CDISC ODM 1.3.0

(Source: CDISC Web site http://www.cdisc.org/odm)

The CDISC ODM standard facilitates the archival and interchange of the metadata and data for clinical research. ODM is a vendor-neutral, platform-independent format for the interchange and archival of clinical study data. ODM includes the clinical data and its associated metadata, administrative data, reference data, and audit information. All of the information that needs to be shared during setup, operation, analysis, and submission, as well as for long-term retention as part of an archive, is included in ODM.

CDISC ODM, Version 1.3.0, December 15, 2006

SAS Clinical Standards Toolkit 1.3 provides only partial support of CDISC ODM 1.3.0. The current release of SAS Clinical Standards Toolkit supports reading an odm.xml file, and translating the metadata (<Study>) and clinical data (<ClinicalData>) sections of the odm.xml file into a SAS representation. The domain and column metadata that constitute the SAS representation of CDISC ODM 1.3.0 are derived from the global standards library in these formats:

As a general rule, the SAS representation of the CDISC ODM standard is patterned to match the XML element (data set) and attribute (column) structure of odm.xml. For example, consider the following XML extract:

<ClinicalData StudyOID="P2006-101" MetadataVersionOID="101.01">
 <SubjectData SubjectKey="1000" TransactionType="Insert">
  <StudyEventData StudyEventOID="101.Screen">
   <FormData FormOID="101.DEMOG">
    <ItemGroupData ItemGroupOID="101.DM">
     <ItemDataString ItemOID="101.USUBJID">101-01-01</ItemDataString>
     <ItemDataString ItemOID="101.SEX">F</ItemDataString>
    </ItemGroupData>
   </FormData>
  </StudyEventData>
 </SubjectData>
</ClinicalData>

The following table describes how the XML element and attribute information maps to the SAS representation.

The following table lists the complete set of 52 tables that form the SAS Clinical Standards Toolkit SAS representation of the CDISC ODM 1.3.0 standard.

The highly structured nature of CDISC ODM data requires that any mapping to a relational format include a large number of data sets, with foreign key relationships to help preserve the intended non-relational object structure. In the SAS Clinical Standards Toolkit, foreign key relationships are enforced when validating the CDISC ODM data sets.

Field lengths in the CDISC ODM data sets are consistent by core data type. CDISC has not specified any limit to the length of most character fields. Arbitrary lengths have been chosen by data type. These lengths are listed in the following table. In the table, standard data types are distilled into core data types. To be safe, larger lengths have been chosen to ensure that no data loss occurs in the SAS Clinical Standards Toolkit pre-installed data sets. Production tables might be compressed using SAS mechanisms to preserve disk space.

The table metadata for the 52 data sets and the column metadata for the 241 columns in those data sets that comprise the SAS representation of the CDISC ODM 1.3.0 standard are in the following folder:

<global standards library directory>/standards/cdisc-odm-1.3.0-1.3/metadata.

Table metadata is in reference_tables.sas7bdat, and column metadata is in reference_columns.sas7bdat.

In the future, the CDISC ODM reference standard will support reading and representing in SAS a complete odm.xml file, building an odm.xml file, and validating the structure and content of the SAS representation of an odm.xml file. In addition, it will validate the structural integrity of the odm.xml file. To support this functionality, supplemental files include the following global standards library files:

It is this set of files, in whole or in part, that defines the CDISC ODM reference standard.