1 what are cosmetovigilance requirements a all adverse...

1. What are Cosmetovigilance requirements: a. all adverse events have to be reported to authorities b. adverse events have to be monitored, only serious undesirable effects have to be reported c. there are no specific requirements.

Transcript

00:01 Okay, today we're going to be talking about some psychology.

00:05 So let's do one, two, three, four, and five.

00:12 So question number one, which adverse features not used to determine whether expedited reporting to the fda by the sponsors required until an adverse event is when there is an underlying clinical outcome when a person's, so the one that would not be used would be your expectiveness because expectiveness is associated with events that have known adverse effects of specific indications.

00:53 The other aspects, seriousness, causal relationship, and severity are all used to determine expedited reporting to the fda.

01:09 To which source document may not be used to determine whether an adverse event is expected or not in clinical studies in which an investigational new drug is used.

01:22 The correct here is going to be your safety report, which is d.

01:25 Your safety report tells you how safe the pharmaceutical product or the drug is.

01:37 An investigation, investigative brochure protocol informed consent form.

01:42 Would all be used.

01:47 Three, the site investigator receives a copy of an expedited safety form that represents an increased risk to the safety participants.

01:56 So what you would do is you would have to report it to your local irb, your internal review board, because they are the ones that make sure that the clinical trial remains safe for all participants.

02:13 So since there's an increased risk, you would need to report it to them...

Question

1. What are Cosmetovigilance requirements: a. all adverse events have to be reported to authorities b. adverse events have to be monitored, only serious undesirable effects have to be reported c. there are no specific requirements.

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