Validation Checks

The following table provides a complete list of CDISC SDTM validation checks. WebSDM V3.0 changed the IR numbers for 3.1.2, and all begin with 5000. These numbers are listed in parentheses.
Validation Checks
checkid
check
source
sourceid*
source
description
table
scope
column
scope
3.1.1
3.1.2
SDTM0001
Janus
IR4000
(IR5000)
Identifies domain table that has zero rows and, therefore, contains no data.
_ALL_
X
SDTM0001
WebSDM
IR4000
(IR5000)
Identifies domain table that has zero rows and, therefore, contains no data.
_ALL_
X
X
SDTM0002
JanusFR
SAS0017
A load of data into Janus requires that the DM, DS, and EX domains be submitted for each study to be loaded.
DM+DS+EX
X
SDTM0002
SAS
SAS0017
A load of data into JANUS requires that the DM, DS, and EX domains be submitted for each study to be loaded.
DM+DS+EX
X
SDTM0003
WebSDM
SAS0018
WebSDM and the SDTM model require only the DM domain be present.
DM
X
X
SDTM0004
SAS
SAS0033
Source metadata includes domain data set not found in reference metadata.
_ALL_
X
X
SDTM0005
SAS
SAS0034
Custom domain data set does not conform to specification naming guidelines.
_ALL_
X
X
SDTM0006
SAS
SAS0035
Source data library contains domain data not found in study metadata.
_ALL_
X
X
SDTM0011
Janus
IR4250
Identifies a column that was described in the domain description, but not included in the SAS data set for that domain.
_ALL_
X
SDTM0011
WebSDM
IR4250
(IR5250)
Identifies a column that was described in the domain description, but not included in the SAS data set for that domain.
_ALL_
X
X
SDTM0012
JanusFR
IR4252
Identifies a column listed in the domain description as required (Req), but not included in the SAS data set for that domain.
_ALL_
X
SDTM0012
WebSDM
IR4252
(IR5252)
Identifies a column listed in the domain description as required (Req), but not included in the SAS data set for that domain.
_ALL_
X
X
SDTM0013
Janus
IR4253
Identifies a column listed in the domain description as expected (Exp), but not included in the SAS data set for that domain.
_ALL_
X
SDTM0013
WebSDM
IR4253
(IR5253)
Identifies a column listed in the domain description as expected (Exp), but not included in the SAS data set for that domain.
_ALL_
X
X
SDTM0014
SAS
SAS0008
Identifies a column listed in the domain description as permissible (Perm), but not included in the SAS data set for that domain.
_ALL_
X
X
SDTM0015
Janus
IR4254
Identifies a column that appears in the SAS data set, but is not listed in the domain description.
_ALL_
X
SDTM0015
WebSDM
IR4254
(IR5254)
Identifies a column that appears in the SAS data set, but is not listed in the domain description.
_ALL_
X
X
SDTM0016
WebSDM
IR5260
Identifies a variable that is present in the SAS data set, but not present in the (study-specific) description file.
_ALL_
X
SDTM0017
Janus
IR4258
Identifies a domain that appears to contain supplemental qualifier data, but does not contain the unique subject identifier (USUBJID).
SUPP**
X
SDTM0017
WebSDM
IR4258
(IR5258)
Identifies a domain that appears to contain supplemental qualifier data, but does not contain the unique subject identifier (USUBJID).
SUPP**
X
X
SDTM0019
JanusFR
IR4259
Identifies a variable where data type in (study-specific) description is not consistent with data type implicit in SAS data set.
_ALL_
X
SDTM0019
WebSDM
IR4259
(IR5259)
Identifies a variable where data type in (study-specific) description is not consistent with data type implicit in SAS data set.
_ALL_
X
X
SDTM0020
SAS
SAS0006
Column order does not match standard.
_ALL_
X
X
SDTM0022
SAS
SAS0001
Column length < length defined in standard.
_ALL_
X
X
SDTM0023
SAS
SAS0002
Column length > length defined in standard.
_ALL_
X
X
SDTM0030
WebSDM
IR4264
(IR5264)
Column label inconsistent with label defined in standard.
_ALL_
X
X
SDTM0031
SAS
SAS0004
Column format found, but column not subject to controlled terminology.
_ALL_
X
X
SDTM0032
SAS
SAS0005
Column format found, but format name mismatch with standard controlled terminology name.
_ALL_
X
X
SDTM0033
WebSDM
IR4266
(IR5266)
Identifies a variable that has been deprecated according to the CDISC SDTM standard.
_ALL_
X
X
SDTM034
WebSDM
IR5251
Identifies a column where the expected data type that is inferred from the description file does not match the data type in the data set.
_ALL_
X
SDTM035
WebSDM
IR5261
Identifies a domain that is referenced in a description file, but for which there is no source data.
_ALL_
X
SDTM036
WebSDM
IR5262
Identifies a domain whose source data failed to load.
_ALL_
X
SDTM037
WebSDM
IR5263
Identifies a variable that uses an unsupported event dictionary.
_ALL_
X
SDTM038
WebSDM
IR5265
Identifies a variable whose referenced codelist is not properly defined in the associated define.xml file.
_ALL_
X
SDTM039
WebSDM
IR5267
Identifies a domain for which metadata has not been provided.
_ALL_
X
SDTM0101
JanusFR
IR4002
Identifies values that do not conform to the ISO 8601 standard for datetimes.
_ALL_
**DTC+**STDTC+**ENDTC+BRTHDTC+RFSTDTC+RFENDTC
X
SDTM0101
WebSDM
IR4002
(IR5002)
Identifies values that do not conform to the ISO 8601 standard for datetimes.
_ALL_
**DTC+**STDTC+**ENDTC+BRTHDTC+RFSTDTC+RFENDTC
X
X
SDTM0102
JanusFR
IR4002
Identifies values that do not conform to the ISO 8601 standard for durations.
_ALL_
**DUR
X
SDTM0102
WebSDM
IR4002
(IR5002)
Identifies values that do not conform to the ISO 8601 standard for durations.
_ALL_
**DUR
X
X
SDTM0124
Janus
IR4113
Identifies records that violate the condition [LENGTH(Name of Measurement, Test, or Examination (**TEST)) less than or equal to 40 characters].
CLASS:FINDINGS
**TEST
X
SDTM0124
WebSDM
IR4113
(IR5113)
Identifies records that violate the condition [LENGTH(Name of Measurement, Test, or Examination (**TEST)) less than or equal to 40 characters].
CLASS:FINDINGS
**TEST
X
X
SDTM0125
Janus
IR4114
Identifies records that violate the condition [LENGTH(Sort Name of Measurement, Test, or Examination (**TESTCD)) less than or equal to 8 characters, cannot start with a number, or contain special characters].
CLASS:FINDINGS
**TESTCD
X
SDTM0125
WebSDM
IR4114
(IR5114)
Identifies records that violate the condition [LENGTH(Sort Name of Measurement, Test, or Examination (**TESTCD)) less than or equal to 8 characters, cannot start with a number, or contain special characters].
CLASS:FINDINGS
**TESTCD
X
X
SDTM0126
SAS
SAS0017
Qualifier variable label (QLABEL) length > 40.
SUPP**
QLABEL
X
X
SDTM0127
SAS
SAS0018
Qualifier variable name (QNAM) length > 8, starts with a number, or contains special characters.
SUPP**
QNAM
X
X
SDTM0128
Janus
IR4115
Identifies records that violate the condition [LENGTH(Trial Summary Parameter (**PARM)) less than or equal to 40 characters].
TS
TSPARM
X
SDTM0128
WebSDM
IR4115
(IR5115)
Identifies records that violate the condition [LENGTH(Trial Summary Parameter (**PARM)) less than or equal to 40 characters].
TS
TSPARM
X
X
SDTM0129
Janus
IR4116
Identifies records that violate the condition [LENGTH(Trial Summary Parameter Sort Name (**PARMCD)) less than or equal to 8 characters, cannot start with a number, or contain special characters].
TS
TSPARMCD
X
SDTM0129
WebSDM
IR4116
(IR5116)
Identifies records that violate the condition [LENGTH(Trial Summary Parameter Sort Name (**PARMCD)) less than or equal to 8 characters, cannot start with a number, or contain special characters].
TS
TSPARMCD
X
X
SDTM0130
OpenCDISC
SD1004
The value of planned arm code (ARMCD) must not be more than 20 characters in length.
X
SDTM0131
OpenCDISC
SD1009
The value of the element code (ETCD) must not be no more than 8 characters in length.
X
SDTM0190
WebSDM
IR5517
Identifies subjects with records that violate the condition [(Start date/time of adverse event less than or equal to start date/time of collection less than or equal to start date/time of disposition event) or (latest exposure date less than or equal to start date/time of disposition event)], limited to records where the cited variables are not null.
DS+AE+EG+LB+VS+EX
X
SDTM0191
OpenCDISC
SD0080
Start date/time of adverse event (AESTDTC) must be less than or equal to the start date/time of the latest disposition event (DSSTDTC).
AE
[AESTDTC]
[DSSTDTC]
X
SDTM0192
OpenCDISC
SD0081
Date/time of collection (DTC) must be less than or equal to the start date/time of the latest disposition event (DSSTDTC).
EG+LB+VS
[**DTC]
[DSSTDTC]
X
SDTM0193
OpenCDISC
SD0082
End of date/time of treatment (EXENDTC) must be less than or equal to the start date/time of the latest disposition event (DSSTDTC).
EX
[EXENDTC]
[DSSTDTC]
X
SDTM0201
Janus
IR4001
Identifies a null (empty) value found in a column where (Standard) Core attribute is Req.
_ALL_
X
SDTM0201
WebSDM
IR4001
(IR5001)
Identifies a null (empty) value found in a column where (Standard) Core attribute is Req.
_ALL_
X
X
SDTM0202
SAS
SAS0015
Identifies a null (empty) value found in a column where (Standard) Core attribute is Exp.
