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|
|
Identifies domain table
that has zero rows and, therefore, contains no data.
|
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|
|
|
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|
|
Identifies domain table
that has zero rows and, therefore, contains no data.
|
|
|
|
|
|
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|
|
A load of data into
Janus requires that the DM, DS, and EX domains be submitted for each
study to be loaded.
|
|
|
|
|
|
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|
|
A load of data into
JANUS requires that the DM, DS, and EX domains be submitted for each
study to be loaded.
|
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|
|
|
|
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|
|
WebSDM and the SDTM
model require only the DM domain be present.
|
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|
Source metadata includes
domain data set not found in reference metadata.
|
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|
|
Custom domain data set
does not conform to specification naming guidelines.
|
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|
|
Source data library
contains domain data not found in study metadata.
|
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|
|
Identifies a column
that was described in the domain description, but not included in
the SAS data set for that domain.
|
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|
|
Identifies a column
that was described in the domain description, but not included in
the SAS data set for that domain.
|
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|
|
Identifies a column
listed in the domain description as required (Req), but not included
in the SAS data set for that domain.
|
|
|
|
|
|
|
|
|
Identifies a column
listed in the domain description as required (Req), but not included
in the SAS data set for that domain.
|
|
|
|
|
|
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|
|
Identifies a column
listed in the domain description as expected (Exp), but not included
in the SAS data set for that domain.
|
|
|
|
|
|
|
|
|
Identifies a column
listed in the domain description as expected (Exp), but not included
in the SAS data set for that domain.
|
|
|
|
|
|
|
|
|
Identifies a column
listed in the domain description as permissible (Perm), but not included
in the SAS data set for that domain.
|
|
|
|
|
|
|
|
|
Identifies a column
that appears in the SAS data set, but is not listed in the domain
description.
|
|
|
|
|
|
|
|
|
Identifies a column
that appears in the SAS data set, but is not listed in the domain
description.
|
|
|
|
|
|
|
|
|
Identifies a variable
that is present in the SAS data set, but not present in the (study-specific)
description file.
|
|
|
|
|
|
|
|
|
Identifies a domain
that appears to contain supplemental qualifier data, but does not
contain the unique subject identifier (USUBJID).
|
|
|
|
|
|
|
|
|
Identifies a domain
that appears to contain supplemental qualifier data, but does not
contain the unique subject identifier (USUBJID).
|
|
|
|
|
|
|
|
|
Identifies a variable
where data type in (study-specific) description is not consistent
with data type implicit in SAS data set.
|
|
|
|
|
|
|
|
|
Identifies a variable
where data type in (study-specific) description is not consistent
with data type implicit in SAS data set.
|
|
|
|
|
|
|
|
|
Column order does not
match standard.
|
|
|
|
|
|
|
|
|
Column length < length
defined in standard.
|
|
|
|
|
|
|
|
|
Column length > length
defined in standard.
|
|
|
|
|
|
|
|
|
Column label inconsistent
with label defined in standard.
|
|
|
|
|
|
|
|
|
Column format found,
but column not subject to controlled terminology.
|
|
|
|
|
|
|
|
|
Column format found,
but format name mismatch with standard controlled terminology name.
|
|
|
|
|
|
|
|
|
Identifies a variable
that has been deprecated according to the CDISC SDTM standard.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
Identifies a domain
that is referenced in a description file, but for which there is no
source data.
|
|
|
|
|
|
|
|
|
Identifies a domain
whose source data failed to load.
|
|
|
|
|
|
|
|
|
Identifies a variable
that uses an unsupported event dictionary.
|
|
|
|
|
|
|
|
|
Identifies a variable
whose referenced codelist is not properly defined in the associated
define.xml file.
|
|
|
|
|
|
|
|
|
Identifies a domain
for which metadata has not been provided.
|
|
|
|
|
|
|
|
|
Identifies values that
do not conform to the ISO 8601 standard for datetimes.
|
|
**DTC+**STDTC+**ENDTC+BRTHDTC+RFSTDTC+RFENDTC
|
|
|
|
|
|
|
Identifies values that
do not conform to the ISO 8601 standard for datetimes.
