2. True-False Question
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True
This is true. The NPRA reviews the safety information of both new and registered drugs from clinical drug trials, whether industry-sponsored or clinician-initiated.
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False
This is false. Unblinding should be performed when knowledge about the intervention allocation will affect the management or treatment of a subject. It is not compulsory if subjects would be treated in the same manner regardless of which intervention they had received.
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True
This is true. If a research team does not have the competency to review a subject’s condition properly, the team should refer the subject to a qualified clinician who can investigate the AE and provide appropriate care or treatment.
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False
This is false. You should use your medical and scientific judgement to decide whether to alarm a subject to such findings. Some research findings may be of uncertain significance and could lead to unnecessary anxiety.
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False
This is false. All adverse events whether minor or serious have to be documented. Non-serious adverse events may still need to be reported periodically, or urgently if they are occurring at a high rate.