myCSG © |Area: SDTM| Concept: DS : Disposition | Lesson: LCSG001 : Disposition dataset programming |
Disposition Events and Protocol Milestones
Lesson description will be added soon
Lesson description will be added soon
| variable_name | variable_label | derivation |
|---|---|---|
| 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.ds |
| DOMAIN | Domain Abbreviation | Assign as "DS" |
| USUBJID | Unique Subject Identifier | Derive by concatenating raw.xxx.STUDY and raw.xxx.PT variable values, separated with a hyphen in between. 'xxx' corresponds to the raw dataset from which a row is created in sdtm.ds |
| DSSEQ | Sequence Number | Sort the dataset by USUBJID, DSSTDTC and assign 1 on the first record for each subject, and increment by 1 on each subsequent record for subject. |
| DSREFID | Reference ID | Equals to the value from raw.enrlment.RANDNO, only on the record where sdtm.ds.DSDECOD="RANDOMIZED". |
| DSTERM | Reported Term for the Disposition Event | See DSSTDTC variable derivation for details. Part A) Protocol Milestones 1) Informed consent: Assign as "INFORMED CONSENT OBTAINED" 2) Enrolled: Assign as "ENROLLED TO STUDY" 3) Randomization: Assign as "RANDOMIZED" Part B) Disposition Events 1) End of investigation product: Equals to the value from raw.eoip.EOTERM 2) End of study: Equals to the value from raw.eos.EOTERM |
| DSDECOD | Standardized Disposition Term | See DSSTDTC variable derivation for details. Part A) Protocol Milestones 1) Informed consent: Assign as "INFORMED CONSENT OBTAINED" 2) Enrolled: Assign as "ELIGIBILITY CRITERIA MET" 3) Randomization: Assign as "RANDOMIZED" Part B) Disposition Events 1) End of investigation product: Equals to the value from raw.eoip.EOTERM after converting to standard controlled terminology 2) End of study: Equals to the value from raw.eos.EOTERM after converting to standard controlled terminology |
| DSCAT | Category for Disposition Event | Assign as "PROTOCOL MILESTONE" for the protocol milestone records, and assign as "DISPOSITION EVENT" for the disposition event related records |
| DSSCAT | Subcategory for Disposition Event | Assign as 'END OF SUDY' for the disposition event record created from raw.eos. Assign as 'END OF INVESTIGATIONAL PRODUCT' for the disposition event record created from raw.eoip. |
| DSSTDTC | Start Date/Time of Disposition Event | Create a record only when the corresponding input raw date variable value is not null. Part A) Protocol Milestones 1) Informed consent: Equals to the value from raw.enrlment.ICDT_RAW after converting to ISO 8601 format. 2) Enrolled: Equals to the value from raw.enrlment.ENRLDT_RAW after converting to ISO 8601 format. 3) Randomization: Equals to the value from raw.enrlment.RANDDT_RAW after converting to ISO 8601 format. Part B) Disposition Events 1) End of investigation product: Equals to the value from raw.eoip.EOSTDT_RAW after converting to ISO 8601 format. 2) End of study: Equals to the value from raw.eos.EOSSTDT_RAW after converting to ISO 8601 format |
| DSSTDY | Study Day of Start of Disposition Event | 1) Fetch sdtm.DM.RFSTDTC for each subject and create a temporary variable named RFSTDT by extracting the date portion and converting it to numeric value. 2) Extract the date portion from sdtm.ds.DSSTDTC and create a temporary variable named DSSTDT by converting it to numeric value. 3)Derive DSSTDY only when both DSSTDT and RFSTDT are not null. If DSSTDT>=RFSTDT then DSSTDY=(DSSTDT-RFSTDT)+1. Else if DSSTDT |
| PROTVERS | Enrolled Protocol Version | Equals to the value from raw.enrlment.PRTVERS, only on the record where sdtm.ds.DSDECOD="INFORMED CONSENT OBTAINED". |
| CNSTVERS | Enrolled Consent Version | Equals to the value from raw.enrlment.ICVERS, only on the record where sdtm.ds.DSDECOD="INFORMED CONSENT OBTAINED". |
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