CDISC SDTM 3.1.1 Validation Rules

The following is a listing of CDISC SDTM version 3.1.1 validation rules supported by OpenCDISC Validator. The list includes all Janus validation rules as defined in the Janus SDTM Validation Specification v.1 and 10 additional rules defined by the OpenCDISC community.

Rule ID	Message	Description of Rule	Domain	Category	Type	WebSDM ID
CT0004	Value for AGEU not found in AGEU controlled terminology codelist	Variable values should be populated with terms found in 'Age Unit' (C66781) CDISC controlled terminology codelist	DM	Terminology	Error	R4062
CT0006	Value for COUNTRY not found in COUNTRY controlled terminology codelist	Variable values should be populated with terms found in 'Country' (C66786) CDISC controlled terminology codelist	DM	Terminology	Warning	R4008
CT0020	Value for IECAT not found in IECAT controlled terminology codelist	Variable values should be populated with terms found in 'Category for Inclusion/Exclusion' (C66797) CDISC controlled terminology codelist	IE	Terminology	Warning	R4031
CT0034	Value for SEX not found in SEX controlled terminology codelist	Variable values should be populated with terms found in 'Sex' (C66731) CDISC controlled terminology codelist	DM	Terminology	Error	R4007
CT0038	Value for --STRF not found in STENRF controlled terminology codelist	Variable values should be populated with terms found in 'Relation to Reference Period' (C66728) CDISC controlled terminology codelist	Timing	Terminology	Error	IR4108
CT0039	Value for --ENRF not found in STENRF controlled terminology codelist	Variable values should be populated with terms found in 'Relation to Reference Period' (C66728) CDISC controlled terminology codelist	Timing	Terminology	Error	IR4104
CT0044	Value for AETOXGR not found in TOXGR controlled terminology codelist	Variable values should be populated with terms found in 'Common Terminology Criteria for Adverse Events V4.0' (C87162) CDISC controlled terminology codelist	AE	Terminology	Warning	IR4121
CT0059	Value for --BLFL not found in NY controlled terminology codelist	Identifies records that violate the condition [Baseline Flag either 'Y' or null]	Findings	Terminology	Warning	IR4102
CT0060	Value for --DRVFL not found in NY controlled terminology codelist	Identifies records that violate the condition [Derived Flag either 'Y' or null]	Findings	Terminology	Error	IR4103
CT0061	Value for --FAST not found in NY controlled terminology codelist	Variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	Findings	Terminology	Error	IR4105
CT0062	Value for --OCCUR not found in NY controlled terminology codelist	Variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	Events, Interventions	Terminology	Error	IR4106
CT0064	Value for AESER not found in NY controlled terminology codelist	Variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	AE	Terminology	Error	R4019
CT0065	Value for AESCONG not found in NY controlled terminology codelist	Variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	AE	Terminology	Error	R4023
CT0066	Value for AESDISAB not found in NY controlled terminology codelist	Variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	AE	Terminology	Error	R4024
CT0067	Value for AESDTH not found in NY controlled terminology codelist	Variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	AE	Terminology	Error	R4025
CT0068	Value for AESHOSP not found in NY controlled terminology codelist	Variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	AE	Terminology	Error	R4026
CT0069	Value for AESLIFE not found in NY controlled terminology codelist	Variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	AE	Terminology	Error	R4027
CT0070	Value for AECONTRT not found in NY controlled terminology codelist	Variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	AE	Terminology	Error	R4043
CT0071	Value for AESCAN not found in NY controlled terminology codelist	Variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	AE	Terminology	Error	R4045
CT0072	Value for AESMIE not found in NY controlled terminology codelist	Variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	AE	Terminology	Error	R4046
CT0073	Value for AESOD not found in NY controlled terminology codelist	Variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	AE	Terminology	Error	R4047
CT0074	Value for IEORRES not found in NY controlled terminology codelist	Variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	IE	Terminology	Error	R4071
