Overview
Publication
BMC Med Res Methodol. 2023 Jun 24; 23(1):147.
PubMed ID: 37355583
Title
Data quality in an HIV vaccine efficacy clinical trial in South Africa: Through natural disasters and with discipline
Authors
Laher F, Malahleha M, Ramirez S, Brumskine W, Otwombe K, Moodie Z, Allen M
Abstract
To produce quality data that informs valid clinical trial results and withstands regulatory inspection, trial sites should adhere to many complex and dynamic requirements. Understanding non-conformance to requirements informs the emerging field of improvement science. We describe protocol deviations in South Africa's largest HIV vaccine efficacy trial.
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