Question

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?

Answer 1

Answer:

Investigator Brochure

Answer 2

The source document that may not be used to determine whether an adverse event is expected or not in clinical studies in which investigational new drug is used is Annual Safety Report.

• The given question should have included the missing option which are:

    A. Investigator Brochure

    B. Protocol

    C. Informed Consent Form

    D. Annual Safety Report

    E. All of the above may be used

• Annual safety reports are the supplementary document of an investigational new drug which are updated every year based on findings of undergoing investigational new drug study.
• Expectedness is an outcome that is previously known and therefore stated in primary documents that are submitted before approval.
• It is stated in the clinical trial protocol, informed consent form, and investigator's brochure because they are the primary documents submitted to authorities before getting approval of clinical trial.
• Therefore, the Annual safety report is not used to determine the expected adverse event.