• Corpus ID: 13865815

Planning to Pool SDTM by Creating and Maintaining a Sponsor-Specific Controlled Terminology Database

@inproceedings{Kramer2017PlanningTP,
  title={Planning to Pool SDTM by Creating and Maintaining a Sponsor-Specific Controlled Terminology Database},
  author={Corinne Kramer and R. Hari and Keith Shusterman and Chiltern},
  year={2017}
}
When SDTM data are consistently standardized, data can be easily pooled across studies. To consistently standardize raw data to SDTM across studies, there must be an assigned place for each collection field and each collection field must be in its assigned place. Following the SDTM Implementation Guide and applying Controlled Terminology (CT) as specified is sufficient to support fairly consistent SDTM mapping across studies. To enhance the consistency, sponsor guidelines must be established… 

Tables from this paper

References

ADaM or SDTM? A Comparison of Pooling Strategies for Integrated Analyses in the Age of CDISC
TLDR
This paper compares the two approaches on the basis of actual experiences with submissions in two companies following the two different strategies for pooling strategies of single study data possible for an integrated analysis.