_ALL_
X
X
SDTM0203
SAS
SAS0010
Character column value is not correctly uppercased per specification.
_ALL_
X
X
SDTM0204
SAS
SAS0011
Character column value contains the numeric missing '.' or any special missing value like '.N'.
_ALL_
X
X
SDTM0205
SAS
SAS0012
Column value is not left-justified.
_ALL_
X
X
SDTM0206
Janus
IR4003
Identifies records where the value in the Domain Abbreviation column (DOMAIN) does not match the name of Domain.
_ALL_-SUPP**-RELREC
DOMAIN
X
SDTM0206
WebSDM
IR4003
(IR5003)
Identifies records where the value in the Domain Abbreviation column (DOMAIN) does not match the name of Domain.
_ALL_-SUPP**-RELREC
DOMAIN
X
X
SDTM0207
Janus
IR4010
Identifies records where the value for Visit Number (VISITNUM) is formatted to more than three decimal places.
_ALL_
VISITNUM
X
SDTM0207
WebSDM
IR4010
(IR5010)
Identifies records where the value for Visit Number (VISITNUM) is formatted to more than 3 decimal places.
_ALL_
VISITNUM
X
X
SDTM0208
Janus
IR4009
Identifies records where Result or Finding in Original Units (**ORRES) and Status (**STAT) both have a value, or where both are null and Derived Flag (**DRVFL) is not equal to 'Y'.
CLASS:FINDINGS-IE
[**ORRES][**STAT]
X
SDTM0208
WebSDM
IR4009
Identifies records where Result or Finding in Original Units (**ORRES) and Status (**STAT) both have a value, or where both are null and Derived Flag (**DRVFL) is not equal to 'Y'.
CLASS:FINDINGS-IE
[**ORRES][**STAT]
X
SDTM0209
JanusFR
IR4100
Identifies records that violate the condition [Study Day of Start of Observation (**STDY) less than or equal to Study Day of End of Observation (**ENDY)], limited to records where **STDY is not null and **ENDY is not null.
_ALL_-DS
[**STDY][**ENDY]
X
SDTM0209
WebSDM
IR4100
(IR5100)
Identifies records that violate the condition [Study Day of Start of Observation (**STDY) less than or equal to Study Day of End of Observation (**ENDY)], limited to records where **STDY is not null and **ENDY is not null.
_ALL_-DS
[**STDY][**ENDY]
X
X
SDTM0210
JanusFR
IR4101
Identifies records that violate the condition [Start Date/Time of Observation (**STDTC) less than or equal to End Date/Time of Observation (**ENDTC)], limited to records where **STDTC is not null and **ENDTC is not null.
_ALL_-DS-LB
[**STDTC][**ENDTC]
X
SDTM0210
WebSDM
IR5101
Identifies records that violate the condition [Start Date/Time of Observation (**STDTC) less than or equal to End Date/Time of Observation (**ENDTC)], limited to records where **STDTC is not null and **ENDTC is not null.
_ALL_-DS-LB-PC-SV
[**STDTC]
[**ENDTC]
X
SDTM0210
WebSDM
IR4101
Identifies records that violate the condition [Start Date/Time of Observation (**STDTC) less than or equal to End Date/Time of Observation (**ENDTC)], limited to records where **STDTC is not null and **ENDTC is not null.
_ALL_-DS-LB
[**STDTC][**ENDTC]
X
SDTM0211
Janus
IR4130
Identifies records that violate the condition [Start Date/Time of Observation (**STDTC) or Start Relative to Reference Period (**STRF) is not null], limited to records where [End Date/Time of Observation (**ENDTC) or End Relative to Reference Period (**ENRF) is not null].
CM+SU
[**STRF][**ENRF]
X
SDTM0211
Janus
IR4130
Identifies records that violate the condition [Start Date/Time of Observation (**STDTC) or Start Relative to Reference Period (**STRF) is not null], limited to records where [End Date/Time of Observation (**ENDTC) or End Relative to Reference Period (**ENRF) is not null].
_ALL_-DS-LB
[**STDTC][**ENDTC]
X
SDTM0211
WebSDM
IR4130
Identifies records that violate the condition [Start Date/Time of Observation (**STDTC) or Start Relative to Reference Period (**STRF) is not null], limited to records where [End Date/Time of Observation (**ENDTC) or End Relative to Reference Period (**ENRF) is not null].
CM+SU
[**STRF][**ENRF]
X
SDTM0211
WebSDM
IR5130
Identifies records that violate the condition [start date/time of observation (**STDTC) or start relative to reference period (**STRF) is not null], limited to records where [end date/time of observation (**ENDTC) or end relative to reference period (**ENDRF) is not null].
CE+CM+SU
[**STRTF]
[**ENRF]
X
SDTM0211
WebSDM
IR4130
Identifies records that violate the condition [Start Date/Time of Observation (**STDTC) or Start Relative to Reference Period (**STRF) is not null], limited to records where [End Date/Time of Observation (**ENDTC) or End Relative to Reference Period (**ENRF) is not null].
_ALL_-DS-LB
[**STDTC][**ENDTC]
X
SDTM0211
WebSDM
IR5130
Identifies records that violate the condition [start date/time of observation (**STDTC) or start relative to reference period (**STRF) is not null], limited to records where [end date/time of observation (**ENDTC) or end relative to reference period (**ENDRF) is not null].
_ALL_-DS-LB-PC-SV
[**STDTC]
[**ENDTC]
X
SDTM0212
Janus
IR4131
Identifies records that violate the condition [Planned Time Point Name (**TPT) is not null], limited to records where [Planned Time Point Number (**TPTNUM) is not null].
_ALL_
[**TPT][**TPTNUM]
X
SDTM0212
WebSDM
IR4131
(IR5131)
Identifies records that violate the condition [Planned Time Point Name (**TPT) is not null], limited to records where [Planned Time Point Number (**TPTNUM) is not null].
_ALL_
[**TPT][**TPTNUM]
X
X
SDTM0213
Janus
IR4132
Identifies records that violate the condition [Planned Time Point Number (**TPTNUM) is not null], limited to records where [Planned Time Point Name (**TPT) is not null].
_ALL_
[**TPT][**TPTNUM]
X
SDTM0213
WebSDM
IR4132
(IR5132)
Identifies records that violate the condition [Planned Time Point Number (**TPTNUM) is not null], limited to records where [Planned Time Point Name (**TPT) is not null].
_ALL_
[**TPT][**TPTNUM]
X
X
SDTM0214
Janus
IR4133
Identifies records that violate the condition [Time Point Reference (**TPTREF) is not null], limited to records where [Elapsed Time from Reference Point (**ELTM) is not null].
_ALL_-PP
[**TPTREF][**ELTM]
X
SDTM0214
WebSDM
IR4133
(IR5133)
Identifies records that violate the condition [Time Point Reference (**TPTREF) is not null], limited to records where [Elapsed Time from Reference Point (**ELTM) is not null].
_ALL_-PP
[**TPTREF][**ELTM]
X
X
SDTM0215
WebSDM
IR4117
Identifies records that violate the condition [End Relative to Reference Period (**ENRF) is not null], limited to records where [End Date/Time of Observation (**ENDTC) is null] and [Occurrence (**OCCUR) does not equal 'N'].
AE+CM+MH+SU
[**ENRF][**ENDTC]
X
SDTM0215
OpenCDISC
SD0021
Identifies records that violate the condition [End relative to reference period (**ENRF) is not null], limited to records where [end date/time of observation (**ENDTC) is null] and [occurrence (**OCCUR) does not equal 'N'].
AE+CE+CM+MH+SU
[**ENRF]
[**ENDTC]
X
SDTM0216
WebSDM
IR4118
Identifies records that violate the condition [Start Relative to Reference Period (**STRF) is not null], limited to records where [Start Date/Time of Observation (**STDTC) is null] and [Occurrence (**OCCUR) does not equal 'N'].
CM+SU
[**STRF][**STDTC]
X
SDTM0216
OpenCDISC
SD022
Identifies records that violate the condition [start relative to reference period (**STRF) is not null], limited to records where [start date/time of observation (**STDTC) is null] and [occurrence (**OCCUR) does not equal 'N'].
CE+CM+SU
[**STRF]
[**STDTC]
X
SDTM0217
JanusFR
IR4120
Identifies records that violate the condition [Evaluation Interval (**EVLINT) greater than or equal to 0], limited to records where **EVLINT is not null.
_ALL_
**EVLINT
X
SDTM0217
WebSDM
IR4120
Identifies records that violate the condition [Evaluation Interval (**EVLINT) greater than or equal to 0], limited to records where **EVLINT is not null.
_ALL_
**EVLINT
X
SDTM0218
Janus
IR4107
Identifies records that violate the condition [Status (**STAT) equals NOT DONE ], limited to records where **STAT is not null.
_ALL_
**STAT
X
SDTM0218
WebSDM
IR4107
(IR5107)
Identifies records that violate the condition [Status (**STAT) equals NOT DONE ], limited to records where **STAT is not null.
_ALL_
**STAT
X
X
SDTM0219
Janus
IR4122
Identifies records that violate the condition [Reason Not Done (**REASND) is null], limited to records where [Status (**STAT) is null].
CM+EG+LB+MH+PE+QS+SC+SU+VS
[**REASND][**STAT]
X
SDTM0219
WebSDM
IR4122
(IR5122)
Identifies records that violate the condition [Reason Not Done (**REASND) is null], limited to records where [Status (**STAT) is null].
CM+EG+LB+MH+PE+QS+SC+SU+VS
[**REASND][**STAT]
X
SDTM0219
WebSDM
IR5122
Identifies records that violate the condition [reason not done (**REASND) is null], limited to records where [status (**STST) is null].
