CDISC ODM OPEN Development Conference September 17-19, 2008 Phoebe Whitefield Senior Systems Analyst

9/17/08 CDISC ODM 2 CDISC ODM.. Clinical Data Interchange Standards Consortium – Operational Data Model (CDISC-ODM) Standard for interchange of clinical trial data Handles –study meta data –study administrative data –study clinical data

9/17/08 CDISC ODM 3 CDISC ODM Terms An item is an individual clinical data item. –Ex. systolic blood pressure, Date Informed Consent Signed An item group is a closely related set of items that are generally analyzed together. A form is analogous to a page in a paper CRF book or electronic CRF screen. A study event is a reusable package of forms usually corresponding to a study data-collection event. A subject is a patient participating in the study.

9/17/08 CDISC ODM 4 ODM XSD Metadata Diagram

9/17/08 CDISC ODM 5 ODM XSD Clinical Data Diagram

9/17/08 CDISC ODM 6 ODM XSD/Study Metadata Mapping ODM Metadata ElementStudy Protocol Number GlobalVariables.StudyNameProtocol Number GlobalVariables.StudyDescriptionProtocol Title MetaDataVersion.StudyEventDefStudy Event MetaDataVersion.FormDefForm MetaDataVersion.ItemGroupDefModule MetaDataVersion.ItemDefQuestion MetaDataVersion.CodeListQuestion’s valid values

9/17/08 CDISC ODM 7 Study Form E1505

9/17/08 CDISC ODM 8 Study Form Translated Into ODM Metadata

9/17/08 CDISC ODM 9 ODM XSD/Study Data Mapping ODM Clinical ElementStudy Data AdminData.UserAdministrative user for this study event. AdminData.LocationLocation of the user or the sites associated with this study event. ClinicalData.SubjectDataKey information for a subject data (patient). ClinicalData.FormDataStudy Form data ClinicalData.ItemGroupDataModules data ClinicalData.ItemDataQuestion data.

9/17/08 CDISC ODM 10 Fill In Study Data Using OPEN

9/17/08 CDISC ODM 11 Study Data Translated Into ODM

9/17/08 CDISC ODM 12 RandoNode Metadata Classes

9/17/08 CDISC ODM 13 RandoNode ClinicalData Classes