide adequate information to... - Correct Answers -The subject to make a decision.
PRACTICE EXAM
What is Good Clinical Practice (GCP)? - Correct Answers -Global, scientific, and ethical
standard for conducting clinical research.
GCP protects... - Correct Answers -Subject safety and data integrity in a clinical trial.
GCP ensures... - Correct Answers -The results and data are credible and authentic. As
well as that there is no safety concerns related to any subjects enrolled.
ICH-GCP guidelines were devised based on - Correct Answers -Principles to protect the
sanctity of clinical trials.
Core Principles of ICH-GCP are:
Conduct clinical trials within... - Correct Answers -the ethical framework.
Core Principles of ICH-GCP are:
Conduct all details in the... - Correct Answers -Protocol associated with subjects, data,
and safety.
Core Principles of ICH-GCP are:
Ensure clinical care given to the subjects is through... - Correct Answers -Qualified
Physicians associated with the study.
Core Principles of ICH-GCP are:
Confidentiality of the.... - Correct Answers -Data and subject information should be
maintained properly.
Core Principles of ICH-GCP are:
Get approvals from... - Correct Answers -All Regulatory bodies.
-> Efficient evaluation of risk-benefit assessment of clinical trials.
-> No compromise on the rights, safety, and well being of subjects.
Core Principles of ICH-GCP are:
Ensure there is validated... - Correct Answers -Clinical and Non-Clinical information to
conduct the study.
Good Clinical Practice - Informed Consent:
Provide adequate information to... - Correct Answers -The subject to make a decision.