_ALL_
[**REASND]
[**STAT]
X
SDTM0220
Janus
IR4110
Identifies records that violate the condition [Duration (**DUR) greater than or equal to 0], limited to records where **DUR is not null.
_ALL_
**DUR
X
SDTM0220
WebSDM
IR4110
(IR5110)
Identifies records that violate the condition [Duration (**DUR) greater than or equal to 0], limited to records where **DUR is not null.
_ALL_
**DUR
X
X
SDTM0221
Janus
IR4136
Identifies records where values are not found in the study-specific codelist attached to a variable.
_ALL_
X
SDTM0221
WebSDM
IR4136
(IR5136)
Identifies records where values are not found in the study-specific codelist attached to a variable.
_ALL_
X
X
SDTM0222
Janus
IR4137
Identifies records that violate the condition [Study Day of Visit/Collection/Exam (**DY) does not equal 0].
_ALL_
**DY+**STDY+**ENDY+VISITDY
X
SDTM0222
WebSDM
IR4137
(IR5137)
Identifies records that violate the condition [Study Day of Visit/Collection/Exam (**DY) does not equal 0].
_ALL_
**DY+**STDY+**ENDY+VISITDY
X
X
SDTM0223
SAS
SAS0030
Identifies records with the condition [Subcategory (**SCAT) is not null when category of related records (**CAT) is null].
AE+CM+DS+EG+EX+IE+LB+MH+QS+SC+SU+VS
[**SCAT][**CAT]
X
SDTM0223
SAS
SAS0030
Identifies records with the condition [subcategory (**SCAT) is not null when category of related records (**CAT) is null].
_ALL_-TI
[**SCAT]
[**CAT]
X
SDTM0223
SAS
SAS0030
Identifies records with the condition [subcategory (**SCAT) is not null when category of related records (**CAT) is null].
TI
[IESCAT]
[IECAT]
X
SDTM0225
WebSDM
IR5162
Identifies records that violate the condition [result or finding in original units cannot be null unless status='NOT DONE'], limited to records where [derived flag does not equal 'Y'].
CLASS-FINDINGS-IE
[**ORRES]
[**STAT]
X
X
SDTM0226
WebSDM
IR5163
Identifies records that violate the condition [if non-null result or finding in original units is provided, then status must be null].
CLASS-FINDINGS-IE
[**ORRES]
[**STAT]
X
X
SDTM0231
OpenCDISC
SD1003
When age units (AGEU) are not null, then age (AGE) should be provided.
DM
[AGE]
[AGEU]
X
SDTM0232
OpenCDISC
SD1010
When subjects experience for a particular period of time is represented as an unplanned element, where element code (ETCD) is equal to 'UNPLAN”, then the description element (ELEMENT) should be null.
SE
[ETCD]
[ELEMENT]
X
SDTM0233
OpenCDISC
SD1019
For unplanned visits where the description of the unplanned visit (SVUPDES) is populated, the planned study day of visit (VISITDY) should be null.
SV
[SVUPDES]
[VISITDY]
X
SDTM0251
Janus
IR4121
Identifies records that violate the condition [Toxicity Grade (**TOXGR) is a valid number], limited to records where **TOXGR is not null.
CLASS:EVENTS
**TOXGR
X
SDTM0251
SAS
IR4121
Identifies records that violate the condition [toxicity grade (**TOXGR) is a valid number], limited to records where **TOXGR is not null.
_ALL_
**TOXGR
X
SDTM0251
WebSDM
IR5121
Identifies records that violate the condition [Toxicity Grade (**TOXGR) is a valid number], limited to records where **TOXGR is not null.
_ALL_
**TOXGR
X
SDTM0251
WebSDM
IR4121
Identifies records that violate the condition [Toxicity Grade (**TOXGR) is a valid number], limited to records where **TOXGR is not null.
CLASS:EVENTS
**TOXGR
X
SDTM0271
SAS
SAS0036
Value for column defined as a data set key is null.
_ALL_
X
X
SDTM0301
JanusFR
IR4104
Identifies records that violate the condition [End Relative to Reference Period (**ENRF) in ( BEFORE , DURING , AFTER , DURING/AFTER , U )], limited to records where **ENRF is not null.
CLASS:EVENTS+CLASS:INTERVENTIONS
**ENRF
X
SDTM0301
WebSDM
IR4104
(IR5104)
Identifies records that violate the condition [End Relative to Reference Period (**ENRF) in ( BEFORE , DURING , AFTER , DURING/AFTER , U )], limited to records where **ENRF is not null.
CLASS:EVENTS+CLASS:INTERVENTIONS
**ENRF
X
X
SDTM0302
JanusFR
IR4106
Identifies records that violate the condition [Occurrence (**OCCUR) in ( Y , N )], limited to records where **OCCUR is not null.
CLASS:EVENTS+CLASS:INTERVENTIONS
**OCCUR
X
SDTM0302
WebSDM
IR4106
(IR5106)
Identifies records that violate the condition [Occurrence (**OCCUR) in ( Y , N )], limited to records where **OCCUR is not null.
CLASS:EVENTS+CLASS:INTERVENTIONS
**OCCUR
X
X
SDTM0303
JanusFR
IR4108
Identifies records that violate the condition [Start Relative to Reference Period (**STRF) in ( BEFORE , DURING , AFTER ,'U')], limited to records where **STRF is not null.
CLASS:EVENTS+CLASS:INTERVENTIONS
**STRF
X
SDTM0303
WebSDM
IR4108
(IR5108)
Identifies records that violate the condition [Start Relative to Reference Period (**STRF) in ( BEFORE , DURING , AFTER ,'U')], limited to records where **STRF is not null.
CLASS:EVENTS+CLASS:INTERVENTIONS
**STRF
X
X
SDTM0351
JanusFR
IR4134
Identifies records that violate the condition [Dose units (**DOSU) is not null], limited to records where [Dose (**DOSE) is not null] and (Standard) Core attribute is 'Perm'.
CLASS:INTERVENTIONS
[**DOSE][**DOSU]
X
SDTM0351
WebSDM
IR4134
(IR5134)
Identifies records that violate the condition [Dose units (**DOSU) is not null], limited to records where [Dose (**DOSE) is not null] and (Standard) Core attribute is 'Perm'.
CLASS:INTERVENTIONS
[**DOSE][**DOSU]
X
X
SDTM0352
JanusFR
IR4109
Identifies records that violate the condition [Dose (**DOSE) greater than or equal to 0], limited to records where **DOSE is not null.
CLASS:INTERVENTIONS
**DOSE
X
SDTM0352
WebSDM
IR4109
(IR5109)
Identifies records that violate the condition [Dose (**DOSE) greater than or equal to 0], limited to records where **DOSE is not null.
CLASS:INTERVENTIONS
**DOSE
X
X
SDTM0353
JanusFR
IR4138
Identifies records that violate the condition [Dose units (**DOSU) is not null], limited to records where [Dose (**DOSE) is not null] and (Standard) Core attribute is 'Exp'.
CLASS:INTERVENTIONS
[**DOSE][**DOSU]
X
SDTM0353
WebSDM
IR4138
(IR5138)
Identifies records that violate the condition [Dose units (**DOSU) is not null], limited to records where [Dose (**DOSE) is not null] and (Standard) Core attribute is 'Exp'.
CLASS:INTERVENTIONS
[**DOSE][**DOSU]
X
X
SDTM0354
WebSDM
IR4139
(IR5139)
Identifies records that violate the condition [Related Domain (RDOMAIN) is not null].
SUPP**+RELREC
RDOMAIN
X
X
SDTM0355
SAS
SAS0040
Value for Related Domain (RDOMAIN) is inconsistent with data set name.
SUPP**-SUPPQUAL
RDOMAIN
X
X
SDTM0401
Janus
IR4102
Identifies records that violate the condition [Baseline Flag (**BLFL) either 'Y' or null].
CLASS:FINDINGS
**BLFL
X
SDTM0401
WebSDM
IR4102
(IR5102)
Identifies records that violate the condition [Baseline Flag (**BLFL) either 'Y' or null].
CLASS:FINDINGS
**BLFL
X
X
SDTM0402
JanusFR
IR4103
Identifies records that violate the condition [Derived Flag (**DRVFL) either 'Y' or null].
CLASS:FINDINGS
**DRVFL
X
SDTM0402
WebSDM
IR4103
(IR5103)
Identifies records that violate the condition [Derived Flag (**DRVFL) either 'Y' or null].
CLASS:FINDINGS
**DRVFL
X
X
SDTM0403
JanusFR
IR4105
Identifies records that violate the condition [Fasting Status (**FAST) in ( Y , N , U )], limited to records where **FAST is not null.
CLASS:FINDINGS
**FAST
X
SDTM0403
WebSDM
IR4105
(IR5105)
Identifies records that violate the condition [Fasting Status (**FAST) in ( Y , N , U )], limited to records where **FAST is not null.
CLASS:FINDINGS
**FAST
X
X
SDTM0405
Janus
IR4112
Identifies records that violate the condition [Result or Finding in Standard Format (**STRESC) is not null], limited to records where [Derived Flag (**DRVFL) equals 'Y'].
CLASS:FINDINGS-DA-IE-PE-PP-SC
[**STRESC][**DRVFL]
X
SDTM0405
WebSDM
IR4112
(IR5112)
Identifies records that violate the condition [Result or Finding in Standard Format (**STRESC) is not null], limited to records where [Derived Flag (**DRVFL) equals 'Y'].
CLASS:FINDINGS-DA-IE-PE-PP-SC
[**STRESC][**DRVFL]
X
X
SDTM0406
Janus
IR4123
Identifies records that violate the condition [Date/Time of Collection (**DTC) is not null], limited to records where [End Date/Time of Observation (**ENDTC) is not null].
LB
[LBDTC][LBENDTC]
X
SDTM0406
WebSDM
IR4123
Identifies records that violate the condition [Date/Time of Collection (**DTC) is not null], limited to records where [End Date/Time of Observation (**ENDTC) is not null].
