Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

This example shows a CRF that collects electrocardiogram data utilizing a local reader. 

Excerpt


Image Added

Image Added

Expand
titleCDASH EC EG Metadata Specifications
Metadataspec
OrderQuestion TextPromptCRF Case Report Form Completion InstructionsTypeCDASH Collection VariableSDTMIG Target VariableSDTMIG Target MappingTabulation Target  Mapping Instructions  Controlled Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1Was the ECG performed?ECG PerformedIndicate whether or not an ECG or specific ECG test was done.TextEGPERFEGSTATEGSTAT
(NY)YesN; NoY
2What was the method used for the ECG?MethodRecord the method used for the ECG.TextEGMETHODEGMETHOD
(EGMETHOD)6 Lead Standard; 8 Lead Standard; 10 Lead Standard; 12 Lead Standard12 LEAD STANDARD;HOLTER CONTINUOUS ECG RECORDING
3What was the position of the subject during the ECG measurement?PositionRecord the position of the subject during the ECG.TextEGPOSEGPOS
(POSITION)Supine; SittingSITTING;STANDING;SUPINE;SEMI-RECUMBENT;SEMI-FOWLERS
4What was date of the ECG?ECG DateRecord the date ECG was done using this format. DateEGDTCEGDATEGDTC



5What was the Mean Heart Rate?ECG Mean Heart RateRecord the test result.IntegerEGHRMN_EGORRESEGORRESEGORRES where EGTESTCD ="EGHRMN"


6What was the unit of the Mean Heart Rate?UnitRecord or select the original unit in which these data were collected, if not pre-printed on CRF.TextEGHRMN_EGORRESUEGORRESEGORRESUEGORRESU where EGTESTCD = "EGHRMN"(Unit)beats/min
7What was the Aggregate PR Interval?PR Interval, AggregateRecord the test result.IntegerPRAG_EGORRESEGORRESEGORRES where EGTESTCD = "PRAG"


8What was the unit of the Aggregate PR Interval?UnitRecord or select the original unit in which these data were collected, if not pre-printed on CRF.TextPRAG_EGORRESUEGORRESEGORRESUEGORRESU where EGTESTCD = "PRAG"(Unit)msecs
9What was the Aggregate QRS Duration?QRS Duration, AggregateRecord the test result.IntegerQRSAG_EGORRESEGORRESEGORRES EGORRES where EGTESTCD = "QRSAG"


10What was the unit of the Aggregate QRS Duration?UnitRecord or select the original unit in which these data were collected, if not pre-printed on CRF.TextQRSAG_EGORRESUEGORRESEGORRESU EGORRESU where EGTESTCD = "QRSAG"(Unit)msecs
11What was the Aggregate QT Interval?QT Interval, AggregateRecord the test result.IntegerQTAG_EGORRESEGORRESEGORRES EGORRES where EGTESTCD = "QTAG"


12What was the unit of the Aggregate QT Interval result?UnitRecord or select the original unit in which these data were collected, if not pre-printed on CRF.TextQTAG_EGORRESUEGORRESEGORRESU EGORRESU where EGTESTCD = "QTAG"(Unit)msecs
13What was the Aggregate QTca Interval?QTca Interval, AggregateRecord the test result. IntegerQTCAAG_EGORRESEGORRESEGORRES EGORRES where EGTESTCD = "QTCA"


14What was the unit of the Aggregate QTca Interval?UnitRecord or select the original unit in which these data were collected, if not pre-printed on CRF.TextQTCAAG_EGORRESUEGORRESEGORRESU EGORRESU where EGTESTCD = "QTCA"(Unit)msecs
15What was the overall interpretation of the ECG?InterpretationRecord the the test result.TextINTP_EGORRESEGORRESEGORRES EGORRES where EGTESTCD = "INTP"(NORMABNM)NormalNORMAL; AbnormalABNORMAL
16Was the ECG clinically significant?Clinically SignificantRecord whether ECG results were clinically significant.TextEGCLSIGEGCLSIG
 (NY)Yes; No N:Y: