“Always Expedited Reports”13
Given significant morbidity/mortality and known association with pharmaceuticals, questionnaires have been developed for some of these ADRs
Consensus query documents for use by any company suspecting occurrence of these ADRs?
Perceived need for development of
Clinically relevant, internationally accepted case definitions
Clinically relevant, internationally accepted series of questions designed to acquire optimal quality data for each of these serious ADRs ©sagcs 2007