Which document is used to determine the expectedness of an ADR?

• A. Informed Consent Form
• B. Investigator's Brochure and labeling
• C. Protocol
• D. Data Safety Monitoring Board Charter

Answer: (B)

Expectedness of an adverse drug reaction is determined by whether the event is already listed in the drug’s safety information. The Investigator’s Brochure provides the compiled safety data from prior studies and experience, including which adverse events have been observed and how often they occur. The labeling (the approved product labeling) also lists known adverse events and their frequencies. If an adverse event that occurs during the trial is described in either the Investigator’s Brochure or the labeling, it is considered expected; if it’s not listed there, it’s considered unexpected and may require expedited reporting as a SUSAR.

Informed consent describes risks to participants but does not determine expectedness. The protocol outlines how the study is conducted, not which events are expected. The Data Safety Monitoring Board Charter covers safety oversight procedures, not the determination of expectedness.