An example SDTM CE dataset for vaccine studies
Format
A data frame with 29 columns:
- STUDYID
Study Identifier
- DOMAIN
Domain Abbreviation
- USUBJID
Unique Subject Identifier
- CESEQ
Sequence Number
- CELNKID
Link ID
- CELNKGRP
Link Group ID
- CETERM
Reported Term for the Clinical Event
- CEDECOD
Dictionary-Derived Term
- CELAT
Laterality of Location of Clinical Event
- CELOC
Location of Clinical Event
- CECAT
Category for Clinical Event
- CESCAT
Subcategory for Clinical Event
- CEPRESP
Clinical Event Pre-Specified
- CEOCCUR
Clinical Event Occurrence
- CESEV
Severity/Intensity
- CEREL
Causality
- CEOUT
Outcome of Clinical Event
- EPOCH
Epoch
- CEDTC
Date/Time of Event Collection
- CESTDTC
Start Date/Time of Clinical Event
- CEENDTC
End Date/Time of Clinical Event
- CEDUR
Duration of Clinical Event
- CETPT
Planned Time Point Name
- CETPTNUM
Planned Time Point Number
- CETPTREF
Time Point Reference
- CERFTDTC
Date/Time of Reference Time Point
- CEEVINTX
Evaluation Interval Text
- CESTAT
Completion Status
- CEREASND
Reason Clinical Event Not Collected