myCSG © |Area: SDTM| Concept: SE : Subject Elements | Lesson: LCSG001 : Subject Elements programming |
Lesson description will be added soon
| variable_name | variable_label | derivation |
|---|---|---|
| STUDYID | Study Identifier | Equals to the value from sdtm.dm.STUDYID |
| DOMAIN | Domain Abbreviation | Assign as 'SE' |
| USUBJID | Unique Subject Identifier | Equals to the value from sdtm.dm.USUBJID |
| SESEQ | Sequence Number | Sort the records by USUBJID, TAETORD and assign as 1 on the first record of each subject and increment by 1 for each subsequent record for that subject. |
| ETCD | Element Code | See the derivation details in SESTDTC. 1) Equals to "SCR" on the screening record. 2) Equals to "ACTIVE" on the record corresponding to treatment element of subjects assigned to "ACTIVE" arm. 3) Equals to "PBO" on the record corresponding to treatment element of subejcts assigned to "PBO" arm. 4) Equals to "FUP" on the record corresponding to "Follow-up" element. |
| ELEMENT | Description of Element | 1) Equals to "Screening" when sdtm.se.ETCD="SCR". 2) Equals to "Active" when sdtm.se.ETCD="ACTIVE". 3) Equals to "Placebo" when sdtm.se.ETCD="PBO". 4) Equals to "Follow-up" when sdtm.se.ETCD="FUP". |
| TAETORD | Planned Order of Element within Arm | 1) Equals to 1 when sdtm.se.ETCD="SCR". 2) Equals to 2 when sdtm.se.ETCD="ACTIVE". 3) Equals to 2 when sdtm.se.ETCD="PBO". 4) Equals to 3 when sdtm.se.ETCD="FUP". |
| EPOCH | Epoch | 1) Equals to "SCREENING" when sdtm.se.ETCD="SCR". 2) Equals to "TREATMENT" when sdtm.se.ETCD in ("PBO" "ACTIVE"). 3) Equals to "FOLLOW-UP" when sdtm.se.ETCD="FUP". |
| SESTDTC | Start Date/Time of Element | A) Screening: Equals to the value from sdtm.dm.RFICDTC B) Active: For the subjects with sdtm.dm.ARMCD="ACTIVE", equals to the value from sdtm.dm.RFXSTDTC C) Placebo: For the subjects with sdtm.dm.ARMCD="PBO", equals to the value from sdtm.dm.RFXSTDTC D) Follow-up: a) For the subjects who entered into follow-up period(a record with non-missing sdtm.sv.SVSTDTC and sdtm.sv.VISIT contains "FOLLOW-UP"), Equals to the value from raw.eoip.EOSTDT_RAW after converting into ISO 8601 format. |
| SEENDTC | End Date/Time of Element | A) Screening: 1) For the subjects with non-missing sdtm.dm.RFXSTDTC value, equals to the value from sdtm.dm.RFXSTDTC. 2) For the subjects with missing sdtm.dm.RFXSTDTC value, equals to the value from sdtm.dm.RFPENDTC B and C) For both Active and Placebo elements: a) For the subjects who entered follow-up, Equals to the value from raw.eoip.EOSTDT_RAW after converting into ISO 8601 format. b) For the subjects who did not enter follow-up and, 1) has a end of study record, populate with the value raw.eos.EOSTDT_RAW where raw.eos.EOSCAT="End of Study". 2) has no end of study record, populate with the latest value from sdtm.sv.SVENDTC of that subject. C) Follow-up: 1) For the subjects with non-missing sdtm.se.SESTDTC for follow-up element and , a) has a end of study record, populate with the value raw.eos.EOSTDT_RAW where raw.eos.EOSCAT="End of Study". b) has no end of study record, populate with the latest value from sdtm.sv.SVENDTC of that subject. |
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