Example of a Study with a Nonfixed Duration Element

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.

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