A SDTM RS dataset using iRECIST intended for examples of ADaM dataset creation
Format
A data frame with 19 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- RSSEQ
Sequence Number
- RSLNKGRP
Link Group ID
- RSTESTCD
Assessment Short Name
- RSTEST
Assessment Name
- RSCAT
Category for Assessment
- RSORRES
Result or Finding in Original Units
- RSSTRESC
Character Result/Finding in Std Format
- RSSTAT
Completion Status
- RSREASND
Reason Not Done
- RSEVAL
Evaluator
- RSEVALID
Evaluator Identifier
- RSACPTFL
Accepted Record Flag
- VISITNUM
Visit Number
- VISIT
Visit Name
- RSDTC
Date/Time of Assessment
- RSDY
Study Day of Assessment
Details
Disease Response (iRECIST) for Oncology
A SDTM RS dataset using iRECIST intended for examples of ADaM dataset creation
Contains a set of 6 unique Test Short Names and Test Names:
| RSTESTCD | RSTEST |
| IRECLIND | Last iRECIST Assessment Indicator |
| NEWLIND | New Lesion Indicator |
| NEWLPROG | New Lesion Progression |
| NTRGRESP | Non-target Response |
| OVRLRESP | Overall Response |
| TRGRESP | Target Response |