Which source document may NOT be used to determine whether an adverse event is expected or not in clinical studies in which an i

Question

Lostsunrise [7]

3 years ago

15

Which source document may NOT be used to determine whether an adverse event is expected or not in clinical studies in which an i

nvestigational new drug is used?

Medicine

1 answer:

saul85 [17] · Answer 1 · 2022-06-05T15:39:50+03:00

Answer: D. Annual Safety Report

Explanation:

The FDA requires that when there is a chance that an adverse effect might occur in a clinical trial, that it is included in certain documents.

It is to be included in an investigator brochure to ensure that the investigators are aware.

Protocol documents should also have the events disclosed and the the clinical participants should be aware of it in the Informed Consent Form that they sign.

An Annual Safety Report is not a primary source document in the first place so is the wrong option here.