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Always Expedited Reports13

  • 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

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