Clinical Trials: SDTM and ADaM

The CDISC CDASH standard for collection and common nomenclature for clinical trials data, the Study Data Tabulation (SDTM), and Analysis Data (ADaM) models are the accepted standards for clinical trials data. Summit Analytical are experts in the efficient development and validation of CDISC compliant, fully documented, submission ready, SDTM and ADaM datasets. As part of our Regulatory Data Standards and Compliance services for each study we will provide our clients with submission ready:

  • SDTM specifications and Annotated CRF

  • SDTM domains

  • SDTM Define.xml and Study Data Reviewer’s Guide (SDRG)

  • ADaM specifications

  • ADaM datasets, linked to the planned analyses

  • ADaM Define.xml and Analysis Data Reviewer’s Guide (ADRG)