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).