You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 5 Next »

Example: Parallel Design

In this example, subjects ABC1-001, ABC1-021, and ABC1-041 all experienced their planned sequence of elements. The SE dataset documents the start and end dates of each element.

se.xpt

se.xpt

RowSTUDYIDDOMAINUSUBJIDSESEQETCDELEMENTSESTDTCSEENDTC
1ABC1SEABC1-0011SCRNScreen2008-01-082008-01-14
2ABC1SEABC1-0012GP 01Control2008-01-152008-01-27
3ABC1SEABC1-0211SCRNScreen2008-01-082008-01-14
4ABC1SEABC1-0212GP 02100 mg/kg Product A2008-01-152008-01-27
5ABC1SEABC1-0411SCRNScreen2008-01-082008-01-14
6ABC1SEABC1-0412GP 03500 mg/kg Product A2008-01-152008-01-27
$warningHtml
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.

ta.xpt

ta.xpt

RowSTUDYIDDOMAINARMCDARMTAETORDETCDELEMENTTABRANCHEPOCH
1ABC1TA01Control1SCRNScreenRandomized to Group 01Screen
2ABC1TA01Control2GP 01Control
Exposure
3ABC1TA02100 mg/kg1SCRNScreenRandomized to Group 02Screen
4ABC1TA02100 mg/kg2GP 02100 mg/kg Product A
Exposure
5ABC1TA03500 mg/kg1SCRNScreenRandomized to Group 03Screen
6ABC1TA03500 mg/kg2GP 03500 mg/kg Product A
Exposure
$warningHtml

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 Exposure 1").

Example: Parallel Design

Unable to render {include} The included page could not be found.

Example: Mis-dosing of an animal

Unable to render {include} The included page could not be found.

Example: High Dose Changed from 900 mg/kg to 700 mg/kg

Unable to render {include} The included page could not be found.

  • No labels