PIVOT QUIZ - GOOD CLINICAL
PRACTICE UPDATED ACTUAL
Questions and CORRECT Answers
NOT a principle of GCP: - CORRECT ANSWER - Publication of results is not required if
the study results were not as expected.
ICH-GCP guidelines are a legal requirement and studies found not following it will be
terminated. - CORRECT ANSWER - False
It is important for investigators in low-and middle-income countries to adopt good clinical
practice guidelines because their studies will consequently be recognised as being of the same
standard as other GCP compliant studies across the globe. - CORRECT ANSWER - True
Which of the following is NOT true about the informed consent process: (Please select all that
apply) - CORRECT ANSWER - IEC/IRB approval must be gained for all participant
related materials and documents.
Details of any alternative treatments/options must be given to participants after they have given
consent
Consent must be given freely without coercion or undue influence.
A participant can withdraw from the study at any time without providing a reason.
If the participant cannot read or write the consent form can be marked/signed at any time during
participation as long as the participant has agreed to join the study.
As long as you document the entire process, you can unblind a participant at the request of a site
investigator who wants to enter the participant into another study. - CORRECT
ANSWER - False
PRACTICE UPDATED ACTUAL
Questions and CORRECT Answers
NOT a principle of GCP: - CORRECT ANSWER - Publication of results is not required if
the study results were not as expected.
ICH-GCP guidelines are a legal requirement and studies found not following it will be
terminated. - CORRECT ANSWER - False
It is important for investigators in low-and middle-income countries to adopt good clinical
practice guidelines because their studies will consequently be recognised as being of the same
standard as other GCP compliant studies across the globe. - CORRECT ANSWER - True
Which of the following is NOT true about the informed consent process: (Please select all that
apply) - CORRECT ANSWER - IEC/IRB approval must be gained for all participant
related materials and documents.
Details of any alternative treatments/options must be given to participants after they have given
consent
Consent must be given freely without coercion or undue influence.
A participant can withdraw from the study at any time without providing a reason.
If the participant cannot read or write the consent form can be marked/signed at any time during
participation as long as the participant has agreed to join the study.
As long as you document the entire process, you can unblind a participant at the request of a site
investigator who wants to enter the participant into another study. - CORRECT
ANSWER - False
