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In this example, the high-dose group originally scheduled to get 900 mg/kg was intentionally changed to 700 mg/kg after 1 week of the study. Prior to this change, a protocol amendment was created that altered the plan; therefore, this element would appear in TA, Trial Elements (TE), and SE.
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Row STUDYID DOMAIN USUBJID SESEQ ETCD ELEMENT SESTDTC SEENDTC 1 CDF2 SE CDF2-001 1 PRETEST Screen 2008-01-08 2008-01-14T07:00 2 CDF2 SE CDF2-001 2 TREATA Vehicle Control 2008-01-14T07:00 2008-01-27T09:00 3 CDF2 SE CDF2-001 3 RECOVERY Rest 2008-01-27T09:00 2008-02-02T07:00 4 CDF2 SE CDF2-010 1 PRETEST Screen 2008-01-08 2008-01-14T07:00 5 CDF2 SE CDF2-010 2 TREATB 100 mg/kg Drug A 2008-01-14T07:00 2008-01-27T09:30 6 CDF2 SE CDF2-010 3 RECOVERY Rest 2008-01-27T09:30 2008-02-02T07:00 7 CDF2 SE CDF2-020 1 PRETEST Screen 2008-01-08 2008-01-14T07:00 8 CDF2 SE CDF2-020 2 TREATC 300 mg/kg Drug A 2008-01-14T07:00 2008-01-27T10:30 9 CDF2 SE CDF2-020 3 RECOVERY Rest 2008-01-27T10:30 2008-02-02T07:00 10 CDF2 SE CDF2-030 1 PRETEST Screen 2008-01-08 2008-01-14T07:00 11 CDF2 SE CDF2-030 2 TREATD 900 mg/kg Drug A 2008-01-14T07:00 2008-01-21T07:00 12 CDF2 SE CDF2-030 3 TREATD2 700 mg/kg Drug A 2008-01-21T07:00 2008-01-27T09:30 13 CDF2 SE CDF2-030 4 RECOVERY Rest 2008-01-27T09:30 2008-02-02T07:00 14 CDF2 SE CDF2-040 1 PRETEST Screen 2008-01-08 2008-01-14T07:00 15 CDF2 SE CDF2-040 2 TREATE Positive Control Drug XY 2008-01-14T07:00 2008-01-27T10:30
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