Data Standards

Industry Data Standards

SCiAN's CDM team maintains current knowledge of the activities of the Society for Clinical Data Management (SCDM), and the Clinical Data Interchange Standards Consortium (CDISC).

Study Database - eCRF Design: EDCPRO has been developed to meet CDISC's CDASH standard/common data elements for eCRF headers, demographic, adverse events and other safety domains. Therapeutic-area specific (efficacy) forms will be added, as developed.

Study Database - Data Import: EDCPRO utilizes CDISC's ODM data model (snapshot data).

Study Database - Data Export: EDCPRO utilizes CDISC's ODM data model.

Safety (SAE) Database Design: SAEPRO complies with ICH E2B(M) Standards for data upload.

Indication-Specifc Data Standards

In developing oncology-specific (disease history, efficacy, etc.) eCRFs, EDCPRO utilizes the Comond Data Elements (CDE) defined by the National Cancer Institute (NCI).