Importing and Exporting a CDISC ODM XML Document

CDISC ODM KeySet Members

In a CDISC ODM XML document, a clinical trials data KeySet references an entity, such as a study, a subject, a study event, and so on. The following is an excerpt from a sample XML document that shows a fully populated KeySet:

<ClinicalData StudyOID="123-456-789" MetaDataVersionOID="v1.1.0">
   <SubjectData SubjectKey="001">
      <StudyEventData StudyEventOID="SE.VISIT1" StudyEventRepeatKey="1">
         <FormData FormOID="FORM.AE" FormRepeatKey="1">
            <ItemGroupData ItemGroupOID="IG.AE" ItemGroupRepeatKey="1" 
               TransactionType="Insert">

Converting CDISC ODM KeySet Members

PROC CDISC imports and exports CDISC ODM KeySet members as follows:

When importing, KeySet members (KeySet attributes) that are in the input XML document are converted to SAS variables and values in the output SAS data set.
When exporting, KeySet members (SAS variables and values) that are in the input SAS data set are converted to KeySet attributes in the output XML document.

The following tables list the results of importing and exporting KeySet members:

Importing KeySet Members from a CDISC ODM XML Document
KeySet Member	Description	Resulting SAS Variable Name *
StudyOID=	Specifies a unique identifier for the study.	__STUDYOID
MetaDataVersionOID=	Specifies the metadata version that is used by the study.	__METADATAVERSIONOID
SubjectKey=	Specifies a subject within the study.	__SUBJECTKEY
StudyEventOID=	Specifies a StudyEventDef in the study.	__STUDYEVENTOID
StudyEventRepeatKey=	Specifies a study event repeat key.	__STUDYEVENTREPEATKEY
FormOID=	Specifies a FormDef in the study.	__FORMOID
FormRepeatKey=	Distinguishes between repeats of the same type of form in a single study event.	__FORMREPEATKEY
ItemGroupOID=	Specifies an ItemGroup in the study.	__ITEMGROUPOID
ItemGroupRepeatKey=	Specifies an ItemGroup repeat key.	__ITEMGROUPREPEATKEY
TransactionType=	Specifies the transaction type, which can be Insert, Update, Remove, Upsert, or Context.	__TRANSACTIONTYPE
* The first two characters in resulting SAS variable names are two underscores to ensure that the name is unique.

Exporting KeySet Members from a SAS Data Set
KeySet Member	Description	Resulting KeySet Attributes	Created By
__STUDYOID	Specifies a unique identifier for the study.	StudyOID=	STUDY statement
__METADATAVERSIONOID	Specifies the metadata version that is used by the study.	MetaDataVersionOID=	METADATAVERSION statement
__SUBJECTKEY	Specifies a subject in the study.	SubjectKey=	Read from the exported SAS data set
__STUDYEVENTOID	Specifies a StudyEventDef in the study.	StudyEventOID=	STUDY statement
__STUDYEVENTREPEATKEY	Specifies a study event repeat key.	StudyEventRepeatKey=	Automatically generated
__FORMOID	Specifies a FormDef in the study.	FormOID=	Automatically generated
__FORMREPEATKEY	Distinguishes between repeats of the same type of form in a single study event.	FormRepeatKey=	Automatically generated
__ITEMGROUPOID	Specifies an ItemGroup in the study.	ItemGroupOID=	Automatically generated
__ITEMGROUPREPEATKEY	Specifies an ItemGroup repeat key.	ItemGroupRepeatKey=	Automatically generated
__TRANSACTIONTYPE	Specifies the transaction type, which can be Insert, Update, Remove, Upsert, or Context.	TransactionType=	INSERT is always used

Processing CDISC ODM KeySet Members

PROC CDISC provides processing options that determine how KeySet members are imported or exported. The following processing options are specified in the ODM statement:

LONGNAMES=NO | YES: when importing or exporting, determines the sources of captured SAS name parameters and controls the maximum length of SAS names that is valid.
ODMMAXIMUMOIDLENGTH=number: when importing, specifies a character length for CDISC ODM KeySet members.
ODMMINIMUMKEYSET=NO|YES: when importing or exporting, specifies whether to limit CDISC ODM KeySet members that are in the study data.

For more information about processing options, see the ODM Statement.

For examples of how the KeySet processing options affect the data in an import operation, see Example: Importing a CDISC ODM XML Document Using Default KeySet Processing, and Example: Importing a CDISC ODM XML Document Specifying KeySet Processing Options.

Top of Page