CT0075	Value for IESTRESC not found in NY controlled terminology codelist	Variable values should be populated with terms found in 'No Yes Response' (C66742) CDISC controlled terminology codelist	IE	Terminology	Error	R4072
CT0076	Value for --STAT not found in ND controlled terminology codelist	Variable values should be populated with terms found in 'Not Done' (C66789) CDISC controlled terminology codelist	All	Terminology	Warning	IR4107
SD0001	No records in data source	Identifies domain table that has zero rows and therefore contains no data.	All	Presence	Warning	IR4000
SD0002	Null value in variable marked as Required	Required variables (where Core attribute is 'Req') cannot be null for any record.	All	Presence	Error	IR4001
SD0003	Invalid ISO 8601 value	Dates and times of day must conform to the ISO 8601 international standard.	All	Format	Error	IR4002
SD0004	Inconsistent value for DOMAIN	Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset.	All	Consistency	Warning	IR4003
SD0005	Non-unique value for SEQ	Identifies records where non-unique values for Sequence Number variable exist within a subject.	All	Consistency	Error	IR4004
SD0006	No baseline result in [Domain] for subject	All subjects should have at least one baseline observation (--BLFL = 'Y') in EG, LB, QS, and VS domains, except for subjects who failed screening (ARMCD = 'SCRNFAIL') or were not fully assigned to an Arm (ARMCD = 'NOTASSGN').	EG, LB, QS, VS	Presence	Warning	IR4005
SD0007	Inconsistent value for Standard Unit	Identifies Short Name of Measurement, Test or Examination values where standard units value (Standard Units) is not consistent across all records	EG, LB, QS, VS	Consistency	Error	IR4006
SD0008	Value for AEDECOD not found in MedDRA Preferred Term codelist	Variable values should be populated with terms found in 'Preferred Term' codelist from MedDRA dictionary	AE	Terminology	Error	IR4007
SD0009	AE is Serious but no qualifiers set to 'Y'	Identifies records where Serious Event='Y' but none of Involves Cancer, Congenital Anomaly or Birth Defect, Persist or Signif Disability/Incapacity, Results in Death, Requires or Prolongs Hospitalization, Is Life Threatening, Other Medicaly Important Serious Event, or Occured with Overdose equals 'Y'	AE	Consistency	Warning	IR4008
SD0010	VISITNUM should not be formatted to more than 3 decimal places	Identifies records where the value for Visit Number is formatted to more than three decimal places	All	Format	Warning	IR4010
SD0011	If ARMCD equals 'SCRNFAIL' then ARM must equal 'Screen Failure'	When Arm Code (ARMCD) is equal to 'SCRNFAIL', then Description of Arm (ARM) must equal 'Screen Failure', and vice versa.	DM, TA	Consistency	Error	IR4011
SD0012	Begin day must be less than or equal to end day	Identifies records that violate the condition [(Study Day of Start of Observation less than or equal to Study Day of End of Observation)], limited to records where [Study Day of Start of Observation is not null and Study Day of End of Observation is not null]	Timing	Limit	Error	IR4100
SD0013	Begin day must be less than or equal to end day	Identifies records that violate the condition [(Start Date/Time of Observation less than or equal to End Date/Time of Observation)], limited to records where [Start Date/Time of Observation is not null and End Date/Time of Observation is not null]	Timing	Limit	Error	IR4101
SD0014	DOSE must be non-negative	Identifies records that violate the condition [Dose greater than or equal to 0], limited to records where [Dose is not null]	Interventions	Limit	Error	IR4109
SD0015	Duration must be non-negative	Identifies records that violate the condition [Duration greater than or equal to 0], limited to records where [Duration is not null]	Timing	Limit	Error	IR4110
SD0016	Derived Flag = 'Y' but (Character) Standard Result is null	Identifies records that violate condition [Result or Finding in Standard Format is not null], limited to records where [Derived Flag='Y']	Findings	Consistency	Warning	IR4112
SD0017	Invalid value for --TEST variable	Identifies records that violate condition [LENGTH(Name of Measurement, Test or Examination) less than or equal to 40 characters]	Findings	Format	Warning	IR4113