|
|
**DTC+**STDTC+**ENDTC+BRTHDTC+RFSTDTC+RFENDTC
|
|
|
|
|
|
|
Identifies values that
do not conform to the ISO 8601 standard for durations.
|
|
|
|
|
|
|
|
|
Identifies values that
do not conform to the ISO 8601 standard for durations.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [LENGTH(Name of Measurement, Test, or Examination
(**TEST)) less than or equal to 40 characters].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [LENGTH(Name of Measurement, Test, or Examination
(**TEST)) less than or equal to 40 characters].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
Qualifier variable label
(QLABEL) length > 40.
|
|
|
|
|
|
|
|
|
Qualifier variable name
(QNAM) length > 8, starts with a number, or contains special characters.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [LENGTH(Trial Summary Parameter (**PARM)) less
than or equal to 40 characters].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [LENGTH(Trial Summary Parameter (**PARM)) less
than or equal to 40 characters].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
The value of planned
arm code (ARMCD) must not be more than 20 characters in length.
|
|
|
|
|
|
|
|
|
The value of the element
code (ETCD) must not be no more than 8 characters in length.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
Start date/time of adverse
event (AESTDTC) must be less than or equal to the start date/time
of the latest disposition event (DSSTDTC).
|
|
|
|
|
|
|
|
|
Date/time of collection
(DTC) must be less than or equal to the start date/time of the latest
disposition event (DSSTDTC).
|
|
|
|
|
|
|
|
|
End of date/time of
treatment (EXENDTC) must be less than or equal to the start date/time
of the latest disposition event (DSSTDTC).
|
|
|
|
|
|
|
|
|
Identifies a null (empty)
value found in a column where (Standard) Core attribute is Req.
|
|
|
|
|
|
|
|
|
Identifies a null (empty)
value found in a column where (Standard) Core attribute is Req.
|
|
|
|
|
|
|
|
|
Identifies a null (empty)
value found in a column where (Standard) Core attribute is Exp.
|
|
|
|
|
|
|
|
|
Character column value
is not correctly uppercased per specification.
|
|
|
|
|
|
|
|
|
Character column value
contains the numeric missing '.' or any special missing value like
'.N'.
|
|
|
|
|
|
|
|
|
Column value is not
left-justified.
|
|
|
|
|
|
|
|
|
Identifies records where
the value in the Domain Abbreviation column (DOMAIN) does not match
the name of Domain.
|
|
|
|
|
|
|
|
|
Identifies records where
the value in the Domain Abbreviation column (DOMAIN) does not match
the name of Domain.
|
|
|
|
|
|
|
|
|
Identifies records where
the value for Visit Number (VISITNUM) is formatted to more than three
decimal places.
|
|
|
|
|
|
|
|
|
Identifies records where
the value for Visit Number (VISITNUM) is formatted to more than 3
decimal places.
|
|
|
|
|
|
|
|
|
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'.
|
|
|
|
|
|
|
|
|
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'.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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'].
|
|
|
|
|
|
|
|
|
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'].
|
|
|
|
|
|
|
|
|
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'].
|
|
|
|
|
|
|
|
|
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'].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Evaluation Interval (**EVLINT) greater than
or equal to 0], limited to records where **EVLINT is not null.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Evaluation Interval (**EVLINT) greater than
or equal to 0], limited to records where **EVLINT is not null.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Status (**STAT) equals NOT DONE ], limited
to records where **STAT is not null.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Status (**STAT) equals NOT DONE ], limited
to records where **STAT is not null.
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [reason not done (**REASND) is null], limited
to records where [status (**STST) is null].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Duration (**DUR) greater than or equal to 0],
limited to records where **DUR is not null.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Duration (**DUR) greater than or equal to 0],
limited to records where **DUR is not null.
|
|
|
|
|
|
|
|
|
Identifies records where
values are not found in the study-specific codelist attached to a
variable.
|
|
|
|
|
|
|
|
|
Identifies records where
values are not found in the study-specific codelist attached to a
variable.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Study Day of Visit/Collection/Exam (**DY) does
not equal 0].
|
|
**DY+**STDY+**ENDY+VISITDY
|
|
|
|
|
|
|
Identifies records that
violate the condition [Study Day of Visit/Collection/Exam (**DY) does
not equal 0].
