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).