LB
[LBDTC][LBENDTC]
X
SDTM0406
WebSDM
IR5123
Identifies records that violate the condition [date/time of collection (**DTC) is not null], limited to records where [end date/time of observation (**ENDTC) is not null].
LB+MH+PC
[**DTC]
[**ENDTC]
X
SDTM0407
JanusFR
IR4124
Identifies records that violate the condition [Date/Time of Collection (**DTC) less than or equal to End Date/Time of Observation (**ENDTC)], limited to records where **DTC is not null and **ENDTC exists.
LB
[LBDTC][LBENDTC]
X
SDTM0407
WebSDM
IR4124
Identifies records that violate the condition [Date/Time of Collection (**DTC) less than or equal to End Date/Time of Observation (**ENDTC)], limited to records where **DTC is not null and **ENDTC exists.
LB
[LBDTC][LBENDTC]
X
SDTM0407
WebSDM
IR5124
Identifies records that violate the condition [date/time of collection (**DTC) less than or equal to end date/time of observation (**ENDTC)], limited to records where **DTC is not null and **ENDTC exists.
LB+MH+PC
[**DTC]
[**ENDTC]
X
SDTM0408
Janus
IR4125
Identifies records that violate the condition [Original units (**ORRESU) is not null], limited to records where [Result or Finding in Original Units (**ORRES) is not null].
CLASS:FINDINGS-IE
[**ORRES][**ORRESU]
X
SDTM0408
WebSDM
IR4125
(IR5125)
Identifies records that violate the condition [Original units (**ORRESU) is not null], limited to records where [Result or Finding in Original Units (**ORRES) is not null].
CLASS:FINDINGS-IE
[**ORRES][**ORRESU]
X
X
SDTM0409
Janus
IR4126
Identifies records that violate the condition [Original units (**ORRESU) is null], limited to records where [Result or Finding in Original Units (**ORRES) is null].
CLASS:FINDINGS-IE
[**ORRES][**ORRESU]
X
SDTM0409
WebSDM
IR4126
Identifies records that violate the condition [Original units (**ORRESU) is null], limited to records where [Result or Finding in Original Units (**ORRES) is null].
CLASS:FINDINGS-IE
[**ORRES][**ORRESU]
X
X
SDTM0410
JanusFR
IR4127
Identifies records that violate the condition [Normal Range Upper Limit-Standard Units (**STNRHI) greater than or equal to Normal Range Lower Limit-Standard Units (**STNRLO)], limited to records where **STNRHI is not null and **STNRLO is not null.
CLASS:FINDINGS
[**STNRHI][**STNRLO]
X
SDTM0410
WebSDM
IR4127
Identifies records that violate the condition [Normal Range Upper Limit-Standard Units (**STNRHI) greater than or equal to Normal Range Lower Limit-Standard Units (**STNRLO)], limited to records where **STNRHI is not null and **STNRLO is not null.
CLASS:FINDINGS
[**STNRHI][**STNRLO]
X
SDTM0410
WebSDM
IR5127
Identifies records that violate the condition [normal range upper limit-standard units (**STNRLO)], limited to records where **STNRHI is not null and **STNRLO is not null.
LB
[LBSTNRHI]
[LBSTNRLO]
X
SDTM0411
SAS
SAS0029
Identifies records that violate the condition [Normal Range Upper Limit-Standard Units (**STNRHI) is null and Normal Range Lower Limit-Standard Units (**STNRLO) is null], or the condition [**STNRHI is not null and **STNRLO is not null].
CLASS:FINDINGS
[**STNRHI][**STNRLO]
X
X
SDTM0412
Janus
IR4128
Identifies records that violate the condition [Standard Units (**STRESU) is not null], limited to records where [Result or Finding in Standard Format (**STRESC) is not null].
CLASS:FINDINGS-IE
[**STRESC][**STRESU]
X
SDTM0412
WebSDM
IR4128
Identifies records that violate the condition [Standard Units (**STRESU) is not null], limited to records where [Result or Finding in Standard Format (**STRESC) is not null].
CLASS:FINDINGS-IE
[**STRESC][**STRESU]
X
SDTM0412
WebSDM
IR5128
Identifies records that violate the condition [standard units (**STRESU) are not null], limited to records where [result or finding in standard format (**STRESC) is not null].
CLASS:FINDINGS-IE-PE
[**STRESC]
[**STRESU]
X
SDTM0413
Janus
IR4129
Identifies records that violate the condition [Standard Units (**STRESU) is null], limited to records where [Result or Finding in Standard Format (**STRESC) is null].
CLASS:FINDINGS-IE
[**STRESC][**STRESU]
X
SDTM0413
WebSDM
IR4129
Identifies records that violate the condition [Standard Units (**STRESU) is null], limited to records where [Result or Finding in Standard Format (**STRESC) is null].
CLASS:FINDINGS-IE
[**STRESC][**STRESU]
X
SDTM0413
WebSDM
IR5129
Identifies records that violate the condition [standard units (**STRESU) is null], limited to records where [result or finding in standard format (**STRESC) is null].
CLASS:FINDINGS-IE-PE
[**STRESC]
[**STRESU]
X
SDTM0414
JanusFR
IR4135
Identifies records that violate the condition [Result or Finding in Standard Format (**STRESC) is not null], limited to records where [Result or Finding in Original Units (**ORRES) is not null].
CLASS:FINDINGS
[**ORRES][**STRESC]
X
SDTM0414
WebSDM
IR4135
(IR5135)
Identifies records that violate the condition [Result or Finding in Standard Format (**STRESC) is not null], limited to records where [Result or Finding in Original Units (**ORRES) is not null].
CLASS:FINDINGS
[**ORRES][**STRESC]
X
X
SDTM0415
WebSDM
IR5143
Identifies records that violate the condition [if non-null occurrence (**OCCUR) is provided, then pre-specified (**PRESP) must equal 'Y'].
CE+CM+SU+MH
[**OCCUR]
[**PRESP]
X
SDTM0416
WebSDM
IR5144
Identifies records that violate the condition [if non-null occurrence (**OCCUR) is provided and pre-specified (**PRESP) equal 'Y', then completion status (**STAT) must equal 'NOT DONE'].
CLASS:EVENTS+CLASS:INTERVENTIONS
[**OCCUR]
[**STAT]
X
SDTM0417
WebSDM
IR5145
Identifies records that violate the condition [treatment vehicle (**TRTV) is not null], limited to records where [treatment vehicle amount (**VAMT) is not null].
EX
[**TRTV]
[**VAMT]
X
SDTM0418
WebSDM
IR5146
Identifies records that violate the condition [treatment vehicle amount units (**VAMTU) is not null], limited to records where [treatment vehicle amount (**VAMT) is not null].
EX
[**VAMTU]
[**VAMT]
X
SDTM0419
WebSDM
IR5147
Identifies records that violate the condition [result or finding in standard format (**STRESC) is not null], limited to records where [result category (**RESCAT) is not null].
MB+MS
[**STRESC]
[**RESCAT]
X
SDTM0422
WebSDM
IR5168
Identifies records that violate the condition [if non-null start relative to reference time point (**STRTPT) is provided, then start reference time point (**STTPT) must be non-null].
_ALL_
[**STRTPT]
[**STTPT]
X
SDTM0423
WebSDM
IR5169
Identifies records that violate the condition [if non-null end relative to reference time point (**ENRTPT) is provided, then the end reference time point (**ENTPT) must be non-null].
_ALL_
[**ENRTPT]
[**ENTPT]
X
SDTM0441
WebSDM
IR5255
Identifies a sponsor-derived flag variable for 'treatment emergent AE' where the derivation cannot be executed.
SUPPAE
AETERM
X
SDTM0442
WebSDM
IR5256
Identifies a sponsor-derived flag variable for 'clinically significant lab' where the derivation cannot be executed.
SUPPLB
LBCLSIG
X
SDTM0443
WebSDM
IR5257
Identifies a sponsor-derived flag variable for 'clinically significant vital sign' where the derivation cannot be executed.
SUPPVS
VSCLSIG
X
SDTM0449
WebSDM
IR5141
Identifies user-defined codelist values that are not found in the corresponding SDTM codelist.
_ALL_
X
SDTM0450
SAS
SAS0037
Identifies records where the lookup value for a coded field (such as **DECOD, **BODSYS or **LOINC) could not be found in the associated dictionary.
_ALL_
**DECOD
X
X
SDTM0451
JanusFR
IR4007
Identifies records where the value for the preferred term could not be found in the MedDRA dictionary.
AE
AEDECOD
X
SDTM0451
WebSDM
IR4007
(IR5007)
Identifies records where the value for the preferred term could not be found in the MedDRA dictionary.
AE
AEDECOD
X
X
SDTM0452
Janus
IR4008
Identifies records where Serious Event (AESER)='Y' but none of Involves Cancer (AESCAN), Congenital Anomaly or Birth Defect (AESCONG), Persist or Signif Disability/Incapacity (AESDISAB), Results in Death (AESDTH), Requires or Prolongs Hospitalization (AESHOSP), Is Life Threatening (AESLIFE), Other Medically Important Serious Event (AESMIE), or Occurred with Overdose (AESOD) equals 'Y'.
AE
AESER
X
SDTM0452
WebSDM
IR4008
(IR5008)
Identifies records where Serious Event (AESER)='Y' but none of Involves Cancer (AESCAN), Congenital Anomaly or Birth Defect (AESCONG), Persist or Signif Disability/Incapacity (AESDISAB), Results in Death (AESDTH), Requires or Prolongs Hospitalization (AESHOSP), Is Life Threatening (AESLIFE), Other Medically Important Serious Event (AESMIE), or Occurred with Overdose (AESOD) equals 'Y'.
AE
AESER
X
X
SDTM0453
JanusFR
R4019
Identifies records where value for [Serious Event (AESER)] is not found in codelist [YESNO].
