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. 2023 May-Jun;22(3):581-584.
doi: 10.1002/pst.2286. Epub 2023 Jan 3.

Just say no to data listings!

Mercidita Navarro  1 , Nancy Brucken  2 , Aiming Yang  3 , Greg Ball  4
Affiliations

Just say no to data listings!

Mercidita Navarro et al. Pharm Stat. 2023 May-Jun.

Abstract

Sponsor companies often create voluminous static listings for Clinical Study Reports (CSRs) and regulatory submissions, and possibly for internal use to review participant-level data. This is likely due to the perception that they are required and/or lack of knowledge of various alternatives. However, there are other ways of viewing clinical study data that can provide an improved user experience, and are made possible by standard data structures such as the Study Data Tabulation Model (SDTM). The purpose of this paper is to explore some alternatives to providing a complete set of static listings and make a case for sponsors to begin considering these alternatives. We will discuss the recommendations from the PHUSE white paper, "Data Listings in Clinical Study Reports."

Keywords: clinical study reports; interactive data listings; static data listings.

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References

REFERENCES

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