Just say no to data listings!
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.”
CONFLICT OF INTEREST
The authors declare that they have no competing interests.
Open Research
DATA AVAILABILITY STATEMENT
Data sharing is not applicable to this article as no new data were created or analyzed in this study.