myCSG © |Area: SDTM| Concept: SV : Subject Visits | Lesson: LCSG001 : Subject Visits programming |
Appending all datasets with visit information
Fetching earliest date of a visit as SVSTDTC
Fetching latest date of a visit as SVENDTC
Lesson description will be added soon
Fetching earliest date of a visit as SVSTDTC
Fetching latest date of a visit as SVENDTC
Lesson description will be added soon
| variable_name | variable_label | derivation |
|---|---|---|
| General | SV domain is a derived dataset. Generally it is derived by pooling all datasets where visit level information is collected. The earliest date of a visit within a subject across all datasets is mapped to SVSTDTC and the latest date of a visit within a subject across all datasets is mapped to SVENDTC. Unsheduled visits are remapped such that the numeric version of visit value (VISITNUM) is incremented by a decimal portion from the previous scheduled visit's VISITNUM. Similarly, character version of visit (VISIT) is concatenated with the text 'UNSCHEDULED' and the number of unscheduled visit number to the previous scheduled visit's value. |
|
| STUDYID | Study Identifier | Equals to the value from raw.xxx.STUDY, where xxx corresponds to the raw dataset from which a row is created in sdtm.sv |
| DOMAIN | Domain Abbreviation | Assign as 'SV' |
| USUBJID | Unique Subject Identifier | Derive by concatenating raw.xxx.STUDY and raw.xxx.PT variable values, separated with a hyphen in between, where xxx corresponds to the raw dataset from which a row is created in sdtm.sv |
| VISITNUM | Visit Number | Derive by using raw.xxx.FOLDER variable. For scheduled visits (raw.xxx.FOLDER does not contain "UNSCHEDULED"): Equals to 1 when raw.xxx.FOLDER='SCREENING', Equals to 100+the digit from raw.xxx.FOLDER variable when raw.xxx.FOLDER contains "WEEK", Equals to 200+the digit from raw.xxx.FOLDER when raw.xxx.FOLDER starts with "FU". For unscheduled visits (raw.xxx.FOLDER contains "UNSCHEDULED"): Equals to the visitnum of the previous scheduled plus 0.01 for each unscheduled visit after the previous scheduled visit |
| VISIT | Visit Name | Derive by using raw.xxx.FOLDER variable. For scheduled visits (raw.xxx.FOLDER does not contain "UNSCHEDULED"): Equals to the upper case values from FOLDER variable. For unscheduled visits (raw.xxx.FOLDER contains "UNSCHEDULED"): Equals to the VISIT of the previous scheduled sdtm.sv.VISIT concatenated with the 0 padded integer corresponding to the number of unscheduled visit after the previous scheduled visit. |
| SVSTDTC | Start Date/Time of Visit | Derive SVSTDTC as described in General notes |
| SVENDTC | End Date/Time of Visit | Derive SVENDTC as described in General notes |
| SVSTDY | Study Day of Start of Visit | If the visit start date is on or after reference start date then sdtm.sv.SVSTDTC-sdtm.dm.RFSTDTC +1. Else if date is before reference start date then assign as sdtm.sv.SVSTDTC-sdtm.dm.RFSTDTC. |
| SVENDY | Study Day of End of Visit | If the visit end date is on or after reference start date then sdtm.sv.SVENDTC-sdtm.dm.RFSTDTC +1. Else if date is before reference start date then assign as sdtm.sv.SVENDTC-sdtm.dm.RFSTDTC. |
| SVUPDES | Description of Unplanned Visit | For each unscheduled visit, concatenate the sdtm domains separated by comma in which the respective unscheduled visit is part of. |
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