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Self-assessment (2)

2. True-False Question

Question 1

a) In Malaysia, the National Pharmaceutical Regulatory Agency (NPRA) is responsible for reviewing the safety information generated from both industry-sponsored and clinician-initiated drug trials.

Question 2


b) Whenever a serious adverse event (SAE) has occurred in a double-blinded study, you should unblind the intervention allocation for all subjects.

Question 3


c) A research subject who has experienced an adverse event should always be reviewed by a qualified medical professional.

Question 4


d) Research subjects should always be informed about investigation findings that relate to their own health.

Question 5


e) Only serious adverse events need to be documented and reported.