SDTM

Concept

Preparation of SDTM domains is quite a well defined procedure, which primarily means the proper application of the guidance in case of the standard variables and domains (e.g. sex, age or blood pressure). Due to the nature of SDTM even the study or therapeutic area specific variables can easily been transformed into SDTM-compliant variables with following the naming and formatting conventions.

Our solution

  • Creation of Data Standards Library including a CRF Library, and CDASH/SDTM/ADaM Libraries
  • Set-up Study Specific aggregates mapping visit information into the appropriate visit window structure
  • Development of a metadata repository to enable data model compliance checking and define.xml generation
  • Comparison against Study Specifications
  • Validation against the Data Standards Library
  • Generation of pooled analysis based on CDISC data (for ISS or ISE purposes)
  • Creation of macros for ADaM dataset creation.

As SDTM is a living concept in itself , we pay great attention to its own development: we intensively follow the achievements regarding development of Therapeutic Area Data Standards (TAUGs), Metadata Submission Guidelines (MSG) or SDTM implementation Guide for medical devices (SDTMIG-MD).

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