PIVOT QUIZ - GOOD CLINICAL PRACTICE QUESTIONS
WITH VERIFIED ANSWERS|| LATEST UPDATED
1. NOT a principle of GCP:: Publication of results is not required if the study results
were not as expected.
2. ICH-GCP guidelines are a legal requirement and studies found not following
it will be terminated.: False
3. 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.: True
4. Which of the following is NOT true about the informed consent process:
(Please select all that apply): 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.
5. 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.: False
6. Participants in a study with an investigational medicinal product should
only contact the study physician if feeling unwell if their own physician is
unavailable.: False
7. Approval from the IEC/IRB is not required for which of the following:: Study
management plan
Study protocol
WITH VERIFIED ANSWERS|| LATEST UPDATED
1. NOT a principle of GCP:: Publication of results is not required if the study results
were not as expected.
2. ICH-GCP guidelines are a legal requirement and studies found not following
it will be terminated.: False
3. 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.: True
4. Which of the following is NOT true about the informed consent process:
(Please select all that apply): 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.
5. 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.: False
6. Participants in a study with an investigational medicinal product should
only contact the study physician if feeling unwell if their own physician is
unavailable.: False
7. Approval from the IEC/IRB is not required for which of the following:: Study
management plan
Study protocol