|
|
**DY+**STDY+**ENDY+VISITDY
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
Identifies records with
the condition [subcategory (**SCAT) is not null when category of related
records (**CAT) is null].
|
|
|
|
|
|
|
|
|
Identifies records with
the condition [subcategory (**SCAT) is not null when category of related
records (**CAT) is null].
|
|
|
|
|
|
|
|
|
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'].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [if non-null result or finding in original units
is provided, then status must be null].
|
|
|
|
|
|
|
|
|
When age units (AGEU)
are not null, then age (AGE) should be provided.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
For unplanned visits
where the description of the unplanned visit (SVUPDES) is populated,
the planned study day of visit (VISITDY) should be null.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Toxicity Grade (**TOXGR) is a valid number],
limited to records where **TOXGR is not null.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [toxicity grade (**TOXGR) is a valid number],
limited to records where **TOXGR is not null.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Toxicity Grade (**TOXGR) is a valid number],
limited to records where **TOXGR is not null.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Toxicity Grade (**TOXGR) is a valid number],
limited to records where **TOXGR is not null.
|
|
|
|
|
|
|
|
|
Value for column defined
as a data set key is null.
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Occurrence (**OCCUR) in ( Y , N )], limited
to records where **OCCUR is not null.
|
CLASS:EVENTS+CLASS:INTERVENTIONS
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Occurrence (**OCCUR) in ( Y , N )], limited
to records where **OCCUR is not null.
|
CLASS:EVENTS+CLASS:INTERVENTIONS
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
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'.
|
|
|
|
|
|
|
|
|
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'.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Dose (**DOSE) greater than or equal to 0],
limited to records where **DOSE is not null.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Dose (**DOSE) greater than or equal to 0],
limited to records where **DOSE is not null.
|
|
|
|
|
|
|
|
|
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'.
|
|
|
|
|
|
|
|
|
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'.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Related Domain (RDOMAIN) is not null].
|
|
|
|
|
|
|
|
|
Value for Related Domain
(RDOMAIN) is inconsistent with data set name.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Baseline Flag (**BLFL) either 'Y' or null].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Baseline Flag (**BLFL) either 'Y' or null].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Derived Flag (**DRVFL) either 'Y' or null].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Derived Flag (**DRVFL) either 'Y' or null].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Fasting Status (**FAST) in ( Y , N , U )],
limited to records where **FAST is not null.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Fasting Status (**FAST) in ( Y , N , U )],
limited to records where **FAST is not null.
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Original units (**ORRESU) is null], limited
to records where [Result or Finding in Original Units (**ORRES) is
null].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Original units (**ORRESU) is null], limited
to records where [Result or Finding in Original Units (**ORRES) is
null].
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Standard Units (**STRESU) is null], limited
to records where [Result or Finding in Standard Format (**STRESC)
is null].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Standard Units (**STRESU) is null], limited
to records where [Result or Finding in Standard Format (**STRESC)
is null].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [standard units (**STRESU) is null], limited
to records where [result or finding in standard format (**STRESC)
is null].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [if non-null occurrence (**OCCUR) is provided,
then pre-specified (**PRESP) must equal 'Y'].
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [treatment vehicle (**TRTV) is not null], limited
to records where [treatment vehicle amount (**VAMT) is not null].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
Identifies a sponsor-derived
flag variable for 'treatment emergent AE' where the derivation cannot
be executed.
|
|
|
|
|
|
|
|
|
Identifies a sponsor-derived
flag variable for 'clinically significant lab' where the derivation
cannot be executed.
|
|
|
|
|
|
|
|
|
Identifies a sponsor-derived
flag variable for 'clinically significant vital sign' where the derivation
cannot be executed.
|
|
|
|
|
|
|
|
|
Identifies user-defined
codelist values that are not found in the corresponding SDTM codelist.
|
|
|
|
|
|
|
|
|
Identifies records where
the lookup value for a coded field (such as **DECOD, **BODSYS or **LOINC)
could not be found in the associated dictionary.
|
|
|
|
|
|
|
|
|
Identifies records where
the value for the preferred term could not be found in the MedDRA
dictionary.
|
|
|
|
|
|
|
|
|
Identifies records where
the value for the preferred term could not be found in the MedDRA
dictionary.
|
|
|
|
|
|
|
|
|
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'.
|
|
|
|
|
|
|
|
|
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'.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [Serious Event (AESER)] is not found in codelist [YESNO].
|
|
|
|
|
|
|
|
|
Identifies records where
value for [Serious Event (AESER)] is not found in Codelist [YESNO].
