| Roworder | variable_name | variable_label | derivation |
|---|---|---|---|
| 001 | STUDYID | Study Identifier | Equals to the value from raw.demog.STUDY |
| 002 | DOMAIN | Domain Abbreviation | Assign as 'DM' |
| 003 | USUBJID | Unique Subject Identifier | Derive by concatenating raw.demog.STUDY and raw.demog.PT variable values, separated with a hyphen in between. |
| 004 | SUBJID | Subject Identifier for the Study | Equals to the value from raw.demog.PT |
| 005 | RFSTDTC | Subject Reference Start Date/Time | For the subjects with non-missing sdtm.dm.RFXSTDTC, Equals to the date component of sdtm.dm.RFXSTDTC. Else if a subject is randomized, then assign the value of raw.enrlment.RANDDT_RAW after converting to ISO 8601 format. Else assign the value of sdtm.dm.RFICDTC |
| 006 | RFENDTC | Subject Reference End Date/Time | Derive the date value in ISO 8601 format by obtaining the value from raw.eos.EOSTDT_RAW where raw.eos.EOSCAT="End of Study" |
| 007 | RFXSTDTC | Date/Time of First Study Treatment | Derive the datetime value in ISO 8601 format by obtaining the earliest non-missing raw.ipadmin.IPSTDT_RAW and raw.ipadmin.IPSTTM_RAW for each subject where raw.ipadmin.IPQTY_RAW is greater than 0. |
| 008 | RFXENDTC | Date/Time of Last Study Treatment | Derive the datetime value in ISO 8601 format by obtaining the latest non-missing raw.ipadmin.IPSTDT_RAW and raw.ipadmin.IPSTTM_RAW for each subject where raw.ipadmin.IPQTY_RAW is greater than 0. |
| 009 | RFICDTC | Date/Time of Informed Consent | Derive the date value in ISO 8601 format by obtaining the value from raw.enrlment.ICDT_RAW. |
| 010 | RFPENDTC | Date/Time of End of Participation | Derive the date value in ISO 8601 format by obtaining the latest date value from all raw datasets. Date variables in a dataset can be identified with the suffix of 'DT_RAW'. |
| 011 | DTHDTC | Date/Time of Death | Derive the date value in ISO 8601 format by obtaining the value from raw.eos.EOSDT_RAW where raw.eos.EOSCAT="End of Study" and raw.eos.EOSTERM="Death" |
| 012 | DTHFL | Subject Death Flag | Assign as "Y" on the records where sdtm.dm.DTHDTC is not null. |
| 013 | SITEID | Study Site Identifier | Equals to the first 2 characters from raw.demog.PT |
| 014 | AGE | Age | Equals to the value from raw.demog.AGE_RAW |
| 015 | AGEU | Age Units | Equals to the value from raw.demog.AGE_RAWU |
| 016 | SEX | Sex | Equals to the value from raw.demog.SEX after converting to standard controlled terminology. |
| 017 | RACE | Race | Derive sdtm.dm.RACE based on the values from raw.demog.RACE, raw.demog.RACE2, raw.demog.RACE3 and raw.demog.RACE4. If more than one of the above 4 variables is populated then assign a value of 'MULTIPLE', else assign the value from the populated variable after converting to standard controlled terminology. |
| 018 | ETHNIC | Ethnicity | Equals to the value from raw.demog.ETHNIC after converting to standard controlled terminology. |
| 019 | ARMCD | Planned Arm Code | Derive sdtm.dm.ARMCD based on the information present in raw.enrlment and raw.rand datasets. Part A) 1) Fetch the randomization number for each subject from raw.enrlment.RANDNO. 2) Fetch the raw.rand.TX_CD as ARMCD by joining the datasets based on RANDNO and raw.rand.RAND_ID. Part B) For the subjects with raw.enrlment.ICDT_RAW not null and raw.enrlment.ENRLDT_RAW is null, assign as 'SCRNFAIL'. Part C) For the subjects with raw.enrlment.ENRLDT_RAW not null and raw.enrlment.RANDDT_RAW is null, assign as 'NOTASSGN'. |
| 020 | ARM | Description of Planned Arm | Assign as 'Active' when sdtm.dm.ARMCD is equal to 'ACTIVE'. Else assign as 'Placebo' when sdtm.dm.ARMCD is equal to 'PBO'. Else assign as 'Screen Failure' when sdtm.dm.ARMCD="SCRNFAIL". Else assign as 'Not Assigned' when sdtm.dm.ARMCD="NOTASSGN" |
| 021 | ACTARMCD | Actual Arm Code | Derive sdtm.dm.ACTARMCD based on the information present in raw.ipadmin and raw.box datasets. Part A) 1) Fetch the raw.ipadmin.IPBOXID from the earliest record with non-missing IPQTY_RAW for each subject. 2) Fetch the raw.box.CONTENT as ACTARMCD by joining the datasets based on IPBOXID and raw.box.KITID. Part B) For subjects with sdtm.dm.ARMCD in ("SCRNFAIL" "NOTASSGN") assign the value of sdtm.dm.ARMCD. Part C) For the subjects with raw.rand.RANDDT_RAW not null and sdtm.dm.RFXSTDTC is null, assign as 'NOTTRT'. |
| 022 | ACTARM | Description of Actual Arm | Assign as 'Active' when sdtm.dm.ACTARMCD is equal to 'ACTIVE'. Else assign as 'Placebo' when sdtm.dm.ACTARMCD is equal to 'PBO'. Else assign as 'Screen Failure' when sdtm.dm.ACTARMCD="SCRNFAIL". Else assign as 'Not Assigned' when sdtm.dm.ACTARMCD="NOTASSGN". Else assign as 'Not Treated' when sdtm.dm.ACTARMCD="NOTTRT". |
| 023 | COUNTRY | Country | Equals to the value from raw.demog.COUNTRY |
| 024 | RACE1 | Race 1 | Equals to the value from raw.demog.RACE when sdtm.dm.RACE is 'MULTIPLE' after converting to standard controlled terminology. |
| 025 | RACE2 | Race 2 | Equals to the value from raw.demog.RACE2 when sdtm.dm.RACE is 'MULTIPLE' after converting to standard controlled terminology. |
| 026 | RACE3 | Race 3 | Equals to the value from raw.demog.RACE3 when sdtm.dm.RACE is 'MULTIPLE' after converting to standard controlled terminology. |
| 027 | RACE4 | Race 4 | Equals to the value from raw.demog.RACE4 when sdtm.dm.RACE is 'MULTIPLE' after converting to standard controlled terminology. |
| 028 | RACESP | Race Other Specify | Equals to the value form raw.demog.RACESP. |