SERVICES

CDISC

Westat’s experience with implementing the Clinical Data Interchange Standards Consortium (CDISC) standards began over 10 years ago. We have the expertise to transform your data into a submission-ready format.

What is CDISC, and when is it required?

Westat has experience implementing the CDISC standards required for data management, programming, documentation, and eCTD data submission, on both current and legacy clinical trials.

CDISC stands for Clinical Data Interchange Standards Consortium, a not-for-profit global organization that has developed and published data standards for the pharmaceutical industry for over 20 years. According to the CDISC.org website, CDISC standards are recognized and required by regulatory agencies (US FDA and Japan PMDA) around the world. Their goals are increased quality and greater efficiency, leading to scientific breakthroughs that will have an invaluable impact on clinical research and global health.

cdisc Clear Data. Clear Impact. Proud Member

We take your data from the collection point to the final submission, while efficiently and expertly adhering to the CDISC standards!

CDASH

Clinical Data Acquisition
Standards Harmonization

CDASH – compliant
CRF Design
CDASH – compliant
Database
CDASH – compliance
Edit Checks
Controlled Terminology

SDTM

Study Data
Tabulation Model

Proprietary
programming library
Pinnacle 21 Validation
Compliance
Study Data
Reviewer’s Guide
Define.xml for SDTM
SDTM aCRFs
Controlled Terminology

ADaM

Analysis
Data Model

Proprietary
programming library
Pinnacle 21 Validation
Compliance
Analysis Data
Reviewer’s Guide
Define.xml for ADaM
Controlled Terminology

The key components of a CDISC data submission package are:

CDASH – compliant data collection forms and database
SDTM – compliant data sets, that represent the data as it was collected
ADaM – compliant data sets, which contain analysis data
Controlled Terminology, which consists of standardized code lists applied throughout the CDISC data package
Supporting Documentation, which includes reviewer’s guides, annotated data collection forms, and a complex metadata file called Define.xml

Westat has the tools and experience to apply each of these components to your project and improve yourchances for a successful submission.