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [Results in Death (AESDTH)] is not found in Codelist [YESNO],
limited to records where AESDTH is not null.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [Results in Death (AESDTH)] is not found in Codelist [YESNO],
limited to records where AESDTH is not null.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [Requires or Prolongs Hospitalization (AESHOSP)] is not
found in Codelist [YESNO], limited to records where AESHOSP is not
null.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [Requires or Prolongs Hospitalization (AESHOSP)] is not
found in Codelist [YESNO], limited to records where AESHOSP is not
null.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [Is Life Threatening (AESLIFE)] is not found in Codelist
[YESNO], limited to records where AESLIFE is not null.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [Is Life Threatening (AESLIFE)] is not found in Codelist
[YESNO], limited to records where AESLIFE is not null.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [Involves Cancer (AESCAN)] is not found in Codelist [YESNO],
limited to records where AESCAN is not null.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [Involves Cancer (AESCAN)] is not found in Codelist [YESNO],
limited to records where AESCAN is not null.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [Occurred with Overdose (AESOD)] is not found in Codelist
[YESNO], limited to records where AESOD is not null.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [Occurred with Overdose (AESOD)] is not found in Codelist
[YESNO], limited to records where AESOD is not null.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Results in Death (AESDTH)= Y ], limited to
records where [Outcome of Adverse Event (AEOUT)='FATAL'].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Results in Death (AESDTH)= Y ], limited to
records where [Outcome of Adverse Event (AEOUT)='FATAL'].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Outcome of Adverse Event (AEOUT)='FATAL'],
limited to records where [Results in Death (AESDTH)='Y'].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Outcome of Adverse Event (AEOUT)='FATAL'],
limited to records where [Results in Death (AESDTH)='Y'].
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [outcome of adverse event (AEOUT)] is not found in codelist
[OUT], limited to records where AEOUT is not null.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [severity or intensity (AESEV)] is not found in codelist
[AESEV], limited to records where AESEV is not null.
|
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in AGESPAN (C66780) CDISC controlled
terminology codelist.
|
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in AGEU (C66781) CDISC terminology codelist.
|
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in drug accountability test name (C66731)
CDISC controlled terminology codelist.
|
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in drug accountability test code (C66732)
CDISC controlled terminology codelist.
|
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in 'Domain Abbreviation' (C66734) CDISC
controlled terminology codelist.
|
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in evaluator (C78735) CDISC controlled
terminology codelist.
|
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in evaluator (C78735) CDISC controlled
terminology codelist.
|
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in MARISTAT (C76348) CDISC controlled
terminology codelist.
|
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in 'Reference Range Indicator' (C78736)
CDISC controlled terminology codelist.
|
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in ROUTE (C66729) CDISC controlled terminology
codelist.
|
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in SEXPOP (C66732) CDISC controlled
terminology codelist.
|
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in AGESPAN (C66780) CDISC controlled
terminology codelist.
|
CLASS:FINDINGS+CLASS:EVENTS
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in TBLIND (C66735) CDISC controlled
terminology codelist.
|
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in TCNTRL (C66785) CDISC controlled
terminology codelist.
|
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in TDIGRP (C66787) CDISC controlled
terminology codelist.
|
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in TINDTP (C66736) CDISC controlled
terminology codelist.
|
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in TPHASE (C66737) CDISC controlled
terminology codelist.
|
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in Trial Summary Parameter Test Name
(C67152) CDISC controlled terminology codelist.
|
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in Trial Summary Parameter Test Code
(C66738) CDISC controlled terminology codelist.
