Define-XML v2.0

Page 52 / Section 5.3.3. (ODM Element)

• The name of the xsi:schemalocation attribute should be xsi:schemaLocation

Page 54 / Example 5.3.3.1. (Example XML Header, Stylesheet Reference and ODM Element)

• The ODMVersion attribute value should be "1.3.2" instead of "1.3.1".

Page 55 / Section 5.3.4. (Study Element):

• The name of the Study attribute should be "OID" instead of "StudyOID".

Page 62 / Section 5.3.8.1. (5.3.8.1. ItemRef Element):

• The Element Name should be "ItemRef" instead of "Description".

Page 66 / Section 5.3.9. (def:WhereClauseDef Element):

• The def:CommentOID attribute description should be: 
  Reference to the unique ID of a def:CommentDef that describes how to join the datasets when the WhereClause includes references to variables in different datasets.

• Section 5.3.9.2. (CheckValue Element):
  • The Element Name should be CheckValue instead of RangeCheck.
  • The Element XPath should be: /ODM/Study/MetaDataVersion/def:WhereClauseDef/RangeCheck/CheckValue
  • In the Usage row the cardinality should be "One or more" instead of One"

• Section 5.3.10.1. (Description Element)
  • In the Usage row, under Requirement, the first bullet should be: 
    Required for regulatory submissions or any case where the Define-XML will be checked for compliance with a standard that requires a dataset and variable label.

• Page 67 / Section 5.3.10.2. (Alias Element):

  "EnumeratedITem" should be spelled as "EnumeratedItem" in the Usage row.

• Page 75 / Section 5.3.11. (ItemDef Element):
  • The allowable value for the Length attribute should be "Positive Integer" instead of "Integer".
  • The Business Rule in the Description should be: 
    Length should be defined as the maximum expected variable length. Should only be present for DataType equal to "text", "integer", or "float". 
    In the case of DataType="integer", the length refers to the maximum length of the numeric value expressed in characters.
    In the case of DataType="float", if DataType=float, Length=N and SignificantDigits=S is a requirement that the receiving system be able to process and store all numeric values of magnitude less than 10N-S that are multiples of 10-S." For example, if the value has a pattern xxx.xx, then Length=5 and S=2.

• Page 80 / Section 5.3.11.3. (def:Origin Element):

  • In the Usage row, under Business Rule, the third bullet should be: 
    If the variable or value is derived, the corresponding ItemGroup/ItemRef element must include a MethodOID attribute that references the corresponding MethodDef.

  • Add a new bullet between the second and third bullets:
    If the ItemDef corresponding to a SDTM, ADaM or SEND variable includes a def:ValueListRef and the def:Origin elements of ItemDef elements referenced in the corresponding def:ValueListDef are the same as the def:Origin at the variable level ItemDef, then the def:Origin element does not have to be provided with the value level ItemDef elements.

  • Add the following text to the Allowable Values column of the Type attribute:
    Only in the context of a regulatory submission using SEND the following values are allowed:
    COLLECTED: A designation of "COLLECTED” means that the data were collected via manual or electronic means in a nonclinical study setting. This term should be used for data that were actually observed or recorded by a person or received from an instrument; it should not be used for data that have been calculated, interpreted, or derived from other information.
    DERIVED: "DERIVED” is assigned to values that were not directly collected, but were calculated by an algorithm or reproducible rule which was dependent upon other data values. The derivation is assumed to be performed by the producer of the dataset. This does not apply to derived lab test results performed directly by laboratories (or by devices).
    OTHER: An origin of "OTHER” is used for values whose origin is known but which were neither collected nor derived. Examples could include values sourced from the protocol or which are defined as part of the Trial Design preparation (see Section 7 of the SEND Implementation Guide 3.0) or values created as a part of the preparation of the datasets, such as STUDYID, USUBJID, DOMAIN, --SEQ, or --TESTCD.
    NOT AVAILABLE: "NOT AVAILABLE” means that the origin of the data is not available, such as data received from another laboratory, without the associated annotations or sufficient information provided to determine the actual Origin assignment for the data. Sponsors may specify additional details about the origin that may be helpful to the reviewer in the Comments section of the data definition file.

• Page 82 / Section 5.3.12. (CodeList Element):
  • In the Usage row, under Cardinality, it should be:
    A CodeList element must be provided for each distinct value of the CodelistOID attribute in a CodeListRef element, and the RoleCodelistOID attribute of ItemRef element in the MetaDataVersion.
     
  • The Business Rules for the SASFormatName attribute should be:
    The SASFormatName must be a legal SAS format with length less than 8 characters. The SASFormatName needs to start with a "$" character in case the CodeList DataType is "text".

• Page 85 / Section 5.3.12.2. (CodeListItem Element):
  • The first section of the Rank Description should be:
     Numeric significance of the CodeListItem relative to others in the CodeList.
     
  • The Description column for attribute Name should be:
    Name assigned to the CodeList element.
    Business Rule:
    The Name must be unique within the set of Codelist elements.

• Page 87 / Section 5.3.12.4. (ExternalCodeList Element):
  • The attributes with names "Ref" and "Href" should be changed to lowercase: "ref" and "href".

• Page 88 / Section 5.3.13. (MethodDef Element):
  • In the Usage row, the Business Rule should be:
     Must contain the child Description element and, zero or more child def:DocumentRef elements

• Page 90 / Section 5.3.14. (def:CommentDef Element): 
  • In the Usage row, the Business Rule should be:
     Must contain the child Description element and, zero or more child def:DocumentRef elements

• Page 91 / Section 5.3.15 (def:leaf element):
  • The allowable value for the ID attribute should read:
     Since the leaf ID is based on the XML xs:ID datatype, which is a Non-Colonized Name, ID attributes must start with either a letter or underscore (_), and may contain only letters, digits, underscores, hyphens and periods.

• Page 92 / Section 5.3.15. (def:leaf Element):
  • The attribute with name "Xlink:href" should be changed to lowercase: "xlink:href".

Page 93 / Section 6 (Global Element Ordering): 

• This section should be as below. Updates are marked with <!-- add -->  or <!-- change -->

  <ODM>
    <Study>
    <GlobalVariables>
      <StudyName>
      <StudyDescription>
      <ProtocolName>
    <MetaDataVersion>
      <def:AnnotatedCRF>
        <def:DocumentRef>
      <def:SupplementalDoc>
        <def:DocumentRef>
      <def:ValueListDef>
        <ItemRef>
          <def:WhereClauseRef>
      <def:WhereClauseDef>
        <RangeCheck>
          <CheckValue>
      <ItemGroupDef>
        <Description>
          <TranslatedText>
        <ItemRef>
        <Alias>     <!-- add -->
        <def:leaf>
          <def:title>
      <ItemDef>
        <Description>
          <TranslatedText>
        <CodeListRef>
        <def:Origin>
          <Description>     <!-- add -->
            <TranslatedText>     <!-- add -->
          <def:DocumentRef>
            <def:PDFPageRef>
        <def:ValueListRef>
      <CodeList>
        <EnumeratedItem>
          <Alias>
        <CodeListItem>
          <Decode>
            <TranslatedText>
          <Alias>
        <ExternalCodeList>     <!-- change -->
        <Alias>
      <MethodDef>
        <Description>
          <TranslatedText>
        <FormalExpression>     <!-- add -->
        <def:DocumentRef>
          <def:PDFPageRef>
      <def:CommentDef>
        <Description>
          <TranslatedText>
        <def:DocumentRef>
          <def:PDFPageRef>
      <def:leaf>
        <def:title>