Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

Dataset wrap
Namese
Dataset2
RowSTUDYIDDOMAINUSUBJIDSESEQETCDELEMENTSESTDTCSEENDTC
1ABC1SEABC1-0011SCRNScreen2008-01-082008-01-14
2ABC1SEABC1-0012GP 01Vehicle Control2008-01-152008-01-27
3ABC1SEABC1-0211SCRNScreen2008-01-082008-01-14
4ABC1SEABC1-0212GP 02100 mg/kg Drug Product A2008-01-152008-01-27
5ABC1SEABC1-0411SCRNScreen2008-01-082008-01-14
6ABC1SEABC1-0412GP 03500 mg/kg Drug Product A2008-01-152008-01-27

The following table is the corresponding Trial Arms (TA) dataset outlining the planned arms and elements for the same study. This is provided to assist with understanding how the actual experienced elements (SE dataset) relate to the planned arms defined here.

Dataset wrap
Nameta
Dataset2
RowSTUDYIDDOMAINARMCDARMTAETORDETCDELEMENTTABRANCHEPOCH
1ABC1TA01Control1SCRNScreenRandomized to Group 01Screen
2ABC1TA01Control2GP 01Vehicle Control
TreatmentExposure
3ABC1TA02100 mg/kg1SCRNScreenRandomized to Group 02Screen
4ABC1TA02100 mg/kg2GP 02100 mg/kg Drug Product A
TreatmentExposure
5ABC1TA03500 mg/kg1SCRNScreenRandomized to Group 03Screen
6ABC1TA03500 mg/kg2GP 03500 mg/kg Drug Product A
TreatmentExposure
Info

Note: This is a simple design where ARMCD relates directly to dose groups. In more complex designs, a separation between arms and groups may be required in naming conventions (e.g., "Randomized to Treatment Exposure 1").