SD0018	Invalid value for --TESTCD variable	Identifies records that violate condition [LENGTH(Short Name of Measurement, Test or Examination) less than or equal to 8 chars, cannot start with a number or contain special chars]	Findings	Format	Warning	IR4114
SD0019	Invalid value for --PARM variable	Identifies records that violate the condition [LENGTH(Trial Summary Parameter) less than or equal to 40 characters]	TS	Format	Warning	IR4115
SD0020	Invalid value for --PARMCD variable	Identifies records that violate the condition [LENGTH(Trial Summary Parameter Short Name) less than or equal to 8 chars, cannot start with a number or contain special chars]	TS	Format	Warning	IR4116
SD0021	--ENRF expected when --ENDTC is null	Identifies records that violate the condition [End Relative to Reference Period is not null], limited to records where [End Date/Time of Observation is null] and [Occurrence doesn't equal 'N']	Timing	Consistency	Warning	IR4117
SD0022	--STRF expected when --STDTC is null	Identifies records that violate the condition [Start Relative to Reference Period is not null], limited to records where [Start Date/Time of Observation is null] and [Occurrence doesn't equal 'N']	Timing	Consistency	Warning	IR4118
SD0023	--REASND given but --STAT is null	When Reason Not Done (--REASND) is populated, then Completion Status (--STAT) must be set to 'NOT DONE'	All	Consistency	Warning	IR4122
SD0024	Start date expected when end date provided	Identifies records that violate the condition [Date/Time of Collection is not null], limited to records where [End Date/Time of Observation is not null]	Findings	Consistency	Warning	IR4123
SD0025	Start date must be before end date	Identifies records that violate the condition [Date/Time of Collection is less than or equal to End Date/Time of Observation], limited to records where [Date/Time of Collection is not null and End Date/Time of Observation exists]	Findings	Limit	Error	IR4124
SD0026	Missing units on value	Identifies records that violate the condition [Original Units is not null], limited to records where [Result or Finding in Original Units is not null]	Findings	Consistency	Warning	IR4125
SD0027	Missing value although units provided	Identifies records that violate the condition [Original Units is null], limited to records where [Result or Finding in Original Units is null]	Findings	Consistency	Warning	IR4126
SD0028	Upper limit must be greater than or equal to lower limit	Identifies records that violate the condition [Normal Range Upper Limit-Standard Units greater than or equal to Normal Range Lower Limit-Standard Units], limited to records where [Normal Range Upper Limit-Standard Units is not null and Normal Range Lower Limit-Standard Units is not null]	Findings	Limit	Error	IR4127
SD0029	Missing units on value	Identifies records that violate the condition [Standard Units is not null], limited to records where [Result or Finding in Standard Format is not null]	Findings	Consistency	Warning	IR4128
SD0030	Missing value although units provided	Identifies records that violate the condition [Standard Units is null], limited to records where [Result or Finding in Standard Format is null]	Findings	Consistency	Warning	IR4129
SD0031	Start date expected when end date provided	Identifies records that violate the condition [Start Date/Time of Observation or Start Relative to Reference Period is not null], limited to records where [End Date/Time of Observation or End Relative to Reference Period is not null]	Timing	Consistency	Warning	IR4130
SD0032	Timepoint (character) missing when timepoint number provided	Identifies records that violate the condition [Planned Time Point Name is not null], limited to records where [Planned Time Point Number is not null]	Timing	Consistency	Warning	IR4131
SD0033	Timepoint number missing when timepoint (character) provided	Identifies records that violate the condition [Planned Time Point Number is not null], limited to records where [Planned Time Point Name is not null]	Timing	Consistency	Warning	IR4132
SD0034	Timepoint reference (character) missing when elapsed time from reference point provided	Identifies records that violate the condition [Time Point Reference is not null], limited to records where [Elapsed Time from Reference Point is not null]	Timing	Consistency	Warning	IR4133
SD0035	Missing units on value	Identifies records that violate the condition [Dose Units is not null], limited to records where [Dose is not null]	Interventions	Consistency	Error	IR4134, IR4138
