The field guide

Selected variable lessons

Model 2.0IG 3.4Content 1.0.0Curated educational coverage

AE · Adverse Events

  • STUDYIDLocate the study behind AE
  • DOMAINIdentify the AE representation
  • USUBJIDJoin AE observations to a subject
  • AESEQDistinguish AE records
  • AETERMKeep the reported event wording
  • AESTDTCPreserve the known start precision
  • AEENDTCAn end date can remain unknown
  • AESERKeep seriousness distinct from severity

CM · Concomitant Medications

  • STUDYIDLocate the study behind CM
  • DOMAINIdentify the CM representation
  • USUBJIDJoin CM observations to a subject
  • CMSEQDistinguish CM records
  • CMTRTRetain the treatment as reported
  • CMSTDTCA treatment start with known precision
  • CMENDTCA treatment end without an invented date

DM · Demographics

  • STUDYIDLocate the study behind DM
  • DOMAINIdentify the DM representation
  • USUBJIDJoin DM observations to a subject
  • SUBJIDThe study-local subject label
  • AGEA recorded age example
  • SEXA categorical field with an external vocabulary
  • RFSTDTCA reference date, not a universal start

EX · Exposure

  • STUDYIDLocate the study behind EX
  • DOMAINIdentify the EX representation
  • USUBJIDJoin EX observations to a subject
  • EXSEQDistinguish EX records
  • EXTRTIdentify the treatment being represented
  • EXDOSERead a number with its missing context

LB · Laboratory Tests

  • STUDYIDLocate the study behind LB
  • DOMAINIdentify the LB representation
  • USUBJIDJoin LB observations to a subject
  • LBSEQDistinguish LB records
  • LBTESTCDIdentify which finding a row represents
  • LBORRESPreserve the original result text
  • LBORRESUKeep the reported unit nearby
  • LBDTCAssociate time with the observation

VS · Vital Signs

  • STUDYIDLocate the study behind VS
  • DOMAINIdentify the VS representation
  • USUBJIDJoin VS observations to a subject
  • VSSEQDistinguish VS records
  • VSTESTCDDistinguish repeated measurements
  • VSORRESKeep the collected representation
  • VSORRESUCarry units with the value
  • VSDTCKeep collection timing distinct