Example of Simple Parallel Design, No Recovery |
This example assumes a simple parallel design in which the applicant-defined protocol specifies the following information. All subjects are to be screened for 7 days prior to randomization into 3 protocol groups:
- Group 1 is a control group of 20 subjects, 10 male and 10 female, dosed with vehicle once per day for 28 days.
- Group 2 is a low-dose group of 20 subjects, 10 male and 10 female, dosed at 100 mg/kg once per day for 28 days.
- Group 3 is a high-dose group of 20 subjects, 10 male and 10 female, dosed at 500 mg/kg once per day for 28 days.
There are no other experimental factors of interest specified in the study design. There are only 3 trial sets in this scenario, because there are no nontreatment factors to consider. In this example, the applicant has chosen to provide a small amount of additional information about each trial set, including the associated arm code, applicant-defined protocol group number, control group type, group label, and dose level and units, and the applicant has made the assumption that male and female animals will be compared separately when relevant.
| Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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| 1 | EXP1 | TX | 1 | Control Group, Vehicle Control once daily | 1 | ARMCD | Arm Code | 1 | | 2 | EXP1 | TX | 1 | Control Group, Vehicle Control once daily | 2 | SPGRPCD | Applicant-Defined Group Code | 1 | | 3 | EXP1 | TX | 1 | Control Group, Vehicle Control once daily | 3 | TCNTRL | Control Type | VEHICLE CONTROL | | 4 | EXP1 | TX | 1 | Control Group, Vehicle Control once daily | 4 | GRPLBL | Group Label | Group 1, Control | | 5 | EXP1 | TX | 1 | Control Group, Vehicle Control once daily | 5 | TRTDOS | Dose Level | 0 | | 6 | EXP1 | TX | 1 | Control Group, Vehicle Control once daily | 6 | TRTDOSU | Dose Units | mg/kg/day | | 7 | EXP1 | TX | 2 | Low-Dose Group, 100 mg/kg Drug a once daily | 7 | ARMCD | Arm Code | 2 | | 8 | EXP1 | TX | 2 | Low-Dose Group, 100 mg/kg Drug a once daily | 8 | SPGRPCD | Applicant-Defined Group Code | 2 | | 9 | EXP1 | TX | 2 | Low-Dose Group, 100 mg/kg Drug a once daily | 9 | GRPLBL | Group Label | Group 2, 100 mg/kg/day | | 10 | EXP1 | TX | 2 | Low-Dose Group, 100 mg/kg Drug a once daily | 10 | TRTDOS | Dose Level | 100 | | 11 | EXP1 | TX | 2 | Low-Dose Group, 100 mg/kg Drug a once daily | 11 | TRTDOSU | Dose Units | mg/kg/day | | 12 | EXP1 | TX | 3 | High-Dose Group, 500 mg/kg Drug a once daily | 12 | ARMCD | Arm Code | 3 | | 13 | EXP1 | TX | 3 | High-Dose Group, 500 mg/kg Drug a once daily | 13 | SPGRPCD | Applicant-Defined Group Code | 3 | | 14 | EXP1 | TX | 3 | High-Dose Group, 500 mg/kg Drug a once daily | 14 | GRPLBL | Group Label | Group 3, 500 mg/kg/day | | 15 | EXP1 | TX | 3 | High-Dose Group, 500 mg/kg Drug a once daily | 15 | TRTDOS | Dose Level | 500 | | 16 | EXP1 | TX | 3 | High-Dose Group, 500 mg/kg Drug a once daily | 16 | TRTDOSU | Dose Units | mg/kg/day |
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