SD0036	Missing character result when original result provided	Identifies records that violate the condition [Result or Finding in Standard Format is not null], limited to records where [Result or Finding in Original Units is not null]	Findings	Consistency	Error	IR4135
SD0037	Value for [Variable] not found in [CodeList] user-defined codelist	Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml.	All	Terminology	Warning	IR4136
SD0038	--DY must not equal 0	Identifies records that violate the condition [Study Day of Visit/Collection/Exam doesn't equal 0]	All	Limit	Warning	IR4137
SD0039	RDOMAIN should not be null	Domain Abbreviation of the Parent record (RDOMAIN) in SUPPQUAL and RELREC datasets should not be null. The only exception is when data applies to all records in all domains for a subject (e.g., ITT).	SUPPQUAL, RELREC	Presence	Warning	IR4139
SD0040	Inconsistent value for Name of Measurement, Test, or Examination	For a given value of Short Name of Measurement, Test or Examination (--TESTCD), all values of Name of Measurement, Test or Examination (--TEST) should be the same	Findings	Consistency	Warning	IR4142
SD0046	Inconsistent value for Qualifier Variable Label	For a given value of Qualifier Variable Name (QNAM), all values of Qualifier Variable Label (QLABEL) should be the same	SUPPQUAL	Consistency	Warning	IR4161
SD0047	--ORRES is null but --STAT or --DRVFL are not specified	When Result or Finding in Original Units (--ORRES) is null, then Status (--STAT) must be set to 'NOT DONE' or Derived Flag (--DRVFL) must have a value of 'Y'	Findings	Consistency	Warning	IR4162
SD0048	--ORRES has a value but --STAT is NOT DONE	When Result or Finding in Original Units (--ORRES) is provided, then Status (--STAT) must be null	Findings	Consistency	Warning	IR4163
SD0051	Inconsistent value for Visit Name	For a given value of Visit Number (VISITNUM), all values of Visit Name (VISIT) should be the same	SV, TV	Consistency	Warning	IR4170
SD0052	Inconsistent value for Visit Number	For a given value of Visit Name (VISIT), all values of Visit Number (VISITNUM) should be the same	SV, TV	Consistency	Warning	IR4171
SD0053	If ARMCD equals 'NOTASSGN' then ARM must equal 'Not Assigned'	When Arm Code (ARMCD) is equal to 'NOTASSGN', then Description of Arm (ARM) must equal 'Not Assigned', and vice versa.	DM, TA	Consistency	Error	IR4172
SD0054	Variable in define.xml not in dataset	Variables listed in the data definition document (define.xml) should be included in the dataset.	All	Metadata	Warning	IR4250
SD0055	SDTM/dataset variable type mismatch	Variable Data Types in the dataset should match the variable data types described in SDTM.	All	Metadata	Error	IR4251
SD0056	SDTM Required variable not found	Variables described in SDTM as Required must be included in the dataset.	All	Metadata	Error	IR4252
SD0057	SDTM Expected variable not found	Variables described in SDTM as Expected should be included in the dataset.	All	Metadata	Warning	IR4253
SD0058	Variable appears in dataset but is not in SDTM standard	Only variables listed in SDTM should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified.	All	Metadata	Warning	IR4254
SD0059	Define.xml/dataset variable type mismatch	Variable Data Types in the dataset must match the variable data types described in the data definition document (define.xml).	All	Metadata	Error	IR4259
SD0060	Variable in dataset not in define.xml	Variables included in the dataset must be described in the data definition document (define.xml).	All	Metadata	Error	IR4260
SD0061	Domain referenced in define.xml but dataset is missing	Domains referenced in data definition document (define.xml) should be included in the submission.	All	Metadata	Warning	IR4261
SD0062	Incompatible data source	Identifies a domain whose source data failed to load	All	System	Error	IR4262
SD0063	SDTM/dataset variable label mismatch	Variable Label in the dataset should match the variable label described in SDTM. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted.	All	Metadata	Warning	IR4264
SD0064	Invalid subject	Identifies non-Demographics domain subjects not found in the Demographics domain	All	Cross-reference	Error	IR4500
SD0065	Invalid Subject Visit/Visit Number	Identifies Unique Subject Identifier+Visit Name+Visit Number combination not found in the SV domain	All	Cross-reference	Warning	IR4501
