4 Case type criteria

The following types of cases and criteria need to be met:

Cases Criteria
KR case (Domestic Post Marketed)
  • cases that have REPORTTYPE [C.1.3] = 2, OBSERVESTUDYTYPE [C.5.4] = 3 and REPORTERCOUNTRYR3 [C.2.r.3] for Primary Reporter = KR
  • cases that have REPORTTYPE [C.1.3] <> 2 and REPORTERCOUNTRYR3 [C.2.r.3] for Primary Reporter = KR
FR case (Foreign Post Marketed)
  • cases that have REPORTTYPE [C.1.3] = 2, OBSERVESTUDYTYPE [C.5.4] = 3 and REPORTERCOUNTRYR3 [C.2.r.3] for Primary Reporter <> KR
  • cases that have REPORTTYPE [C.1.3] <> 2 and REPORTERCOUNTRYR3 [C.2.r.3] for Primary Reporter <> KR
CT case (Clinical Trial Domestic)
  • cases that have REPORTTYPE [C.1.3] = 2, OBSERVESTUDYTYPE [C.5.4] = 1 and REPORTERCOUNTRYR3 [C.2.r.3] for Primary Reporter = KR
CF case (Clinical Trial Foreign)
  • cases that have REPORTTYPE [C.1.3] = 2, OBSERVESTUDYTYPE [C.5.4] = 1 and REPORTERCOUNTRYR3 [C.2.r.3] for Primary Reporter <> KR
CU case (Compassionate Use)
  • cases that have REPORTTYPE [C.1.3] = 2 and OBSERVESTUDYTYPE [C.5.4] = 2

You can customize the criteria to determine the case type to be KR/FR/CT/CF/CU by updating the PKG_MFDS.f_get_Case_Type database function code in the ESM schema. For example, you can update this function if you want to determine whether the case type for a case containing a study is PM or CT. You can achieve this by adding an additional condition to check the Study Registration Number assigned for Korea.