CDISC - A Brief Overview

CDISC is the acronym for 'Clinical Data Interchange Standards Consortium'. It is a non-profit 'Standards Developing Organization' (SDO) that strives to develop global standards which aid the varied aspects of clinical or medical data.

CDISC has developed various standards to support medical research right from protocol to the final reporting of results for clinical trials.

Some of the standards are listed below:

• Study Data Tabulation Model (SDTM) - The recommended standard for FDA submissions of Clinical Trial data.

• Standard for Exchange of Non-Clinical Data (SEND) - The recommended standard for submissions of Non-Clinical (animal testing) data.

• Analysis Data Model (ADaM) - The recommended standard for data submissions with FDA and PMDA which supports Statistical Analysis and Trace-ability.

• Case Report Tabulation Data Definition Specification (CRT-DDS) - Commonly referred to as the 'define.xml', a mandatory machine readable version of the submission data.

• Clinical Data Acquisition Standards Harmonization (CDASH) - A recommended standard guideline to aid in the development and standardization of data collection.

• CDISC Terminology - Recommended value lists of controlled terms (Extensible Lists and Non Extensible Lists) for the harmonization of data collected across submissions.

CDISC SHARE (Shared Health and Clinical Research Electronic Library) is a metadata repository to further assist and encourage usage of CDISC standards in human and machine-readable formats.

SHARE helps users find, use and understand metadata for clinical studies in a more efficient way as it improves data trace-ability right from protocol to the final analysis. SHARE is a step to seek a collaborative environment to help further development of the CDISC standards while improving quality and further adoption of the same.

At Citus Consulting we assist our clients adopt CDISC standards and provide quality inputs at each development stage to help fast-track SDTM submissions.