|
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in TTYPE (C66739) CDISC controlled terminology
codelist.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Pre-specified (**PRESP) is either 'Y' or null].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [route of administration (**ROUTE) is in codelist
ROUTE or is null].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [position of subject during observation (**POS)
is in codelist POSITION or is null].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [start relative to reference time point (**STRTPT)
is in codelist STRTPT or is null].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [end relative to reference time point (**ENRTPT)
is in codelist ENRTPT or is null].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [dose units (**DOSU) is in codelist UNIT or
is null].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Original Units (**ORRESU) is in codelist UNIT
or is null].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Standard Units (**STRESU) is in codelist UNIT
or is null].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [location used for the measurement (**LOC) is
in codelist LOC or is null].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [dosing frequency per interval (**DOSFRQ) is
in codelist FREQ or is null].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [if arm code (ARMCD)='NOTASSGN' then description
of arm (ARM) must equal 'Not Assigned', and vice versa].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [If Arm Code (ARMCD)='SCRNFAIL' then Description
of Arm (ARM) must equal 'Screen Failure', and vice versa].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [If Arm Code (ARMCD)='SCRNFAIL' then Description
of Arm (ARM) must equal 'Screen Failure', and vice versa].
|
|
|
|
|
|
|
|
|
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'.
|
|
|
|
|
|
|
|
|
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'.
|
|
|
|
|
|
|
|
|
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'.
|
|
|
|
|
|
|
|
|
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'.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [SEX] is not found in codelist [SEX].
|
|
|
|
|
|
|
|
|
Identifies records where
value for [SEX] is not found in codelist [SEX].
|
|
|
|
|
|
|
|
|
Identifies records where
value for [COUNTRY] is not found in codelist [COUNTRY].
|
|
|
|
|
|
|
|
|
Identifies records where
value for [COUNTRY] is not found in codelist [COUNTRY].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [age (AGE) greater than or equal to 0], limited
to records where AGE is not null.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [age (AGE) greater than or equal to 0], limited
to records where AGE is not null.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [age units (AGEU) is not null], limited to records
where AGE is not null.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [age units (AGEU) is not null], limited to records
where AGE is not null.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [age units (AGEU)] is not found in codelist [AGEUNITS2],
limited to records where AGEU is not null.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [age units (AGEU)] is not found in codelist [AGEUNITS2],
limited to records where AGEU is not null.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [ethnicity (ETHNIC)] is not found in codelist [ETHNIC],
limited to records where ETHNIC is not null.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [race] is not found in codelist [RACE], limited to records
where [race is not null].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [category for disposition event (DSCAT) = 'DISPOSITION
EVENT'], limited to records where [epoch (EPOCH) is not null].
|
|
|
|
|
|
|
|
|
Identifies records where
value for [category for disposition event (DSCAT)] is not found in
codelist [DSCAT].
|
|
|
|
|
|
|
|
|
Identifies records where
value for [subject characteristic short name (SCTESTCD)] is not found
in codelist [SCCD].
|
|
|
|
|
|
|
|
|
Identifies records where
value for [dose form (CMDOSFRM)] is not found in codelist [FRM], limited
to records where [CMDOSFRM is not null].
|
|
|
|
|
|
|
|
|
Identifies records where
value for [ECG Test or Examination Name (EGTEST)] is not found in
Codelist [EGTEST].
|
|
|
|
|
|
|
|
|
Identifies records where
value for [ECG test or examination short name (EGTESTCD)] is not found
in codelist [EGTESTCD].
|
|
|
|
|
|
|
|
|
Identifies records where
value for [method of ECG rest (EGMETHOD)] is not found in codelist
[EGMETHOD], limited to records where [EGMETHOD is not null].
|
|
|
|
|
|
|
|
|
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].
