Clinical Data Interchange Standards Consortium (CDISC)
The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit group that defines clinical data standards for the pharmaceutical industry. CDISC has developed numerous data models that you should familiarize yourself with. Four of these models are of particular importance:
Study Data Tabulation Model (SDTM).
The SDTM defines the data tabulation data sets that are to be sent to the FDA as part of a regulatory submission. The FDA has endorsed the SDTM in its Electronic Common Technical Document (eCTD) guidance. The SDTM was originally designed to simplify the production of case report tabulations (CRTs), and therefore the SDTM is listingfriendly, but not necessarily friendly for creating statistical summaries and analysis.
Analysis Dataset Models (ADaM).
The CDISC ADaM team defines data set definition guidance for the analysis data structures. These data sets are designed for creating statistical summaries and analysis.
Operational Data Model (ODM).
The ODM is a powerful XML-based data model that allows for XML-based transmission of any data involved in the conduct of clinical trials. SAS has provided support for importing and exporting ODM files via the CDISC procedure and the XML LIBNAME engine.
Case Report Tabulation Data Definition Specification (Define.xml).
Define.xml is the upcoming replacement for the data definition file (define.pdf) sent to the FDA with electronic submissions. Define.xml is based on the CDISC ODM model and is intended to provide a machine-readable version of define.pdf. Because define.xml is machine readable, the metadata about the submission data sets can be easily read by computer applications. This allows the FDA to work more easily with the data submitted to it.
You will be exporting, importing, and creating data for these models, so it is important that you learn about them. The FDA has formally endorsed the use of these data models in their guidance. Eventually the FDA will probably require data to be formatted to the CDISC model standards for regulatory submissions.
Wondering how you can effectively meet the clinical data study standards set out by the Clinical Data Interchange Standards Consortium (CDISC), specifically regarding the Study Data Tabulation Module (in a process also known as SDTM mapping) and the Analysis Data Model (ADaM)? Then our data conversion and reporting tool may be the solution for which you’ve been looking. Imagine being able to generate all of your safety tables and listings, and provide supporting documentation in a validated, standardized ADaM-compliant manner. Now you can.
Adhering to CDISC standards has proven to facilitate efficient data integration and transport, as well as access and review. Ideally, FDA Reviewers will want to perform analytic review using ADaM standards. However, converting your SDTM mapping data to ADaM data, to submission-ready tables, and then accurately documenting the process can present numerous challenges.
One of the primary challenges is providing complete documentation of the creation of the tables and listings, and the underlying ADaM data sets, the process by which each variable in the ADaM is traced back to its original source. CDISC specifications indicate that any variables copied or derived from an SDTM domain into an ADaM data set must retain the integrity of the data in the SDTM domain.
The ClinPlus Solution
ClinPlus has developed an elegant solution for metadata driven conversion of SDTM mapping data to ADaM data, and then produces metadata parameterized- driven flexible safety tables and listings from the ADaM data. The metadata defined in Microsoft Excel spreadsheets becomes the ADaM documentation, thereby eliminating any chance that documentation might not correspond to the actual process.
The first step is to convert your SDTM data to your ADaM data using the ClinPlus Data Converter Method. The ClinPlus Data Converter Method is controlled by metadata stored in Microsoft Excel spreadsheets that define how SDTM mapping data are written into ADaM data structures in an Excel worksheet for each data domain. A data conversion rule is specified for each variable. These conversion rules are written using Base SAS programming syntax that is submitted to SAS during the conversion process. A cross-reference to Statistical Analysis Plan documents the rational for each conversion or derivation. This method provides clean, exact documentation of the process, as well as simple maintenance and versioning. This approach not only documents a complicated process, but maintains the data integrity between the SDTM and ADaM data sets, thus meeting CDISC specifications.