Posted by Keith ward on Fri, Oct 30, 2009 @ 03:30 PM
Introduction
If you have you been wondering how you can effectively meet the clinical data study standards set out by the Clinical Data Interchange Standards Consortium (CDISC) specifically with regards to the Study Data Tabulation Module (SDTM) and the Analysis Data Model (ADaM) our data conversion and reporting tool may be the solution you are looking for to generate all of your safety tables and listings and provide supporting documentation in a validated, standardized ADaM compliant manner.
Background
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. Converting your SDTM data to ADaM data, then to submission ready tables and 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.
Solution
ClinPlus has developed an elegant solution for both metadata driven conversion of SDTM data to ADaM data and then producing metadata parameterized driven flexible safety tables and listings from the ADaM data. The metadata, defined in Microsoft Excel spreadsheets becomes the ADaM documentation, therefore eliminating any chance that documentation is not corresponding to the actual process.
Data Conversion
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 data are mapped to 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 is 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.