CDISC Define.xml 1.0 Validation Rules

The following is a listing of CDISC Define.xml version 1.0 validation rules supported by OpenCDISC Validator.

Rule ID Message Description of Rule Category Type
DD0002 Missing or invalid namespace reference In addition to default CDISC ODM namespace, the Define.xml must reference XML Schema Instance (xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"), XLink (xmlns:xlink="http://www.w3.org/1999/xlink"), CDISC Define (xmlns:def="http://www.cdisc.org/ns/def/v1.0") namespaces. Structure Error
DD0003 Required attribute is missing or empty Required attributes must be included in Define.xml and cannot be empty. Presence Error
DD0004 Unknown attribute The Define.xml must contain only attributes defined in the standard. Metadata Warning
DD0005 Attribute in wrong position within Define.xml An attribute was found in the wrong position within Define.xml. Metadata Error
DD0006 Required element is missing or empty Required elements must be included in Define.xml and cannot be empty. Presence Error
DD0007 Unknown element The Define.xml must contain only elements defined in the standard. Metadata Warning
DD0008 Element in wrong position within Define.xml An element was found in the wrong position within Define.xml. Metadata Error
DD0009 Element occurs more than once Element occurs in Define.xml more than once, but it is limited to only one occurrence by the specification. Consistency Error
DD0010 ODM attribute should not be included in Define.xml ODM attributes that are optional and are not explicitly specified in Define.xml standard should not be included. Metadata Warning
DD0011 ODM element should not be included in Define.xml ODM elements that are optional and are not explicitly specified in Define.xml standard should not be included. Metadata Warning
DD0012 Duplicate 'def:leaf' element The ID attribute for def:leaf element must be unique within a single MetaDataVersion. Consistency Error
DD0013 Duplicate 'def:ComputationMethod' element The OID attribute for def:ComputationMethod element must be unique within a single MetaDataVersion. Consistency Error
DD0014 Duplicate 'def:ValueListDef' element The OID attribute for def:ValueListDef element must be unique within a single MetaDataVersion. Consistency Error
DD0015 Referenced 'def:leaf' not found The value of leafID attribute references a non-existent def:leaf element. Cross-reference Error
DD0016 Referenced 'def:ComputationMethod' not found The value of def:ComputationMethodOID attribute references a non-existent def:ComputationMethod element. Cross-reference Error
DD0017 Referenced 'def:ValueListDef' not found The value of def:ValueListDefOID attribute references a non-existent def:ValueListDef element. Cross-reference Error
DD0018 def:ArchiveLocationID/def:leaf mismatch The ItemGroupDef def:ArchiveLocationID should match the ID of the child def:leaf Consistency Error
DD0019 Invalid 'FileType' value The FileType must have a value of 'Snapshot'. Terminology Error
DD0020 Invalid 'def:DefineVersion' value The def:DefineVersion should have a value of '1.0.0'. Terminology Warning
DD0021 Invalid 'def:StandardName' value The def:StandardName should have a value of 'CDISC SDTM', 'CDISC SEND', or 'CDISC ADaM'. Terminology Warning
DD0022 Invalid 'def:StandardVersion' value The def:StandardVersion should have a valid value for the given external standard. Allowed values are '3.1.0', '3.1.1', or '3.1.2' for CDISC SDTM, '2.3' or '3.0' for CDISC SEND, and '1.0 for CDISC ADaM. Terminology Warning
DD0023 Element in wrong order within Define.xml An element was found in the wrong order within Define.xml. Metadata Error
DD0024 Invalid Codelist for variable The allowed values for this variable are restricted by a non-extensible CDISC controlled terminology codelist, however the CodeList referenced in define.xml contains items that are not part of CDISC codelist. Metadata Error
OD0001 XML is not well-formed The ODM file must contain well-formed XML. Structure Error
OD0002 Missing or invalid Namespace attribute The ODM file must reference the CDISC ODM namespace 'http://www.cdisc.org/ns/odm/v1.2'. Structure Error
OD0003 Required attribute is missing or empty Required attributes must be included in ODM file and cannot be empty. Presence Error
OD0006 Required element is missing or empty Required elements must be included in ODM file and cannot be empty. Presence Error
OD0009 Element occurs more than once Element occurs in ODM file more than once, but it is limited to only one occurrence by the specification. Consistency Error
OD0010 Missing XML declaration The ODM file must start with an XML declaration. Structure Error
OD0011 Invalid XML encoding The ODM file must use UTF-8, UTF-16, or ISO-8859-1 encoding. Structure Error
OD0012 Invalid root element The ODM file must contain a root element called ODM. Structure Error