SD0066	Invalid ARMCD	Planned Arm Code (ARMCD) values must match entries in the Trial Arms (TA) dataset, except for subjects who failed screening (ARMCD = 'SCRNFAIL').	DM	Cross-reference	Warning	IR4502
SD0067	Invalid ETCD	Element Code (ETCD) values must match entries in the Trial Elements (TE) dataset, except for unplanned Element (ETCD = 'UNPLAN').	All	Cross-reference	Warning	IR4503
SD0068	Invalid IETESTCD	Identifies records where the value for Inclusion/Exclusion Criterion Short name is not found in the TI domain	IE	Cross-reference	Error	IR4504
SD0069	No Disposition record found for subject	All Demographics subjects should have at least one record in Disposition domain.	DM	Presence	Warning	IR4505
SD0070	No Exposure record found for subject	All Demographics subjects participating in a study that includes investigational product should have at least one record in Exposure domain, except for subjects who failed screening (ARMCD = 'SCRNFAIL') or were not fully assigned to an Arm (ARMCD = 'NOTASSGN').	DM	Presence	Warning	IR4506
SD0071	Invalid ARM/ARMCD	The combination of Description of Planned Arm (ARM) and Planned Arm Code (ARMCD) values must match entries in the Trial Arms (TA) dataset, except for subjects who failed screening (ARMCD = 'SCRNFAIL').	DM	Cross-reference	Error	IR4507
SD0072	Referenced Domain not found	When comments are related to a domain, then the value of Related Domain Abbreviation (RDOMAIN) variable must reference the Domain Code of the parent domain.	CO	Consistency	Error	IR4508
SD0073	Referenced Domain not found	Identifies Related Records domain reference to an unknown related domain	RELREC	Consistency	Error	IR4509
SD0074	Referenced Domain not found	Identifies Supplemental Qualifiers domain reference to an unknown related domain	SUPPQUAL	Consistency	Error	IR4510
SD0075	Referenced key variable not found	Identifies Related Records domain reference to a key variable that isn't defined in the target domain	RELREC	Consistency	Error	IR4511
SD0076	Referenced key variable not found	Identifies Supplemental Qualifiers domain reference to a key variable that isn't defined in the target domain	SUPPQUAL	Consistency	Error	IR4512
SD0077	Referenced record not found	Identifies Related Records domain reference to a record that doesn't exist in the target domain	RELREC	Cross-reference	Error	IR4513
SD0078	Referenced record not found	Identifies Supplemental Qualifiers domain reference to a record that doesn't exist in the target domain	SUPPQUAL	Cross-reference	Error	IR4514
SD0080	AE start date must be less than or equal to latest disposition date	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	Consistency	Warning	IR4517
SD0081	Observation date must be less than or equal to latest disposition date	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	Consistency	Warning	IR4517
SD0082	Exposure end date must be less than or equal to latest disposition date	End Date/Time of Treatment (EXENDTC) must be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC)	EX	Consistency	Warning	IR4517
SD0083	Duplicate USUBJID	The value of Unique Subject Identifier (USUBJID) variable must be unique for each subject across all trials in the submission.	DM	Consistency	Error
SD0084	Negative AGE value	The value of Age (AGE) cannot be less than 0.	DM	Limit	Error	R4006
SD0085	IEORRES and IESTRESC must have the same value	Identifies records that violate the condition [I/E Criterion Original Result = I/E Criterion Result in Std Format]	IE	Consistency	Warning	R4073
SD0086	Duplicates	Identifies records where values for [Study Identifier, Unique Subject Identifier, Identifying Variable, Identifying Variable Value, Qualifier Variable Name] variables(s) are not unique	SUPPQUAL	Consistency	Error	R4083
SD0087	RFSTDTC cannot be null for randomized subject	Subject Reference Start Date/Time (RFSTDTC) is required for all randomized subjects, those where Planned Arm Code (ARMCD) is not equal to 'SCRNFAIL'.	DM	Consistency	Warning	R4096
SD0088	RFENDTC cannot be null for randomized subject	Subject Reference End Date/Time (RFENDTC) is required for all randomized subjects, those where Planned Arm Code (ARMCD) is not equal to 'SCRNFAIL'.	DM	Consistency	Warning	R4097
SD0089	Rule end for element (TEENRL) and planned duration of element (TEDUR) cannot both be null	Identifies records that violate the condition [Rule for End of Element is not null or Planned Duration of Element is not null]	TE	Consistency	Warning	R4101
