CDISC

The basic standard in drug development

Clinical Data Interchange Standards Consortium (CDISC)

As the CDISC states about itself ( https://www.cdisc.org ):

“CDISC creates clarity in clinical research by bringing together a global community of experts to develop and advance data standards of the highest quality. Together, we enable the accessibility, interoperability, and reusability of data for more meaningful and efficient research that has greater impact on global health.”

The roots goes back to 1997 – when Planimeter was also established – when a branch of volunteers started to set-up standards for clinical study data databases, variable names, formats. The CDISC Consorcium is already part of the history of drug development.

During our evaluation, reporting activities we also apply and follow the CDISC terminologies and rules. 

 

CDASH

“CDASH establishes a standard way to collect data consistently across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM), delivering more transparency to regulators and others who conduct data review.” 

(Source: https://www.cdisc.org/standards/foundational/cdash )

SDTM

“SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. Implementing SDTM supports data aggregation and warehousing; fosters mining and reuse; facilitates sharing; helps perform due diligence and other important data review activities; and improves the regulatory review and approval process. SDTM is also used in non-clinical data (SEND), medical devices and pharmacogenomics/genetics studies.

SDTM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan).

Details on the requirements for FDA are specified in the FDA’s Data Standards Catalog for NDA, ANDA, and certain BLA submissions. For more information, please visit the FDA Guidance on Standardized Data.

Details on the requirements for PMDA can be found on the Advanced Review with Electronic Data Promotion Group page.”

(Source: https://www.cdisc.org/standards/foundational/sdtm ).

ADaM

ADaM defines dataset and metadata standards that support:

  • efficient generation, replication, and review of clinical trial statistical analyses, and
  • traceability among analysis results, analysis data, and data represented in the Study Data Tabulation Model (SDTM).​

ADaM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan).

Details on the requirements for FDA are specified in the FDA’s Data Standards Catalog for NDA, ANDA, and certain BLA submissions. For more information, please visit the FDA Guidance on Standardized Data.   

Details on the requirements for PMDA can be found on the Advanced Review with Electronic Data Promotion Group page.

(Source: https://www.cdisc.org/standards/foundational/adam  )