Message and Acknowledgement Profiles

Oracle Argus Interchange Mapping provides the following standard Message and Acknowledgement profiles:

  • CBER EVAERS V1.0 MESSAGE TEMPLATE
  • CDRH EMDR V1.0 MESSAGE TEMPLATE
  • EC-MIR MESSAGE TEMPLATE
  • ICH-ICSR V1.1 ACKNOWLEDGMENT TEMPLATE
  • ICH-ICSR V1.1 ACKNOWLEDGMENT TEMPLATE - FDA
  • ICH-ICSR V1.1 ACKNOWLEDGMENT TEMPLATE - EMA
  • ICH-ICSR V1.1 ACKNOWLEDGMENT TEMPLATE - PMDA
  • ICH-ICSR V2.1 MESSAGE TEMPLATE
  • ICH-ICSR V2.1 MESSAGE TEMPLATE - EMA
  • ICH-ICSR V2.1 MESSAGE TEMPLATE - FDA
  • ICH-ICSR V2.1 MESSAGE TEMPLATE - PMDA - I
  • ICH-ICSR V2.1 MESSAGE TEMPLATE - PMDA - J
  • ICH-ICSR V2.1 MESSAGE TEMPLATE - FDA PIP
  • ICH-ICSR V2.1 MESSAGE TEMPLATE - PMDA PIP
  • ICH-ICSR V2.2 MESSAGE TEMPLATE - FDA
  • ICH-ICSR V3.0 ACKNOWLEDGMENT TEMPLATE - ICH
  • ICH-ICSR V3.0 ACKNOWLEDGMENT TEMPLATE - EMA
  • ICH-ICSR V3.0 ACKNOWLEDGMENT TEMPLATE - PMDA
  • ICH-ICSR V3.0 MESSAGE TEMPLATE
  • ICH-ICSR V3.0 MESSAGE TEMPLATE - EMA
  • ICH-ICSR V3.0 MESSAGE TEMPLATE - MFDS
  • ICH-ICSR V3.0 MESSAGE TEMPLATE -NMPA
  • ICH-ICSR V3.0 MESSAGE TEMPLATE - PMDA
  • PMDA-DEVICE MESSAGE TEMPLATE

For more information, see: