It's all About the Data and MetaData

Need to convert SDTM clinical data to ADaM data? Here's How:

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Introduction

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.

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.  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.

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 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.