SD0090	AESDTH='Y' expected when AEOUT='FATAL'	Identifies records that violate the condition [Results in Death='Y'], limited to records where [Outcome of Adverse Event='FATAL']	AE	Consistency	Warning	R4102
SD0091	AEOUT='FATAL' expected when AESDTH='Y'	Identifies records that violate the condition [Outcome of Adverse Event='FATAL'], limited to records where [Results in Death='Y']	AE	Consistency	Warning	R4103
SD0092	Missing description of unplanned element when ETCD='UNPLAN'	When subject's experience for a particular period of time is represented as an unplanned Element, where Element Code (ETCD) is equal to 'UNPLAN', then Description of Unplanned Element (SEUPDES) should be populated.	SE	Consistency	Warning	R4105
SD0093	Missing units on value	When Age (AGE) is not null, then Age Units (AGEU) should be provided.	DM	Consistency	Warning	R4106
SD0095	Supplemental Qualifiers only allowed for subject-related domains	Supplemental Qualifiers special purpose dataset (SUPP--) can only be used to capture non-standard variables and their association to parent records in general-observation-class datasets (Events, Findings, Interventions) and Demographics.	SUPPQUAL	Presence	Error	IR4258
SD1001	Duplicate SUBJID	The value of Subject Identifier for the Study (SUBJID) variable must be unique for each subject within the study.	DM	Consistency	Error
SD1002	Start date must be before end date	Subject Reference Start Date/Time (RFSTDTC) must be less than or equal to Subject Reference End Date/Time (RFENDTC).	DM	Limit	Error
SD1003	Missing value although units provided	When Age Units (AGEU) are not null, then Age (AGE) should be provided.	DM	Consistency	Warning
SD1005	STUDYID value does not match STUDYID in DM domain	Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain.	All	Consistency	Error
SD1006	Referenced key variable not found	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	Consistency	Error
SD1007	Referenced record not found	When comments are related to a specific parent record or group of parent records in a domain, then the values of Identifying Variable (IDVAR) and Identifying Variable Value (IDVARVAL) must reference a key variable name and value of the parent record(s) in the parent domain.	CO	Cross-reference	Error
SD1008	CODTC should be null if comment is a child record of another domain	When comments are related to a specific parent record or group of parent records in a domain, then the value of Date/Time of Comment (CODTC) should be null because the timing of the parent record(s) is inherited by the comment record.	CO	Consistency	Warning
SD1010	ELEMENT should be null for unplanned element	When subject's experience for a particular period of time is represented as an unplanned Element, where Element Code (ETCD) is equal to 'UNPLAN', then Description of Element (ELEMENT) should be null.	SE	Consistency	Warning
SD1011	Invalid ISO 8601 value	Duration, Elapsed Time, and Interval values must conform to the ISO 8601 international standard.	All	Format	Error
SD1012	Invalid ETCD/ELEMENT	The combination of Element Code (ETCD) and Description of Element (ELEMENT) values must match entries in the Trial Elements (TE) dataset, except for unplanned Element (ETCD = 'UNPLAN').	SE, TA	Cross-reference	Warning
SD1014	Invalid TAETORD	Order of Element within Arm (TAETORD) values must match entries in the Trial Arms (TA) dataset.	Timing	Cross-reference	Warning
SD1015	Invalid EPOCH	Epoch (EPOCH) values must match entries in the Trial Arms (TA) dataset.	Timing	Cross-reference	Warning
SD1016	Invalid IETESTCD/IETEST/IECAT	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) dataset.	IE	Cross-reference	Warning
SD1017	Invalid VISITNUM	For planned visits, where Description of Unplanned Visit (SVUPDES) is null, Visit Number (VISITNUM) values must match entries in the Trial Visits (TV) dataset.	SV	Cross-reference	Warning
SD1018	Invalid VISITNUM/VISIT/VISITDY	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 entries in the Trial Visits (TV) dataset.	SV	Cross-reference	Warning
SD1019	VISITDY should be null for unplanned visits	For unplanned visits, where Description of Unplanned Visit (SVUPDES) is populated, Planned Study Day of Visit (VISITDY) should be null.	SV	Consistency	Warning
SD1020	Missing DM dataset	Demographics (DM) dataset should be included in every submission.	DM	Presence	Error