Question

Adverse effects in clinical trials reported to

Answer 1

Answer:

Researchers participating in a clinical trial must report all adverse events to the drug regulatory authority of the respective country where the drug or device is to be registered [e.g. Food and Drug Administration (FDA) if it is US].

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Answer 2

Answer:

Safety analyses in clinical trials largely involve identifying untoward medical occurrences after exposure. These endpoints, which are not necessarily causally related, are called adverse events (or sometimes adverse effects).