Versions Compared

Key

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

NEED TO GET THE CORRECT REFERNCES  More information can be found in  SDTMIG Section 4.4.7, Use of Relative Timing Variables. 

This is the SDTM dataset associated with the above example CRF. This SDTM dataset used CMENRF to represent ongoing interventions. More information can be found in SDTMIG  Section 42.48.7, Use of .6, Representing References and Relative Timing Variables. 

The sponsor include applicant included CMDECOD. The sponsor is applicant is required to provide the dictionary name and version in the Define-XML document. 

Dataset wrap
Namecm
Rowcaps
Rows 1-4:The subject  reported each instance of aspirin use. The frequency of each instance is represented in CMDOSFRQ and is ONCE. 
Rows 6-8: The subject reports the use of 3 medications. Diovan and Zoloft were still being taken by the subject, Astelin was a nasal spray where 2 sprays were taken twice a day in each nostril. Note that only partial start dates are provided for Diovan and Zoloft. 
Row 9:The subject took aspirin with a frequency of "PRN". This approach assumes that knowing exactly when aspirin was used is not important for evaluating safety and efficacy the product in this study.
Dataset2
RowSTUDYIDDOMAINUSUBJIDCMSEQCMTRTCMDECODCMINDCCMCLASCMDOSECMDOSTXTCMDOSUCMDOSFRMCMDOSFRQCMROUTECMSTDTCCMENDTCCMENRF
1ABC123CMABC123-00011ASPIRINacetylsalicylic acidMIGRAINEANALGESICS100
mgTABLETONCEORAL2006-10-
10
142006-10-
10
14
2ABC123CMABC123-00012ASPIRINacetylsalicylic acidMIGRAINEANALGESICS100
mgTABLETONCEORAL2006-10-
11
152006-
01
10-
11
15
3ABC123CMABC123-00013ASPIRINacetylsalicylic acidMIGRAINEANALGESICS100
mgTABLETONCEORAL2006-10-
12
162006-10-
12
16
4ABC123CMABC123-00014ASPIRINacetylsalicylic acidMIGRAINEANALGESICS100
mgTABLETONCEORAL2006-10-
13
172006-10-
13
17
5ABC123CMABC123-00015ASPIRINacetylsalicylic acidMIGRAINEANALGESICS100
mgTABLETONCEORAL2006-01-
14
182006-01-
14
18
6ABC123CMABC123-00021DIOVANvalsartanHYPERTENSIONANTIHYPERTENSIVES20
mgTABLETBIDORAL2004
AFTER
7ABC123CMABC123-00022ZOLOFTsertralinePANIC ATTACKSPSYCHOANALEPTICS50
mgTABLETODORAL2004-01
AFTER
8ABC123CMABC123-00023ASTELINazelastineINFLUENZANASAL PREPARATIONS
2 sprays in each nostril-137 mcgmcgSPRAYBIDNASAL
2004
2006-
01
02-
09
26
AFTER
2006-06-10
9ABC123CMABC123-0002
1
4ASPIRINacetylsalicylic acidPAINANALGESICS100
mgTABLETPRNORAL2004-01-01
AFTER