AE
AESER
X
SDTM0453
WebSDM
R4019
(IR5019)
Identifies records where value for [Serious Event (AESER)] is not found in Codelist [YESNO].
AE
AESER
X
X
SDTM0454
JanusFR
R4023
Identifies records where value for [Congenital Anomaly or Birth Defect (AESCONG)] is not found in Codelist [YESNO], limited to records where AESCONG is not null.
AE
AESCONG
X
SDTM0454
WebSDM
R4023
(IR5023)
Identifies records where value for [Congenital Anomaly or Birth Defect (AESCONG)] is not found in Codelist [YESNO], limited to records where AESCONG is not null
AE
AESCONG
X
X
SDTM0455
JanusFR
R4024
Identifies records where value for [Persist or Signif Disability/Incapacity (AESDISAB)] is not found in Codelist [YESNO], limited to records where AESDISAB is not null.
AE
AESDISAB
X
SDTM0455
WebSDM
R4024
(IR5024)
Identifies records where value for [Persist or Signif Disability/Incapacity (AESDISAB)] is not found in Codelist [YESNO], limited to records where AESDISAB is not null.
AE
AESDISAB
X
X
SDTM0456
JanusFR
R4025
Identifies records where value for [Results in Death (AESDTH)] is not found in Codelist [YESNO], limited to records where AESDTH is not null.
AE
AESDTH
X
SDTM0456
WebSDM
R4025
(R5025)
Identifies records where value for [Results in Death (AESDTH)] is not found in Codelist [YESNO], limited to records where AESDTH is not null.
AE
AESDTH
X
X
SDTM0457
JanusFR
R4026
Identifies records where value for [Requires or Prolongs Hospitalization (AESHOSP)] is not found in Codelist [YESNO], limited to records where AESHOSP is not null.
AE
AESHOSP
X
SDTM0457
WebSDM
R4026
(R5026)
Identifies records where value for [Requires or Prolongs Hospitalization (AESHOSP)] is not found in Codelist [YESNO], limited to records where AESHOSP is not null.
AE
AESHOSP
X
X
SDTM0458
JanusFR
R4027
Identifies records where value for [Is Life Threatening (AESLIFE)] is not found in Codelist [YESNO], limited to records where AESLIFE is not null.
AE
AESLIFE
X
SDTM0458
WebSDM
R4027
(R5027)
Identifies records where value for [Is Life Threatening (AESLIFE)] is not found in Codelist [YESNO], limited to records where AESLIFE is not null.
AE
AESLIFE
X
X
SDTM0459
JanusFR
R4045
Identifies records where value for [Involves Cancer (AESCAN)] is not found in Codelist [YESNO], limited to records where AESCAN is not null.
AE
AESCAN
X
SDTM0459
WebSDM
R4045
(R5045)
Identifies records where value for [Involves Cancer (AESCAN)] is not found in Codelist [YESNO], limited to records where AESCAN is not null.
AE
AESCAN
X
X
SDTM0460
JanusFR
R4046
Identifies records where value for [Other Medically Important Serious Event (AESMIE)] is not found in Codelist [YESNO], limited to records where AESMIE is not null.
AE
AESMIE
X
SDTM0460
WebSDM
R4046
(R5046)
Identifies records where value for [Other Medically Important Serious Event (AESMIE)] is not found in Codelist [YESNO], limited to records where AESMIE is not null.
AE
AESMIE
X
X
SDTM0461
JanusFR
R4047
Identifies records where value for [Occurred with Overdose (AESOD)] is not found in Codelist [YESNO], limited to records where AESOD is not null.
AE
AESOD
X
SDTM0461
WebSDM
R4047
(R5047)
Identifies records where value for [Occurred with Overdose (AESOD)] is not found in Codelist [YESNO], limited to records where AESOD is not null.
AE
AESOD
X
X
SDTM0462
Janus
R4102
Identifies records that violate the condition [Results in Death (AESDTH)= Y ], limited to records where [Outcome of Adverse Event (AEOUT)='FATAL'].
AE
[AESDTH][AEOUT]
X
SDTM0462
WebSDM
R4102
(R5102)
Identifies records that violate the condition [Results in Death (AESDTH)= Y ], limited to records where [Outcome of Adverse Event (AEOUT)='FATAL'].
AE
[AESDTH][AEOUT]
X
X
SDTM0463
Janus
R4103
Identifies records that violate the condition [Outcome of Adverse Event (AEOUT)='FATAL'], limited to records where [Results in Death (AESDTH)='Y'].
AE
[AESDTH][AEOUT]
X
SDTM0463
WebSDM
R4103
(R5103)
Identifies records that violate the condition [Outcome of Adverse Event (AEOUT)='FATAL'], limited to records where [Results in Death (AESDTH)='Y'].
AE
[AESDTH][AEOUT]
X
X
SDTM0464
JanusFR
R4043
Identifies records where value for [Concomitant or Additional Trtmnt Given (AECONTRT)] is not found in Codelist [YESNO], limited to records where AECONTRT is not null.
AE
AECONTRT
X
SDTM0464
WebSDM
R4043
(R5043)
Identifies records where value for [Concomitant or Additional Trtmnt Given (AECONTRT)] is not found in Codelist [YESNO], limited to records where AECONTRT is not null.
AE
AECONTRT
X
X
SDTM0465
WebSDM
R5108
Identifies records where value for [action taken with study treatment (AEACN)] is not found in codelist [ACN], limited to records where AEACN is not null.
AE
AEACN
X
SDTM0466
WebSDM
R5109
Identifies records where value for [outcome of adverse event (AEOUT)] is not found in codelist [OUT], limited to records where AEOUT is not null.
AE
AEOUT
X
SDTM0467
WebSDM
R5110
Identifies records where value for [severity or intensity (AESEV)] is not found in codelist [AESEV], limited to records where AESEV is not null.
AE
AESEV
X
SDTM0470
OpenCDISC
CT0003
Variable values should be populated with terms found in AGESPAN (C66780) CDISC controlled terminology codelist.
TS
TSVAL
X
SDTM0471
OpenCDISC
CT0005
Variable values should be populated with terms found in AGEU (C66781) CDISC terminology codelist.
TS
TSVAL
X
SDTM0472
OpenCDISC
CT0007
Variable values should be populated with terms found in drug accountability test name (C66731) CDISC controlled terminology codelist.
DA
DATEST
X
SDTM0473
OpenCDISC
CT0008
Variable values should be populated with terms found in drug accountability test code (C66732) CDISC controlled terminology codelist.
DA
DATESTCD
X
SDTM0474
OpenCDISC
CT0009
Variable values should be populated with terms found in 'Domain Abbreviation' (C66734) CDISC controlled terminology codelist.
_ALL_
DOMAIN
X
SDTM0475
OpenCDISC
CT0016
Variable values should be populated with terms found in evaluator (C78735) CDISC controlled terminology codelist.
CLASS:FINDINGS
**EVAL
X
SDTM0476
OpenCDISC
CT0017
Variable values should be populated with terms found in evaluator (C78735) CDISC controlled terminology codelist.
SUPP**
QEVAL
X
SDTM0477
OpenCDISC
CT0024
Variable values should be populated with terms found in MARISTAT (C76348) CDISC controlled terminology codelist.
SC
SCSTRESC
X
SDTM0478
OpenCDISC
CT0026
Variable values should be populated with terms found in 'Reference Range Indicator' (C78736) CDISC controlled terminology codelist.
CLASS:FINDINGS
**NRIND
X
SDTM0479
OpenCDISC
CT0032
Variable values should be populated with terms found in ROUTE (C66729) CDISC controlled terminology codelist.
TS
TSVAL
X
SDTM0480
OpenCDISC
CT0035
Variable values should be populated with terms found in SEXPOP (C66732) CDISC controlled terminology codelist.
TS
TSVAL
X
SDTM0481
OpenCDISC
CT0037
Variable values should be populated with terms found in AGESPAN (C66780) CDISC controlled terminology codelist.
CLASS:FINDINGS+CLASS:EVENTS
**BODSYS
X
SDTM0482
OpenCDISC
CT0040
Variable values should be populated with terms found in TBLIND (C66735) CDISC controlled terminology codelist.
TS
TSVAL
X
SDTM0483
OpenCDISC
CT0041
Variable values should be populated with terms found in TCNTRL (C66785) CDISC controlled terminology codelist.
TS
TSVAL
X
SDTM0484
OpenCDISC
CT0042
Variable values should be populated with terms found in TDIGRP (C66787) CDISC controlled terminology codelist.
TS
TSVAL
X
SDTM0485
OpenCDISC
CT0043
Variable values should be populated with terms found in TINDTP (C66736) CDISC controlled terminology codelist.
TS
TSVAL
X
SDTM0486
OpenCDISC
CT0045
Variable values should be populated with terms found in TPHASE (C66737) CDISC controlled terminology codelist.
TS
TSVAL
X
SDTM0487
OpenCDISC
CT0046
Variable values should be populated with terms found in Trial Summary Parameter Test Name (C67152) CDISC controlled terminology codelist.
TS
TSPARM
X
SDTM0488
OpenCDISC
CT0047
Variable values should be populated with terms found in Trial Summary Parameter Test Code (C66738) CDISC controlled terminology codelist.
TS
TSPARMCD
X
SDTM0489
OpenCDISC
CT0035
Variable values should be populated with terms found in TTYPE (C66739) CDISC controlled terminology codelist.
TS
TSVAL
X
SDTM0490
WebSDM
IR5150
Identifies records that violate the condition [Pre-specified (**PRESP) is either 'Y' or null].
_ALL_
**PRESP
X
SDTM0491
WebSDM
IR5159
Identifies records that violate the condition [route of administration (**ROUTE) is in codelist ROUTE or is null].
