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CCRC flashcards GCP Quiz with answers
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CCRC flashcards GCP Quiz with answers
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CCRC flashcards GCP QuizDo advertising materials need to be approved of by the IRB/IEC prior to distribution - correct answer
✔✔Yes
Which documents must be submitted to the IRB/IEC prior to the trial? - correct answer ✔✔The protocol
and the investigators brochure
What are expected or possible consequences of over-estimation of recruitment potential? - correct
answer ✔✔1- Running over the projected timeline due to difficulties in recruiting.
2-Multiple sites may be needed to be added to help with recruiting.
3-The study may be stopped due to lack of budget and there won't be the expected data produced in the
timeline projected.
Which of the following should be the first consideration when conducting a clinical trial - correct answer
✔✔Subject safety/welfare
When is the investigator allowed to deviate from the protocol? - correct answer ✔✔When there is a
hazard to the patient or subject.
Which conditions should be fulfilled when enrolling a subject into your trial? - correct answer ✔✔Do
they meet inclusion criteria and have they provided written informed consent.
When there is a reconsent or change in the Informed consent document for a trial the CRC/site needs to:
- correct answer ✔✔Reconsent all subjects and make them aware of any changes to the protocol.
What does "therapeutic misconception" mean? - correct answer ✔✔The subjects, patients, or
volunteers aren't receiving medical treatment for their condition. The study is for research only.
Who has ultimate trial responsibility for the each subject? - correct answer ✔✔The principal investigator
(PI)
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