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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-213 |
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| Excerpt |
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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 (see Section 7.3, Trial Arms, and Section 7.4, Trial Sets).
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| Dataset2 |
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| Row | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
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| 1 | EXP7 | TE | PRETEST | Pretreatment Feeding Period | Start of pretreatment pre-exposure period | When subject's body weight is at least 750 g |
| | 2 | EXP7 | TE | CONTROL | Control Period | After completion of PRETEST Element | 30 days after start of Element | P30D | | 3 | EXP7 | TE | TREAT2 | 100 mg/kg Drug A, once daily | After completion of PRETEST Element | 30 days after start of Element | P30D | | 4 | EXP7 | TE | TREAT3 | 200 mg/kg Drug A, once daily | After completion of PRETEST Element | 30 days after start of Element | P30D | | 5 | EXP7 | TE | TREAT4 | 300 mg/kg Drug A, once daily | After completion of PRETEST Element | 30 days after start of Element | P30D | | 6 | EXP7 | TE | TREAT5 | 100 mg/kg Drug B, twice daily doses of 50 mg/kg each | After completion of PRETEST Element | 30 days after start of Element | P30D | | 7 | EXP7 | TE | TREAT6 | 200 mg/kg Drug B, twice daily doses of 100 mg/kg each | After completion of PRETEST Element | 30 days after start of Element | P30D | | 8 | EXP7 | TE | TREAT7 | 400 mg/kg Drug B, twice daily doses of 200 mg/kg each | After completion of PRETEST Element | 30 days after start of Element | P30D | | 9 | EXP7 | TE | RECOVERY | Recovery Period | After last dose with treatment product or vehicle control | 14 days after start of Element | P14D |
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