Volume 22, Issue 3 pp. 581-584
VIEWPOINT

Just say no to data listings!

Mercidita Navarro

Mercidita Navarro

Genentech, South San Francisco, California, USA

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Nancy Brucken

Nancy Brucken

IQVIA, Ann Arbor, Michigan, USA

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Aiming Yang

Aiming Yang

Merck & Co., Inc., Rahway, New Jersey, USA

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Greg Ball

Corresponding Author

Greg Ball

Novavax, Gaithersburg, Maryland, USA

Correspondence

Greg Ball, Novavax, Gaithersburg, MD, USA.

Email: [email protected]

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First published: 03 January 2023

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.

DATA AVAILABILITY STATEMENT

Data sharing is not applicable to this article as no new data were created or analyzed in this study.

The full text of this article hosted at iucr.org is unavailable due to technical difficulties.