Central data monitoring in the multicentre randomised SafeBoosC-III trial - a pragmatic approach.

ABSTRACT:

Background

Data monitoring of clinical trials is a tool aimed at reducing the risks of random errors (e.g. clerical errors) and systematic errors, which include misinterpretation, misunderstandings, and fabrication. Traditional 'good clinical practice data monitoring' with on-site monitors increases trial costs and is time consuming for the local investigators. This paper aims to outline our approach of time-effective central data monitoring for the SafeBoosC-III multicentre randomised clinical trial and present the results from the first three central data monitoring meetings.

Methods

The present approach to central data monitoring was implemented for the SafeBoosC-III trial, a large, pragmatic, multicentre, randomised clinical trial evaluating the benefits and harms of tre

SUBMITTER: Olsen MH 

PROVIDER: S-EPMC8325420 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature