Example: Simple Parallel Design

This is a simple study design example, including element start (TESTRL) and end (TEENRL) rules as well as element duration (TEDUR).

te.xpt

te.xpt

RowSTUDYIDDOMAINETCDELEMENTTESTRLTEENRLTEDUR
1EXP1TESCRNScreenStart of Pretreatment1 week after start of ElementP7D
2EXP1TETRT01Vehicle ControlFirst day of dosing with vehicle control28 days after start of ElementP28D
3EXP1TETRT02100 mg/kg Drug A, once dailyFirst day of dosing with 100 mg/kg Drug A28 days after start of ElementP28D
4EXP1TETRT03500 mg/kg Drug A, once dailyFirst day of dosing with 500 mg/kg Drug A28 days after start of ElementP28D
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Example: Study with a Nonfixed Duration Element

TOBA-213 - Getting issue details... STATUS

This example includes the nonfixed duration for pretest phase where the end rule is not a definite time, but when the subject achieves a specified body weight. In order to completely understand the experimental design of a trial, the TA and TS datasets are needed.

te.xpt

te.xpt

RowSTUDYIDDOMAINETCDELEMENTTESTRLTEENRLTEDUR
1EXP7TEPRETESTPretreatment Feeding PeriodStart of pre-exposure periodWhen subject's body weight is at least 750 g
2EXP7TECONTROLControl PeriodAfter completion of PRETEST Element30 days after start of ElementP30D
3EXP7TETREAT2100 mg/kg Drug A, once dailyAfter completion of PRETEST Element30 days after start of ElementP30D
4EXP7TETREAT3200 mg/kg Drug A, once dailyAfter completion of PRETEST Element30 days after start of ElementP30D
5EXP7TETREAT4300 mg/kg Drug A, once dailyAfter completion of PRETEST Element30 days after start of ElementP30D
6EXP7TETREAT5100 mg/kg Drug B, twice daily doses of 50 mg/kg eachAfter completion of PRETEST Element30 days after start of ElementP30D
7EXP7TETREAT6200 mg/kg Drug B, twice daily doses of 100 mg/kg eachAfter completion of PRETEST Element30 days after start of ElementP30D
8EXP7TETREAT7400 mg/kg Drug B, twice daily doses of 200 mg/kg eachAfter completion of PRETEST Element30 days after start of ElementP30D
9EXP7TERECOVERYRecovery PeriodAfter last dose with product or vehicle control14 days after start of ElementP14D
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« In vivo Trial Arms (TA) Domain Model

Additional Examples of In Vivo Trial Designs »

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