CLASS:INTERVENTIONS
**ROUTE
X
SDTM0492
WebSDM
IR5164
Identifies records that violate the condition [position of subject during observation (**POS) is in codelist POSITION or is null].
CLASS:FINDINGS
**POS
X
SDTM0493
WebSDM
IR5165
Identifies records that violate the condition [start relative to reference time point (**STRTPT) is in codelist STRTPT or is null].
_ALL_
**STRTPT
X
SDTM0494
WebSDM
IR5166
Identifies records that violate the condition [end relative to reference time point (**ENRTPT) is in codelist ENRTPT or is null].
_ALL_
**ENRTPT
X
SDTM0495
WebSDM
IR5173
Identifies records that violate the condition [dose units (**DOSU) is in codelist UNIT or is null].
_ALL_
**DOSU
X
SDTM0496
WebSDM
IR5174
Identifies records that violate the condition [Original Units (**ORRESU) is in codelist UNIT or is null].
_ALL_-VS
**ORRESU
X
SDTM0497
WebSDM
IR5175
Identifies records that violate the condition [Standard Units (**STRESU) is in codelist UNIT or is null].
_ALL_-VS
**STRESU
X
SDTM0498
WebSDM
IR5176
Identifies records that violate the condition [location used for the measurement (**LOC) is in codelist LOC or is null].
_ALL_
**LOC
X
SDTM0499
WebSDM
IR5177
Identifies records that violate the condition [dosing frequency per interval (**DOSFRQ) is in codelist FREQ or is null].
CLASS:INTERVENTIONS
**DOSFRQ
X
SDTM0500
WebSDM
IR4172
(R5172)
Identifies records that violate the condition [if arm code (ARMCD)='NOTASSGN' then description of arm (ARM) must equal 'Not Assigned', and vice versa].
DM+TA
[ARM]
[ARMCD]
X
X
SDTM0501
Janus
IR4011
Identifies records that violate the condition [If Arm Code (ARMCD)='SCRNFAIL' then Description of Arm (ARM) must equal 'Screen Failure', and vice versa].
DM
[ARM][ARMCD]
X
SDTM0501
WebSDM
IR4011
(ir5011)
Identifies records that violate the condition [If Arm Code (ARMCD)='SCRNFAIL' then Description of Arm (ARM) must equal 'Screen Failure', and vice versa].
DM+TA
[ARM][ARMCD]
X
X
SDTM0502
JanusFR
R4096
Identifies records that violate the condition [Subject Reference Start Date and Time (RFSTDTC) is not null], limited to records where upper(Arm Code (ARMCD)) does not equal 'SCRNFAIL'.
DM
[RFSTDTC][ARMCD]
X
SDTM0502
WebSDM
R4096
(R5096)
Identifies records that violate the condition [Subject Reference Start Date and /Time (RFSTDTC) is not null], limited to records where upper(Arm Code (ARMCD)) does not equal 'SCRNFAIL'.
DM
[RFSTDTC][ARMCD]
X
X
SDTM0503
JanusFR
R4097
Identifies records that violate the condition [Subject Reference End Date and Time (RFENDTC) is not null], limited to records where upper(Arm Code (ARMCD)) does not equal 'SCRNFAIL'.
DM
[RFENDTC][ARMCD]
X
SDTM0503
WebSDM
R4097
(R5097)
Identifies records that violate the condition [Subject Reference End Date and Time (RFENDTC) is not null], limited to records where upper(Arm Code (ARMCD)) does not equal 'SCRNFAIL'.
DM
[RFENDTC][ARMCD]
X
X
SDTM0504
JanusFR
R4007
Identifies records where value for [SEX] is not found in codelist [SEX].
DM
SEX
X
SDTM0504
WebSDM
R4007
(R5007)
Identifies records where value for [SEX] is not found in codelist [SEX].
DM
SEX
X
X
SDTM0505
Janus
R4008
Identifies records where value for [COUNTRY] is not found in codelist [COUNTRY].
DM
COUNTRY
X
SDTM0505
WebSDM
R4008
(R5008)
Identifies records where value for [COUNTRY] is not found in codelist [COUNTRY].
DM
COUNTRY
X
X
SDTM0506
JanusFR
R4006
Identifies records that violate the condition [age (AGE) greater than or equal to 0], limited to records where AGE is not null.
DM
AGE
X
SDTM0506
WebSDM
R4006
(R5006)
Identifies records that violate the condition [age (AGE) greater than or equal to 0], limited to records where AGE is not null.
DM
AGE
X
X
SDTM0507
Janus
R4106
Identifies records that violate the condition [age units (AGEU) is not null], limited to records where AGE is not null.
DM
[AGE][AGEU]
X
SDTM0507
WebSDM
R4106
(R5106)
Identifies records that violate the condition [age units (AGEU) is not null], limited to records where AGE is not null.
DM
[AGE][AGEU]
X
X
SDTM0508
JanusFR
R4062
Identifies records where value for [age units (AGEU)] is not found in codelist [AGEUNITS2], limited to records where AGEU is not null.
DM
AGEU
X
SDTM0508
WebSDM
R4062
(R5062)
Identifies records where value for [age units (AGEU)] is not found in codelist [AGEUNITS2], limited to records where AGEU is not null.
DM
AGEU
X
X
SDTM0509
WebSDM
R5113
Identifies records where value for [ethnicity (ETHNIC)] is not found in codelist [ETHNIC], limited to records where ETHNIC is not null.
DM
ETHNIC
X
SDTM0510
WebSDM
R5130
Identifies records where value for [race] is not found in codelist [RACE], limited to records where [race is not null].
DM
RACE
X
SDTM0511
WebSDM
R5121
Identifies records that violate the condition [category for disposition event (DSCAT) = 'DISPOSITION EVENT'], limited to records where [epoch (EPOCH) is not null].
DS
[DSCAT]
[EPOCH]
X
SDTM0512
WebSDM
R5122
Identifies records where value for [category for disposition event (DSCAT)] is not found in codelist [DSCAT].
DS
DSCAT
X
SDTM0513
WebSDM
R5131
Identifies records where value for [subject characteristic short name (SCTESTCD)] is not found in codelist [SCCD].
SC
SCTESTCD
X
SDTM0514
WebSDM
R5126
Identifies records where value for [dose form (CMDOSFRM)] is not found in codelist [FRM], limited to records where [CMDOSFRM is not null].
CM
CMDOSFRM
X
SDTM0515
WebSDM
R5123
Identifies records where value for [ECG Test or Examination Name (EGTEST)] is not found in Codelist [EGTEST].
EG
EGTEST
X
SDTM0516
WebSDM
R5124
Identifies records where value for [ECG test or examination short name (EGTESTCD)] is not found in codelist [EGTESTCD].
EG
EGTESTCD
X
SDTM0517
WebSDM
R5125
Identifies records where value for [method of ECG rest (EGMETHOD)] is not found in codelist [EGMETHOD], limited to records where [EGMETHOD is not null].
EG
EGMETHOD
X
SDTM0518
WebSDM
R5129
Identifies records where value for [character result or finding in standard format (EGSTRESC)] is not found in codelist [EGSTRESC], limited to records where [EGSTRESC is not null].
EG
EGSTRESC
X
SDTM0521
Janus
IR4119
Identifies records that violate the condition [Planned Elapsed Time from Reference Point (**ELTM) greater than or equal to 0], limited to records where **ELTM is not null.
EX
EXELTM
X
SDTM0521
WebSDM
IR4119
(IR5119)
Identifies records that violate the condition [Planned Elapsed Time from Reference Point (**ELTM) greater than or equal to 0], limited to records where **ELTM is not null.
EX
EXELTM
X
SDTM0522
WebSDM
R5127
Identifies records where value for [dose form (EXDOSFRM)] is not found in codelist [FRM], limited to records where [EXDOSFRM is not null].
EX
EXDOSFRM
X
SDTM0523
WebSDM
R5128
Identifies records where value for [treatment vehicle amount units (EXVAMTU)] is not found in codelist [UNIT], limited to records where [EXVAMTU is not null].
EX
EXVAMTU
X
SDTM0531
JanusFR
R4031
Identifies records where value for [Inclusion or Exclusion Category (IECAT)] is not found in codelist [INCEX], limited to records where IECAT is not null.
IE
IECAT
X
SDTM0531
WebSDM
R4031
(R5031)
Identifies records where value for [Inclusion or Exclusion Category (IECAT)] is not found in codelist [INCEX], limited to records where IECAT is not null.
IE
IECAT
X
X
SDTM0532
JanusFR
R4071
Identifies records that violate the condition [I/E Criterion Original Result (IEORRES)] is not found in codelist[YESNO], limited to records where IEORRES is not null.
IE
IEORRES
X
SDTM0532
WebSDM
R4071
(R5071)
Identifies records that violate the condition [I/E Criterion Original Result (IEORRES)] is not found in codelist[YESNO], limited to records where IEORRES is not null.
IE
IEORRES
X
X
SDTM0533
JanusFR
R4072
Identifies records that violate the condition [I/E Criterion Original Result in Standard Format (IESTRESC)] is not found in codelist[YESNO], limited to records where IESTRESC is not null.
IE
IESTRESC
X
SDTM0533
WebSDM
R4072
(R5072)
Identifies records that violate the condition [I/E Criterion Original Result in Standard Format (IESTRESC)] is not found in codelist[YESNO], limited to records where IESTRESC is not null.
IE
IESTRESC
X
X
SDTM0534
Janus
R4073
Identifies records that violate the condition [I/E Criterion Original Result (IEORRES) = I/E Criterion Original Result in Std Format (IESTRESC)].
IE
[IEORRES][IESTRESC]
X
SDTM0534
WebSDM
R4073
(R5073)
Identifies records that violate the condition [I/E Criterion Original Result (IEORRES) = I/E Criterion Original Result in Std Format (IESTRESC)].
