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ODM2CDA and CDA2ODM: tools to convert documentation forms between EDC and EHR systems.

Dugas M - BMC Med Inform Decis Mak (2015)

Bottom Line: An open source reference implementation was designed and implemented to convert forms between ODM and CDA format.There are limitations of this conversion method due to different scope and design of ODM and CDA.Specifically, CDA has a multi-level hierarchical structure and CDA nodes can contain both XML values and XML attributes.

View Article: PubMed Central - PubMed

Affiliation: Institute of Medical Informatics, University of Münster, Albert-Schweitzer-Campus 1, A11, D-48149, Münster, Germany. dugas@uni-muenster.de.

ABSTRACT

Background: Clinical trials apply standards approved by regulatory agencies for Electronic Data Capture (EDC). Operational Data Model (ODM) from Clinical Data Interchange Standards Consortium (CDISC) is commonly used. Electronic Health Record (EHR) systems for patient care predominantly apply HL7 standards, specifically Clinical Document Architecture (CDA). In recent years more and more patient data is processed in electronic form.

Results: An open source reference implementation was designed and implemented to convert forms between ODM and CDA format. There are limitations of this conversion method due to different scope and design of ODM and CDA. Specifically, CDA has a multi-level hierarchical structure and CDA nodes can contain both XML values and XML attributes.

Conclusions: Automated transformation of ODM files to CDA and vice versa is technically feasible in principle.

No MeSH data available.


Related in: MedlinePlus

Example of ODM file. A CRF with 4 itemgroups (IG.1 - IG.4) is presented. Details for item I.1001 are provided such as data type and elaborated text
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Fig1: Example of ODM file. A CRF with 4 itemgroups (IG.1 - IG.4) is presented. Details for item I.1001 are provided such as data type and elaborated text

Mentions: CDISC ODM [7] is an XML-based transport format for both metadata and data in clinical trials. It is applied in many EDC systems, which are accepted for clinical trials by FDA and EMA. Specifically, ODM enables to represent CRFs. A form is structured into item groups. Each item group consists of items. For each item, a data type and an optional code list can be specified. Fig. 1 presents an example of a form in ODM format.Fig. 1


ODM2CDA and CDA2ODM: tools to convert documentation forms between EDC and EHR systems.

Dugas M - BMC Med Inform Decis Mak (2015)

Example of ODM file. A CRF with 4 itemgroups (IG.1 - IG.4) is presented. Details for item I.1001 are provided such as data type and elaborated text
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4494189&req=5

Fig1: Example of ODM file. A CRF with 4 itemgroups (IG.1 - IG.4) is presented. Details for item I.1001 are provided such as data type and elaborated text
Mentions: CDISC ODM [7] is an XML-based transport format for both metadata and data in clinical trials. It is applied in many EDC systems, which are accepted for clinical trials by FDA and EMA. Specifically, ODM enables to represent CRFs. A form is structured into item groups. Each item group consists of items. For each item, a data type and an optional code list can be specified. Fig. 1 presents an example of a form in ODM format.Fig. 1

Bottom Line: An open source reference implementation was designed and implemented to convert forms between ODM and CDA format.There are limitations of this conversion method due to different scope and design of ODM and CDA.Specifically, CDA has a multi-level hierarchical structure and CDA nodes can contain both XML values and XML attributes.

View Article: PubMed Central - PubMed

Affiliation: Institute of Medical Informatics, University of Münster, Albert-Schweitzer-Campus 1, A11, D-48149, Münster, Germany. dugas@uni-muenster.de.

ABSTRACT

Background: Clinical trials apply standards approved by regulatory agencies for Electronic Data Capture (EDC). Operational Data Model (ODM) from Clinical Data Interchange Standards Consortium (CDISC) is commonly used. Electronic Health Record (EHR) systems for patient care predominantly apply HL7 standards, specifically Clinical Document Architecture (CDA). In recent years more and more patient data is processed in electronic form.

Results: An open source reference implementation was designed and implemented to convert forms between ODM and CDA format. There are limitations of this conversion method due to different scope and design of ODM and CDA. Specifically, CDA has a multi-level hierarchical structure and CDA nodes can contain both XML values and XML attributes.

Conclusions: Automated transformation of ODM files to CDA and vice versa is technically feasible in principle.

No MeSH data available.


Related in: MedlinePlus