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [dose form (EXDOSFRM)] is not found in codelist [FRM], limited
to records where [EXDOSFRM is not null].
|
|
|
|
|
|
|
|
|
Identifies records where
value for [treatment vehicle amount units (EXVAMTU)] is not found
in codelist [UNIT], limited to records where [EXVAMTU is not null].
|
|
|
|
|
|
|
|
|
Identifies records where
value for [Inclusion or Exclusion Category (IECAT)] is not found in
codelist [INCEX], limited to records where IECAT is not null.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [Inclusion or Exclusion Category (IECAT)] is not found in
codelist [INCEX], limited to records where IECAT is not null.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [I/E Criterion Original Result (IEORRES) = I/E
Criterion Original Result in Std Format (IESTRESC)].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [I/E Criterion Original Result (IEORRES) = I/E
Criterion Original Result in Std Format (IESTRESC)].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Description of Unplanned Element (SEUPDES)
is not null], limited to records where Subject Element Code (ETCD)
='UNPLAN'.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Description of Unplanned Element (SEUPDES)
is not null], limited to records where Subject Element Code (ETCD)
='UNPLAN'.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [If Arm Code (ARMCD)='SCRNFAIL' then Description
of Arm (ARM) must equal 'Screen Failure', and vice versa].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [If Arm Code (ARMCD)='SCRNFAIL' then Description
of Arm (ARM) must equal 'Screen Failure', and vice versa].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Rule for End of Element (TEENRL) is not null
or Planned Duration of Element (TEDUR) is not null].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Rule for End of Element (TEENRL) is not null
or Planned Duration of Element (TEDUR) is not null].
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [lab test or examination name (LBTEST)] is not found in
codelist [LBTEST].
|
|
|
|
|
|
|
|
|
Identifies records where
value for [lab test or examination code (LBTESTCD)] is not found in
codelist [LBTESTCD].
|
|
|
|
|
|
|
|
|
Identifies records where
value for [original units (VSORRESU)] is not found in codelist [VSRESU],
limited to records where [VSORRESU is not null].
|
|
|
|
|
|
|
|
|
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'].
|
|
|
|
|
|
|
|
|
Identifies records where
value for [standard units (VSSTRESU)] is not found in codelist [VSRESU],
limited to records where [VSSTRESU is not null].
|
|
|
|
|
|
|
|
|
Identifies records where
value for [vital signs test name (VSTEST)] is not found in codelist
[VSTEST].
|
|
|
|
|
|
|
|
|
Identifies records where
value for [vital signs test short name (VSTESTCD)] is not found in
codelist [VSTESTCD].
|
|
|
|
|
|
|
|
|
Variable values should
be populated with terms found in completion/reason for non-completion
(C66727) CDISC controlled terminology codelist.
|
|
|
|
|
|
|
|
|
Domain not sorted by
keys as defined in standard.
|
|
|
|
|
|
|
|
|
Records are not unique
by the expected keys
|
|
|
|
|
|
|
|
|
Identifies records where
non-unique values for Sequence Number variable (**SEQ) exist within
a subject.
|
|
|
|
|
|
|
|
|
Identifies records where
non-unique values for Sequence Number variable (**SEQ) exist within
a subject.
|
|
|
|
|
|
|
|
|
Sequence Number (**SEQ)
values are not consecutively incremented beginning at 1 for each USUBJID.
|
|
|
|
|
|
|
|
|
Sequence Number (**SEQ)
values are not consecutively incremented beginning at 1 for each USUBJID.
|
|
|
|
|
|
|
|
|
Report any variable
for the domain that contains all missing or null values.
|
|
|
|
|
|
|
|
|
Identify any column
defined as numeric in the standard that contains non-numeric values.
|
|
|
|
|
|
|
|
|
Identify any columns
defined as numeric in the standard that contains non-numeric values.
|
|
|
|
|
|
|
|
|
Site Study Identifier
(SITEID) is null for all records.
|
|
|
|
|
|
|
|
|
Site study identifier
(SITEID) is null for all records.
|
|
|
|
|
|
|
|
|
Identifies subjects
where there are no records with a value of 'Y' in the baseline flag
variable (**BLFL), excluding Arm Code (ARMCD)='SCRNFAIL'.
|
|
|
|
|
|
|
|
|
Inconsistency between
test (**TEST) and test code (**TESTCD).
|
|
|
|
|
|
|
|
|
Identifies Test Code
(**TESTCD) values where Standard Units (**STRESU) value is not consistent
across all records.
|
|
|
|
|
|
|
|
|
Identifies Short Name
of Measurement, Test, or Examination (**TESTCD) values where Standard
Units (**STRESU) value is not consistent across all records.
