What is CDISC?

Clinical data that is submitted to the FDA and PMDA is required to be in CDISC format.

CDISC (Clinical Data Interchange Standards Consortium) is a not-for-profit SDO (Standards Development Organization) that develops data standards for clinical research.

FDA & PMDA Required CDISC Standards

The US FDA (Food and Drug Administration) and Japanese PMDA (Pharmaceuticals and Medical Devices Agency) require the following CDISC standards:

• SDTM (reporting)
• ADaM (analysis)
• SEND (pre-clinical)
• Define-XML (metadata)
• CDISC Controlled Terminology (semantics)

CDISC data submissions are to be performed, documented and validated according to the regulator’s technical conformance guide and validation/business rules that are available at:

• FDA: Study Data Standards Resources
• PMDA: New Drug Review with Electronic Data

Other CDISC Standards

CDISC has other standards that aim to cover the entire clinical data lifecycle including:

• CDASH (data collection)
• QRS (questionnaires, QOL, PRO, etc.)
• ODM (data exchange)
• Therapeutic Area user guides
• PRM (protocol development)
• Lab Data Model

Next Steps

ClinBuild also has introductions to the following CDISC standards:

• CDASH

Contact

If you require more information or CDISC consultancy services please contact on info@clinbuild.com or +49 176 578 16593.