Clinical Data Interchange Standards Consortium

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The Clinical Data Interchange Standards Consortium (short CDISC ) is a non-profit organization ( Charitable Society ), headquartered in Austin in the US state of Texas .

CDISC is developing a number of open standards for sharing clinical trial data . CDISC is a US Food and Drug Administration (FDA) accepted standard for submitting clinical data for drug approval . XML schemas are used to define the standards . Alternatively, a DTD is available.

CDISC standards

  • The Study Data Tabulation Model (SDTM) describes the content structure of tables in which the case reports from clinical studies documented in individual Case Report Forms can be summarized and submitted to the FDA.
  • The Standard for the Exchange of Non-Clinical Data (SEND) is used, similar to SDTM, for submitting non-clinical data to the FDA.
  • The Operational Data Model (ODM) is a standard with several functions. On the one hand, it allows the specification of metadata, i.e. the forms, questions and data formats that are used in a study. Second, it can display entered data in two ways: just the latest data (snapshot), or any data entry and change (transactional). The snapshot format is the preferred transport standard. So z. B. Migrate studies between different systems. The transactional format, on the other hand, is mostly used to archive data.
  • Dataset XML is a standard for transporting table data. It is intended to replace the proprietary and outdated transport format SAS V5 and is to be approved for submission to the FDA in the future. It is particularly suitable for transporting data in SDTM format, but can also contain generic table data.
  • The Laboratory Data Model (LAB) is used to exchange clinical laboratory data between laboratories and pharmaceutical companies. The standard can be implemented in various formats, such as XML , ASCII , SAS or HL7 V3.
  • The Clinical Data Acquisition Standards Harmonization (CDASH) describes the content structure of clinical databases, which are intended to record the subject data from the Case Report Forms. The 18 predefined domains are structured in such a way that a transformation into SDTM is as easy as possible.
  • Using the Analysis Dataset Model (ADaM) , the statistical methods used to evaluate the clinical data can be documented. The aim is to enable the agency to reproduce the statistical analyzes carried out by the pharmaceutical company.
  • The Case Report Tabulation (CRT) is a specification of the data definition (Define.xml). This defines how metadata can be submitted using the ODM transport standard .
  • The Structured Clinical Trial Protocol (SCTP) is a draft for a model that is intended to enable the exchange of protocol data between computer systems and those involved. In terms of content, SCTP is based on SDTM.

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