IE
[IEORRES][IESTRESC]
X
X
SDTM0541
Janus
R4105
Identifies records that violate the condition [Description of Unplanned Element (SEUPDES) is not null], limited to records where Subject Element Code (ETCD) ='UNPLAN'.
SE
[SEUPDES][ETCD]
X
SDTM0541
WebSDM
R4105
(R5105)
Identifies records that violate the condition [Description of Unplanned Element (SEUPDES) is not null], limited to records where Subject Element Code (ETCD) ='UNPLAN'.
SE
[SEUPDES][ETCD]
X
X
SDTM0551
JanusFR
IR4012
Identifies records that violate the condition [If Arm Code (ARMCD)='SCRNFAIL' then Description of Arm (ARM) must equal 'Screen Failure', and vice versa].
TA
[ARM][ARMCD]
X
SDTM0551
WebSDM
IR4012
(IR5012)
Identifies records that violate the condition [If Arm Code (ARMCD)='SCRNFAIL' then Description of Arm (ARM) must equal 'Screen Failure', and vice versa].
TA
[ARM][ARMCD]
X
SDTM0561
Janus
R4101
Identifies records that violate the condition [Rule for End of Element (TEENRL) is not null or Planned Duration of Element (TEDUR) is not null].
TE
[TEENRL][TEDUR]
X
SDTM0561
WebSDM
R4101
(R5101)
Identifies records that violate the condition [Rule for End of Element (TEENRL) is not null or Planned Duration of Element (TEDUR) is not null].
TE
[TEENRL][TEDUR]
X
X
SDTM0562
OpenCDISC
SD1008
When comments are related to a specific parent record or group of parent records in a domain, then the value of Date and Time of Comment (CODTC) should be null because the timing of the parent record or records is inherited by the comment record.
CO
CODTC
X
SDTM0570
WebSDM
R5114
Identifies records where value for [lab test or examination name (LBTEST)] is not found in codelist [LBTEST].
LB
LBTEST
X
SDTM0571
WebSDM
R5115
Identifies records where value for [lab test or examination code (LBTESTCD)] is not found in codelist [LBTESTCD].
LB
LBTESTCD
X
SDTM0572
WebSDM
R5116
Identifies records where value for [original units (VSORRESU)] is not found in codelist [VSRESU], limited to records where [VSORRESU is not null].
VS
VSORRESU
X
SDTM0573
WebSDM
R5117
Identifies records where value for [character result or finding in std format (VSSTRESC)] is not found in codelist [SIZE], limited to records where [vital signs test short name (VSTESTCD) = 'FRMSIZE'].
VS
VSSTRESC
X
SDTM0574
WebSDM
R5118
Identifies records where value for [standard units (VSSTRESU)] is not found in codelist [VSRESU], limited to records where [VSSTRESU is not null].
VS
VSSTRESU
X
SDTM0575
WebSDM
R5119
Identifies records where value for [vital signs test name (VSTEST)] is not found in codelist [VSTEST].
VS
VSTEST
X
SDTM0576
WebSDM
R5120
Identifies records where value for [vital signs test short name (VSTESTCD)] is not found in codelist [VSTESTCD].
VS
VSTESTCD
X
SDTM0580
WebSDM
R5112
Variable values should be populated with terms found in completion/reason for non-completion (C66727) CDISC controlled terminology codelist.
DS
DSDECOD
X
SDTM0601
SAS
SAS0013
Domain not sorted by keys as defined in standard.
_ALL_
X
X
SDTM0602
SAS
SAS0007
Records are not unique by the expected keys
_ALL_
X
X
SDTM0603
JanusFR
IR4004
Identifies records where non-unique values for Sequence Number variable (**SEQ) exist within a subject.
_ALL_-TS
**SEQ
X
SDTM0603
WebSDM
IR4004
(IR5004)
Identifies records where non-unique values for Sequence Number variable (**SEQ) exist within a subject.
_ALL_-TS
**SEQ
X
X
SDTM0604
SAS
SAS0009
Sequence Number (**SEQ) values are not consecutively incremented beginning at 1 for each USUBJID.
TS
TSSEQ
X
X
SDTM0604
SAS
SAS0009
Sequence Number (**SEQ) values are not consecutively incremented beginning at 1 for each USUBJID.
_ALL_-TS
**SEQ
X
X
SDTM0605
SAS
SAS0014
Report any variable for the domain that contains all missing or null values.
_ALL_
_ALL_
X
X
SDTM0606
JanusFR
SAS0022
Identify any column defined as numeric in the standard that contains non-numeric values.
_ALL_
X
SDTM606
SAS
SAS0022
Identify any columns defined as numeric in the standard that contains non-numeric values.
_ALL_
X
SDTM0607
JanusFR
SAS0038
Site Study Identifier (SITEID) is null for all records.
DM
SITEID
X
SDTM0607
SAS
SAS0038
Site study identifier (SITEID) is null for all records.
DM
SITEID
X
SDTM0621
WebSDM
IR4005
(IR5005)
Identifies subjects where there are no records with a value of 'Y' in the baseline flag variable (**BLFL), excluding Arm Code (ARMCD)='SCRNFAIL'.
EG+LB+QS+VS
**BLFL
X
X
SDTM0622
WebSDM
IR4142
(IR5142)
Inconsistency between test (**TEST) and test code (**TESTCD).
CLASS:FINDINGS
[**TEST][**TESTCD]
X
X
SDTM0623
SAS
SAS0027
Identifies Test Code (**TESTCD) values where Standard Units (**STRESU) value is not consistent across all records.
CLASS:FINDINGS-IE-PE
[**TESTCD][**STRESU]
X
X
SDTM0631
JanusFR
IR4006
Identifies Short Name of Measurement, Test, or Examination (**TESTCD) values where Standard Units (**STRESU) value is not consistent across all records.
EG+LB+QS+VS
[**TESTCD][**STRESU]
X
SDTM0631
WebSDM
IR4006
(IR5006)
Identifies Short Name of Measurement, Test, or Examination (**TESTCD) values where Standard Units (**STRESU) value is not consistent across all records.
EG+LB+QS+VS
[**TESTCD][**STRESU]
X
X
SDTM0641
JanusFR
R4005
Identifies records where values for Unique Subject ID (USUBJID) are not unique, limited to records where USUBJID is not null.
DM
X
SDTM0641
WebSDM
R4005
(R5005)
Identifies records where values for Unique Subject ID (USUBJID) are not unique, limited to records where USUBJID is not null.
DM
X
X
SDTM0642
SAS
SAS0028
Inconsistency between Description of Arm (ARM) and Arm Code (ARMCD) values across all records.
DM
[ARM][ARMCD]
X
X
SDTM0643
SAS
SAS0016
AGE precision inconsistent across records.
DM
AGE
X
X
SDTM0644
JanusFR
SAS0019
The current version of JANUS requires that the STUDYID column have the same value for all records within a study.
_ALL_-DM
STUDYID
X
SDTM0644
JanusFR
SAS0019
The current version of JANUS requires that the STUDYID column have the same value for all records within a study.
DM
STUDYID
X
SDTM0644
SAS
SAS0019
STUDYID should have the same value for all records within a study.
DM
STUDYID
X
SDTM0645
OpenCDISC
SD1005
Study identifier (STUDYID) values must match the STUDYID in demographics (DM) domain.
[_ALL_-DM][DM]
STUDYID
X
SDTM0661
JanusFR
IR4083
Identifies records where values for [Study Identifier (STUDYID), Unique Subject Identifier (USUBJID), Identifying Variable (IDVAR), Identifying Variable Value (IDVARVAL), and Qualifier Variable Name (QNAM)] variable or variables are not unique.
SUPP**
X
SDTM0661
WebSDM
IR4083
(IR5083)
Identifies records where values for [Study Identifier (STUDYID), Unique Subject Identifier (USUBJID), Identifying Variable (IDVAR), Identifying Variable Value (IDVARVAL), and Qualifier Variable Name (QNAM)] variable or variables are not unique.
SUPP**
X
X
SDTM0662
WebSDM
IR4161
(IR5161)
Identifies qualifier variable name (QNAM) where variable label value (Qualifier Variable Label QLABEL) is not consistent across all records.
SUPP**
[QNAM][QLABEL]
X
X
SDTM0671
SAS
SAS0032
Inconsistency between Trial Summary Parameter (TSPARM) and Trial Summary Parameter Short Name (TSPARMCD).
TS
[TSPARM][TSPARMCD]
X
X
SDTM0672
OpenCDISC
SD0083
The value of unique subject identifier (USUBJID) variable must be unique for each subject across all trials in the submission.
_ALL_
USUBJID
X
SDTM0673
OpenCDISC
SD1001
The value of subject identifier for the study (SUBJID) variable must be unique for each subject with the study.
DM
SUBJID
X
SDTM0801
JanusFR
IR4500
Identifies non-demographics domain subjects (USUBJID) not found in the demographics domain.
[_ALL_-DM][DM]
STUDYID+USUBJID
X
SDTM0801
WebSDM
IR4500
(IR5500)
Identifies non-demographics domain subjects (USUBJID) not found in the demographics domain.
[_ALL_-DM][DM]
STUDYID+USUBJID
X
X
SDTM0802
Janus
IR4505
Identifies demographics subjects where no record for the subject is found in the disposition domain.
[DM][DS]
STUDYID+USUBJID
X
SDTM0802
WebSDM
IR4505
(IR5505)
Identifies demographics subjects where no record for the subject is found in the disposition domain.
[DM][DS]
STUDYID+USUBJID
X
X
SDTM0803
Janus
IR4506
Identifies demographics subjects where no record for the subject is found in the exposure domain.
[DM][EX]
STUDYID+USUBJID
X
SDTM0803
WebSDM
IR4506
(IR5506)
Identifies demographics subjects where no record for the subject is found in the exposure domain.
[DM][EX]
STUDYID+USUBJID
X
X
SDTM0804
Janus
IR4501
Identifies Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combinations not found in the SV domain.
