Definition

Inquiry to company medical information that may contain or lead to a reportable adverse event; must be triaged and referred to PV.

Example

HCP calls asking about dosing; mentions patient had rash—must be captured as AE.

Regulatory source

GVP Module VI, ICH E2D

Common mistakes

Medical information not forwarding potential AEs to PV.

Inspector question

How do you ensure medical information requests with AEs reach PV?

Related terms