An example SDTM IS for vaccine studies
Format
A data frame with 24 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- ISSEQ
Sequence Number
- ISTESTCD
Immunogenicity Test/Exam Short Name
- ISTEST
Immunogenicity Test or Exam Name
- ISCAT
Category for Immunogenicity Test
- ISORRES
Result or Finding in Original Units
- ISORRESU
Original Units
- ISSTRESC
Character Result/Finding in Std Format
- ISSTRESN
Numeric Result/Finding in Standard Units
- ISSTRESU
Standard Units
- ISSTAT
Completion Status
- ISREASND
Reason Not Done
- ISNAM
Vendor Name
- ISSPEC
Specimen Type
- ISMETHOD
Method of Test or Examination
- ISBLFL
Baseline Flag
- ISLLOQ
Lower Limit of Quantitation
- VISITNUM
Visit Number
- EPOCH
Epoch
- ISDTC
Date/Time of Collection
- ISDY
Study Day of Collection
- ISULOQ
Upper Limit of Quantitation