|
|
|
|
|
|
|
|
|
Identifies Short Name
of Measurement, Test, or Examination (**TESTCD) values where Standard
Units (**STRESU) value is not consistent across all records.
|
|
|
|
|
|
|
|
|
Identifies records where
values for Unique Subject ID (USUBJID) are not unique, limited to
records where USUBJID is not null.
|
|
|
|
|
|
|
|
|
Identifies records where
values for Unique Subject ID (USUBJID) are not unique, limited to
records where USUBJID is not null.
|
|
|
|
|
|
|
|
|
Inconsistency between
Description of Arm (ARM) and Arm Code (ARMCD) values across all records.
|
|
|
|
|
|
|
|
|
AGE precision inconsistent
across records.
|
|
|
|
|
|
|
|
|
The current version
of JANUS requires that the STUDYID column have the same value for
all records within a study.
|
|
|
|
|
|
|
|
|
The current version
of JANUS requires that the STUDYID column have the same value for
all records within a study.
|
|
|
|
|
|
|
|
|
STUDYID should have
the same value for all records within a study.
|
|
|
|
|
|
|
|
|
Study identifier (STUDYID)
values must match the STUDYID in demographics (DM) domain.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
Identifies qualifier
variable name (QNAM) where variable label value (Qualifier Variable
Label QLABEL) is not consistent across all records.
|
|
|
|
|
|
|
|
|
Inconsistency between
Trial Summary Parameter (TSPARM) and Trial Summary Parameter Short
Name (TSPARMCD).
|
|
|
|
|
|
|
|
|
The value of unique
subject identifier (USUBJID) variable must be unique for each subject
across all trials in the submission.
|
|
|
|
|
|
|
|
|
The value of subject
identifier for the study (SUBJID) variable must be unique for each
subject with the study.
|
|
|
|
|
|
|
|
|
Identifies non-demographics
domain subjects (USUBJID) not found in the demographics domain.
|
|
|
|
|
|
|
|
|
Identifies non-demographics
domain subjects (USUBJID) not found in the demographics domain.
|
|
|
|
|
|
|
|
|
Identifies demographics
subjects where no record for the subject is found in the disposition
domain.
|
|
|
|
|
|
|
|
|
Identifies demographics
subjects where no record for the subject is found in the disposition
domain.
|
|
|
|
|
|
|
|
|
Identifies demographics
subjects where no record for the subject is found in the exposure
domain.
|
|
|
|
|
|
|
|
|
Identifies demographics
subjects where no record for the subject is found in the exposure
domain.
|
|
|
|
|
|
|
|
|
Identifies Unique Subject
Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM)
combinations not found in the SV domain.
|
|
|
|
|
|
|
|
|
Identifies Unique Subject
Identifier (USUBJID) + Visit Name (VISIT) + Visit Number (VISITNUM)
combinations not found in the SV domain.
|
|
|
|
|
|
|
|
|
Identifies records where
the value for ARM code (ARMCD) is not found in the TA domain, excluding
'SCRNFAIL'.
|
|
|
|
|
|
|
|
|
Identifies records where
the value for ARM code (ARMCD) is not found in the TA domain, excluding
'SCRNFAIL'.
|
|
|
|
|
|
|
|
|
Identifies demographics
treatment arms (Description of Arm (ARM) + Arm Code (ARMCD) combination)
not found in the TA domain, excluding 'Screen Failure', 'SCRNFAIL'.
|
|
|
|
|
|
|
|
|
Identifies demographics
treatment arms (Description of Arm (ARM) + Arm Code (ARMCD) combination)
not found in the TA domain, excluding 'Screen Failure', 'SCRNFAIL'.
|
|
|
|
|
|
|
|
|
TA domain is not provided
and Planned Arm Code (ARMCD) is null for all rows in the demographics
domain.
|
|
|
|
|
|
|
|
|
TA domain is not provided
and Planned Arm Code (ARMCD) is null for all rows in the demographics
domain.
