Source Data Verification (SDV) quality in clinical research: A scoping review

Abstract

Introduction: The value of Source Data Verification (SDV) has been a common theme in the applied Clinical Translational Science literature. Yet, few published assessments of SDV quality exist even though they are needed to design risk-based and reduced monitoring schemes. This review was conducted to identify reports of SDV quality, with a specific focus on accuracy.

Methods: A scoping review was conducted of the SDV and clinical trial monitoring literature to identify articles addressing SDV quality. Articles were systematically screened and summarized in terms of research design, SDV context, and reported measures.

Results: The review found significant heterogeneity in underlying SDV methods, domains of SDV quality measured, the outcomes assessed, and the levels at which they were reported. This variability precluded comparison or pooling of results across the articles. No absolute measures of SDV accuracy were identified.

Conclusions: A definitive and comprehensive characterization of SDV process accuracy was not found. Reducing the SDV without understanding the risk of critical findings going undetected, i.e., SDV sensitivity, is counter to recommendations in Good Clinical Practice and the principles of Quality by Design. Reference estimates (or methods to obtain estimates) of SDV accuracy are needed to confidently design risk-based, reduced SDV processes for clinical studies.

Keywords: Clinical research; Source Data Verification; clinical trial monitoring; quality.

Figure 1.

Visual inspection exercise. © 2020 Highlights for Children, Inc. All rights reserved. Permission to reproduce and distribute this page is granted by Highlights for Children.

Figure 2.

Flow diagram [64]. ACRP = The Association of Clinical Research Professionals; ACT = Applied Clinical Trials; EMBASE = Excerpta Medica database; PsycINFO = American Psychological Association PsycInfo database; SOCRA = The Society of Clinical Research Associates; WoS = Web of Science database.

Figure 3.

Heterogeneity in SDV* quality assessment. Each 3x4 grid in the figure represents SDV quality assessments reported in one included, quantitative article. The SDV methods compared are listed at the bottom of each grid, with NR signifying not reported, extensive signifying high amounts of data values undergone up to 100% SDV, and mixed signifying a combination of two or more SDV methods. *Source Data Verification (SDV): the comparison of study data to their original recording to ensure that, “the reported trial data are accurate, complete, and verifiable from source documents [16].”

Figure 4.

Categorization of review articles. ¹Source Data Verification: the comparison of study data to their original recording to ensure that, “the reported trial data are accurate, complete, and verifiable from source documents [16].”