Chapter 18 MCQs

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. Which of the following dates in the history of clinical trials is INCORRECT?

First recorded clinical trial in 1747 correct incorrect

First use of placebos in clinical trials in 1863 correct incorrect

First randomized clinical trial in 1923 correct incorrect

First multi-centre clinical trial in 1958 correct incorrect

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. Which of the following is NOT included in the ICH quality guidelines?

Stability studies correct incorrect

Reproductive toxicity studies correct incorrect

Impurity testing correct incorrect

Good manufacturing practice (GMP) correct incorrect

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. Which of the following bodies was NOT involved as a founder member of the International Conference on Harmonisation (ICH)?

The World Health Organization (WHO) correct incorrect

European Federation of Pharmaceutical Industries and Associations correct incorrect

European Commission correct incorrect

Japanese Pharmaceutical Manufacturers Association correct incorrect

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. Which of the following is NOT associated with Phase 0 clinical trials?

Confirmation of pre-clinical studies correct incorrect

Sub-clinical doses correct incorrect

~ 100 participants correct incorrect

Healthy volunteers correct incorrect

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. Which of the following is NOT associated with Phase 1 clinical trials?

~ 100 participants correct incorrect

Patients with target disease correct incorrect

Establishment of safety of drug in humans correct incorrect

Establishment of normal human dosage correct incorrect

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. Which of the following is NOT associated with Phase 2 clinical trials?

Patients with target condition correct incorrect

Placebo-controlled trial correct incorrect

Monitoring of side effects correct incorrect

Thousands of participants correct incorrect

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. Which of the following is NOT associated with Phase 3 clinical trials?

Patients with target condition correct incorrect

Monitoring of long-term safety correct incorrect

Comparison with an existing treatment correct incorrect

Thousands of participants correct incorrect

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. Which of the following is NOT associated with Phase 4 clinical trials?

Monitoring of long-term safety correct incorrect

A mixture of populations involved correct incorrect

Also known as post-marketing surveillance correct incorrect

Small numbers of participants correct incorrect

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. Which of the following sources does NOT provide Individual Case Safety Reports (ICSRs)?

Pharmaceutical companies correct incorrect

Clinical Research Organizations correct incorrect

Individual patients correct incorrect

Regulatory agencies correct incorrect

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. Which of the following is NOT one of the principles of Good Clinical Practice (GCP)?

The well-being of subjects is of highest priority. correct incorrect

Trials should have a clear, defined protocol. correct incorrect

Informed consent of subjects must be obtained. correct incorrect

The protocol is approved by the trial organization. correct incorrect