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 whi

SUBMITTER: Hamidi M 

PROVIDER: S-EPMC11639101 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature