Tuesday, July 21, 2009

SDTM, ADaM Domain Datasets Generation

With the latest release of the updated CDISC SDTM and ADaM standards, most of the members of the Pharma industry are all in common talking the same issues. How and when does the creation of SDTM files occur during the clinical trial process? What files should be used to create analysis files? How do I keep track of all of the data transformations? The possible services listed below will offer some solution and considerations on how to implement CDISC standards within a pharmaceutical organization with respect to domain datasets generation which are submitted to FDA. A discussion of the types of software solutions that can be used to perform the transformation of data into the SDTM is worth gaining an insight

For most submission, both the CRF data and the analysis datasets are submitted to the FDA as part of a new drug application. Now that the CDISC standards have been developed and endorsed by the FDA, many companies are reengineering their internal processes to adopt them. As complex as the development of the standards was, the implementation will prove to be equally as complex. This paper will discuss some of the issues to consider when implementing both the SDTM and ADaM standards. Suggestions presented here should be considered as such since each organization must develop an implementation roadmap that best fits their environment.

Possible SDTM, ADaM Domain Datasets Generation Services
  • Complete CDISC SDTM and Lab Terminology implementation
  • In-built functions for combining data
  • Domain and variable properties editing
  • Mappings on test clinical data testing
  • Transformation code generation
  • Execution of transformation code on clinical data
  • Creating SQL statements to ensure creation an SDTM database
  • Populating SDTM database with created SDTM records in a organized way


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