OD0013 Invalid integer value Attribute or element is defined as an integer, but text string does not match the named data format. Allowed string pattern for an integer is '-?digit+'. Format Error
OD0014 Invalid float value Attribute or element is defined as a float, but text string does not match the named data format. Allowed string pattern for a float is '-?digit+(.digit+)?'. Format Error
OD0015 Invalid date value Attribute or element is defined as a date, but text string does not match the named data format. Allowed string pattern for a date is 'YYYY-MM-DD'. Format Error
OD0016 Invalid time value Attribute or element is defined as a time, but text string does not match the named data format. Allowed string pattern for a time is 'hh:mm:ss(.n+)? ((+|-)hh:mm)?'. Format Error
OD0017 Invalid datetime value Attribute or element is defined as a datetime, but text string does not match the named data format. Allowed string pattern for a datetime is 'YYYY-MM-DD T hh:mm:ss(.n+)? ((+|-)hh:mm)?'. Format Error
OD0018 Invalid sasName value Attribute or element is defined as a sasName, but text string does not match the named data format. Allowed string pattern for a sasName is '(letter|_)(letter|digit|_)*'. Format Error
OD0019 Invalid sasFormat value Attribute or element is defined as a sasFormat, but text string does not match the named data format. Allowed string pattern for a sasFormat is '(letter|_|$)(letter|digit|_|.)*'. Format Error
OD0020 Invalid fileName value Attribute or element is defined as a fileName, but text string does not match the named data format. Allowed string pattern for a fileName is '(letter|digit|_|.)+'. Format Error
OD0021 Invalid languageTag value Attribute or element is defined as a languageTag, but text string does not match the named data format. Allowed values are specified in IETF RFC 3066: Tags for the Identification of Languages. Format Error
OD0022 Duplicate 'Study' element The OID attribute for Study element must be unique within a related series of ODM documents. Consistency Error
OD0027 Duplicate 'MetaDataVersion' element The OID attribute for MetaDataVersion element must be unique within a single study. Consistency Error
OD0030 Duplicate 'ItemGroupDef' element The OID attribute for ItemGroupDef element must be unique within a single MetaDataVersion. Consistency Error
OD0031 Duplicate 'ItemDef' element The OID attribute for ItemDef element must be unique within a single MetaDataVersion. Consistency Error
OD0032 Duplicate 'CodeList' element The OID attribute for CodeList element must be unique within a single MetaDataVersion. Consistency Error
OD0041 Duplicate 'ItemRef' element The ItemOID attribute for ItemRef element must be unique within a single ItemGroupDef. Consistency Error
OD0042 Duplicate 'OrderNumber' The OrderNumber attribute for ItemRef element must be unique within a single ItemGroupDef. Consistency Warning
OD0046 Referenced 'ItemDef' not found The value of ItemOID attribute references a non-existent ItemDef element. Cross-reference Error
OD0048 Referenced 'CodeList' not found The value of CodeListOID attribute references a non-existent CodeList element. Cross-reference Error
OD0070 Required attribute 'Length' is missing or empty The Length attribute is required when DataType is integer, float, or text. Presence Error
OD0071 Required attribute 'SignificantDigits' is missing or empty The SignificantDigits attribute is required when DataType is float. Presence Error
OD0072 Invalid 'Repeating' value The Repeating flag must have a value of 'Yes' or 'No'. Terminology Error
OD0073 Invalid 'IsReferenceData' value The IsReferenceData flag must have a value of 'Yes' or 'No'. Terminology Error
OD0074 Invalid 'Mandatory' value The Mandatory flag must have a value of 'Yes' or 'No'. Terminology Error
OD0075 Invalid 'DataType' value The DataType attribute for ItemDef element must have a value of 'integer', 'float', 'date', 'datetime', 'time', or 'text'. Terminology Error
OD0076 Invalid 'DataType' value The DataType attribute for CodeList element must have a value of 'integer', 'float', or 'text'. Terminology Error
OD0077 Invalid 'CodedValue' The CodedValue must match the DataType of the containing CodeList. Format Error
OD0078 Invalid 'SASFormatName' value When CodeList DataType is 'text' the SASFormatName should start with a '$'. Format Warning
OD0079 Duplicate 'CodedValue' The CodedValue must be unique within a single CodeList. Consistency Error
OD0080 ItemDef/CodeList 'DataType' mismatch The ItemDef DataType should match the DataType of the referenced CodeList. Consistency Error
OD0081 CodeList permitted values are missing The discrete set of permitted values in a CodeList must be defined as an explicit list of values 'CodeListItem*' or as a reference to an externally defined codelist 'ExternalCodeList'. Consistency Error
OD0082 CodeListItem and ExternalCodeList are both defined The CodeList must contain 'CodeListItem*' or 'ExternalCodeList' elements, but not both. Consistency Error