[_ALL_-SV][SV]
USUBJID+VISITNUM+VISIT
X
SDTM0804
WebSDM
IR4501
(IR5501)
Identifies Unique Subject Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM) combinations not found in the SV domain.
[_ALL_-SV][SV]
USUBJID+VISITNUM+VISIT
X
X
SDTM0805
Janus
IR4502
Identifies records where the value for ARM code (ARMCD) is not found in the TA domain, excluding 'SCRNFAIL'.
[DM][TA]
ARMCD
X
SDTM0805
WebSDM
IR4502
(IR5502)
Identifies records where the value for ARM code (ARMCD) is not found in the TA domain, excluding 'SCRNFAIL'.
[DM][TA]
ARMCD
X
X
SDTM0806
JanusFR
IR4507
Identifies demographics treatment arms (Description of Arm (ARM) + Arm Code (ARMCD) combination) not found in the TA domain, excluding 'Screen Failure', 'SCRNFAIL'.
[DM][TA]
ARM+ARMCD
X
SDTM0806
WebSDM
IR4507
(IR5507)
Identifies demographics treatment arms (Description of Arm (ARM) + Arm Code (ARMCD) combination) not found in the TA domain, excluding 'Screen Failure', 'SCRNFAIL'.
[DM][TA]
ARM+ARMCD
X
X
SDTM0807
JanusFR
SAS0039
TA domain is not provided and Planned Arm Code (ARMCD) is null for all rows in the demographics domain.
DM
ARMCD
X
SDTM0807
SAS
SAS0039
TA domain is not provided and Planned Arm Code (ARMCD) is null for all rows in the demographics domain.
DM
ARMCD
X
SDTM0808
WebSDM
IR4170
(IR5170)
Identifies records that violate the condition [Visit Name (VISIT) must be the same for a given value of Visit Number (VISITNUM)].
SV
[VISIT] [VISITNUM]
X
X
SDTM0809
WebSDM
IR4171
(IR5171)
Identifies records that violate the condition [Visit Number (VISITNUM) must be the same for a given value of Visit Name (VISIT)].
SV
[VISITNUM] [VISIT]
X
X
SDTM0811
Janus
IR4503
Identifies records where the value for Subject Element Code (ETCD) is not found in the TE domain.
[TA][TE]
ETCD
X
SDTM0811
Janus
IR4503
Identifies records where the value for Subject Element Code (ETCD) is not found in the TE domain.
[SE][TE]
ETCD
X
SDTM0811
WebSDM
IR4503
Identifies records where the value for Subject Element Code (ETCD) is not found in the TE domain.
[TA][TE]
ETCD
X
X
SDTM0811
WebSDM
IR4503
Identifies records where the value for Subject Element Code (ETCD) is not found in the TE domain.
[SE][TE]
ETCD
X
X
SDTM0812
WebSDM
IR5516
Identifies records in exposure that should not be present since the subject has Arm Code (ARMCD)='NOTASSGN'.
[EX][DM]
USUBJID
X
SDTM0821
JanusFR
IR4504
Identifies records where the value for Inclusion/Exclusion Criterion Short Name (IETESTCD) is not found in the TI domain.
[IE][TI]
IETESTCD
X
SDTM0821
WebSDM
IR4504
Identifies records where the value for Inclusion/Exclusion Criterion Short Name (IETESTCD) is not found in the TI domain.
[IE][TI]
IETESTCD
X
X
SDTM0822
Janus
SAS0023
Identifies records where the value for Inclusion/Exclusion Category (IECAT) in the IE domain does not exist in the TI domain if the TI domain was supplied.
[IE][TI]
IECAT
X
SDTM0822
SAS
SAS0023
Identifies records where the value for Inclusion/Exclusion Category (IECAT) in the IE domain does not exist in the TI domain if the TI domain was supplied.
[IE][TI]
IECAT
SDTM0823
OpenCDISC
SD1016
The combination of Inclusion/Exclusion Criterion Short Name (IETESTCD), Criterion (IETEST), and Category (IECAT) values must match entries in the Trial Inclusion/Exclusion Criteria (TI) data set.
[IE][TI]
IETESTCD+ IETEST+ IECAT
X
SDTM0831
JanusFR
SAS0020
The Study Identifier (STUDYID) in the TA domain does not match STUDYID in the DM domain.
[TA][DM]
STUDYID
X
SDTM0831
SAS
SAS0020
The study identifier (STUDYID) in the TA domain does not match STUDYID in the DM domain.
[TA][DM]
STUDYID
SDTM0836
JanusFR
SAS0021
The study identifier (STUDYID) in the TV domain does not match STUDYID in the DM domain.
[TV][DM]
STUDYID
X
SDTM0836
SAS
SAS0021
The study identifier (STUDYID) in the TV domain does not match STUDYID in the DM domain.
[TV][DM]
STUDYID
SDTM0841
Janus
SAS0026
Identifies records where a value for VISITNUM in the SV domain is not found in the TV domain, limited to records where both the SV and TV domains exist and the Description of Unplanned Visit (SVUPDES) is null.
[SV][TV]
VISITNUM
X
SDTM0841
OpenCDISC
SD1017
Identifies records where a value for VISITNUM in the SV domain is not found in the TV domain, limited to records where both the SV and TV domains exist and the Description of Unplanned Visit (SVUPDES) is null.
[SV][TV]
VISITNUM
X
SDTM0842
OpenCDISC
SD1012
The combination of Element Code (ETCD) and Description of Element (ELEMENT) values must match entries in the Trial Elements (TE) data set, except for unplanned Element (ETCD = 'UNPLAN').
[SE+TA][TE]
ETCD+ ELEMENT
X
SDTM0843
OpenCDISC
SD1013
When subjects experience for a particular period of time is represented as an unplanned element, where Element Code (ETCD) is equal to 'UNPLAN', then Planned Order of Elements within Arm (TAETORD) should be null.
SE
[ETCD] [TAETORD]
X
SDTM0844
OpenCDISC
SD1014
Order of Element within Arm (TAETORD) values must match the entries in the Trial Arms (TA) data set.
[_ALL_-TA][TA]
TAETORD
X
SDTM0845
OpenCDISC
SD1015
Epoch (EPOCH) values must match the entries in the Trial Arms (TA) data set.
[_ALL_-TA][TA]
EPOCH
X
SDTM0846
OpenCDISC
SD1018
For planned visits, where Description of Unplanned Visit (SVUPDES) is null, the combination of Visit Number (VISITNUM), Visit Name (VISIT), and Planned Study Day of Visit (VISITDY) values must match the entries in the Trial Visits (TV) data set.
[SV][TV]
VISITNUM+ VISIT+ VISITDY
X
SDTM0851
JanusFR
IR4508
Identifies comments (CO) domain reference to an unknown related domain.
CO
RDOMAIN
X
SDTM0851
WebSDM
IR4508
(IR5508)
Identifies comments (CO) domain reference to an unknown related domain.
CO
RDOMAIN
X
X
SDTM0860
WebSDM
R5132
Identifies records where value for [Relationship Type (RELTYPE)] is not found in Codelist [CARDINALITY], limited to records where [RELTYPE is not null].
RELREC
RELTYPE
X
SDTM0861
Janus
IR4509
Identifies Related Records (RELREC) domain reference to an unknown related domain.
RELREC
RDOMAIN
X
SDTM0861
WebSDM
IR4509
(IR5509)
Identifies Related Records (RELREC) domain reference to an unknown related domain.
RELREC
RDOMAIN
X
X
SDTM0862
JanusFR
IR4510
Identifies Supplemental Qualifiers (SUPPQUAL) domain reference to an unknown related domain.
SUPP**
RDOMAIN
X
SDTM0862
WebSDM
IR4510
(IR5510)
Identifies Supplemental Qualifiers (SUPPQUAL) domain reference to an unknown related domain.
SUPP**
RDOMAIN
X
X
SDTM0863
Janus
IR4511
Identifies Related Records (RELREC) domain reference to a key variable that is not defined in the target domain.
RELREC
IDVAR
X
SDTM0863
WebSDM
IR4511
(IR5511)
Identifies Related Records (RELREC) domain reference to a key variable that is not defined in the target domain.
RELREC
IDVAR
X
X
SDTM0864
JanusFR
IR4512
Identifies Supplemental Qualifiers (SUPPQUAL) domain reference to a key variable that is not defined in the target domain.
SUPP**
IDVAR
X
SDTM0864
WebSDM
IR4512
(IR5512)
Identifies Supplemental Qualifiers (SUPPQUAL) domain reference to a key variable that is not defined in the target domain.
SUPP**
IDVAR
X
X
SDTM0865
Janus
IR4513
Identifies Related Records (RELREC) domain reference to a record that does not exist in the target domain.
RELREC
IDVAR
X
SDTM0865
WebSDM
IR4513
(IR5513)
Identifies Related Records (RELREC) domain reference to a record that does not exist in the target domain.
RELREC
IDVAR
X
X
SDTM0866
JanusFR
IR4514
Identifies Supplemental Qualifiers (SUPPQUAL) domain reference to a record that does not exist in the target domain.
SUPP**
IDVAR
X
SDTM0866
WebSDM
IR4514
(IR5514)
Identifies Supplemental Qualifiers (SUPPQUAL) domain reference to a record that does not exist in the target domain.
SUPP**
IDVAR
X
X
SDTM0871
Janus
SAS0024
Identifies comments (CO) domain reference to a record that does not exist in the target domain.
CO
IDVAR
X
SDTM0871
OpenCDISC
SD1007
Identifies comments (CO) domain reference to a record that does not exist in the target domain.
CO
IDVAR
X
SDTM0872
OpenCDISC
SD1006
When comments are related to a specific parent record or group of parent records in a domain, then the value of Identifying Variable (IDVAR) must reference a key variable name in the parent domain.
CO
IDVAR
X