Reference documents

Go to My Oracle Support (MOS) to access the following Electronic Technical Reference Manuals (eTRMs):
  • For more information on new Case Form fields, Console updates, usage of common profile switches, and configurations, see:
    • MIR Case Form Console Updates Summary.xlsx
    • Non-MIR Case Form Console Updates Summary.xlsx
  • For more information on export logic, new elements, mapping changes, allowed values, null flavors, conformance rules, data length, element number, and element description changes, see:
    • E2B (R3) Export Mappings.xlsx
    • MIR Export Mappings.xlsx
    • E2B (R2) 2.2 Export Mappings.xlsx
  • For ACK import logic, see the E2B (R3) Import Mappings sheet.

Note:

eTRMs are password-protected. Log a Service Request (SR) to obtain the password.

Go to the Oracle Help Center > Argus 8.2.2 Books page to access the following:

  • For more information on best practices to be followed for configuration of combination products or similar device combination products, case data entry, or report generation, and see:
    • South Korea MFDS E2B(R3) Best Practices
    • EC Manufacturer Incident Report (MIR) Best Practices
    • For E2B(R2) 2.2 profile, see to the CDER E2B(R2) Combination Product Best Practices
    • CBER eVAERS Combination Product Best Practices
  • For more information on the default service user names, see the Oracle Argus Safety Service Administration Guide.