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Visit Name (VISIT) must be the same for a given
value of Visit Number (VISITNUM)].
|
|
|
|
|
|
|
|
|
Identifies records that
violate the condition [Visit Number (VISITNUM) must be the same for
a given value of Visit Name (VISIT)].
|
|
|
|
|
|
|
|
|
Identifies records where
the value for Subject Element Code (ETCD) is not found in the TE domain.
|
|
|
|
|
|
|
|
|
Identifies records where
the value for Subject Element Code (ETCD) is not found in the TE domain.
|
|
|
|
|
|
|
|
|
Identifies records where
the value for Subject Element Code (ETCD) is not found in the TE domain.
|
|
|
|
|
|
|
|
|
Identifies records where
the value for Subject Element Code (ETCD) is not found in the TE domain.
|
|
|
|
|
|
|
|
|
Identifies records in
exposure that should not be present since the subject has Arm Code
(ARMCD)='NOTASSGN'.
|
|
|
|
|
|
|
|
|
Identifies records where
the value for Inclusion/Exclusion Criterion Short Name (IETESTCD)
is not found in the TI domain.
|
|
|
|
|
|
|
|
|
Identifies records where
the value for Inclusion/Exclusion Criterion Short Name (IETESTCD)
is not found in the TI domain.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
The Study Identifier
(STUDYID) in the TA domain does not match STUDYID in the DM domain.
|
|
|
|
|
|
|
|
|
The study identifier
(STUDYID) in the TA domain does not match STUDYID in the DM domain.
|
|
|
|
|
|
|
|
|
The study identifier
(STUDYID) in the TV domain does not match STUDYID in the DM domain.
|
|
|
|
|
|
|
|
|
The study identifier
(STUDYID) in the TV domain does not match STUDYID in the DM domain.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
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').
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
Order of Element within
Arm (TAETORD) values must match the entries in the Trial Arms (TA)
data set.
|
|
|
|
|
|
|
|
|
Epoch (EPOCH) values
must match the entries in the Trial Arms (TA) data set.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
|
|
Identifies comments
(CO) domain reference to an unknown related domain.
|
|
|
|
|
|
|
|
|
Identifies comments
(CO) domain reference to an unknown related domain.
|
|
|
|
|
|
|
|
|
Identifies records where
value for [Relationship Type (RELTYPE)] is not found in Codelist [CARDINALITY],
limited to records where [RELTYPE is not null].
|
|
|
|
|
|
|
|
|
Identifies Related Records
(RELREC) domain reference to an unknown related domain.
|
|
|
|
|
|
|
|
|
Identifies Related Records
(RELREC) domain reference to an unknown related domain.
|
|
|
|
|
|
|
|
|
Identifies Supplemental
Qualifiers (SUPPQUAL) domain reference to an unknown related domain.
|
|
|
|
|
|
|
|
|
Identifies Supplemental
Qualifiers (SUPPQUAL) domain reference to an unknown related domain.
|
|
|
|
|
|
|
|
|
Identifies Related Records
(RELREC) domain reference to a key variable that is not defined in
the target domain.
|
|
|
|
|
|
|
|
|
Identifies Related Records
(RELREC) domain reference to a key variable that is not defined in
the target domain.
|
|
|
|
|
|
|
|
|
Identifies Supplemental
Qualifiers (SUPPQUAL) domain reference to a key variable that is not
defined in the target domain.
|
|
|
|
|
|
|
|
|
Identifies Supplemental
Qualifiers (SUPPQUAL) domain reference to a key variable that is not
defined in the target domain.
|
|
|
|
|
|
|
|
|
Identifies Related Records
(RELREC) domain reference to a record that does not exist in the target
domain.
|
|
|
|
|
|
|
|
|
Identifies Related Records
(RELREC) domain reference to a record that does not exist in the target
domain.
|
|
|
|
|
|
|
|
|
Identifies Supplemental
Qualifiers (SUPPQUAL) domain reference to a record that does not exist
in the target domain.
|
|
|
|
|
|
|
|
|
Identifies Supplemental
Qualifiers (SUPPQUAL) domain reference to a record that does not exist
in the target domain.
|
|
|
|
|
|
|
|
|
Identifies comments
(CO) domain reference to a record that does not exist in the target
domain.
|
|
|
|
|
|
|
|
|
Identifies comments
(CO) domain reference to a record that does not exist in the target
domain.
|
|
|
|
|
|
|
|
|
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.
|
|
|
|
|