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

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Olsen M. H., Hansen M. L., Safi S., Jakobsen J. C., Greisen G., Gluud C.

BMC MEDICAL RESEARCH METHODOLOGY, vol.21, no.1, 2021 (SCI-Expanded) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 21 Issue: 1
  • Publication Date: 2021
  • Doi Number: 10.1186/s12874-021-01344-4
  • Journal Name: BMC MEDICAL RESEARCH METHODOLOGY
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, CINAHL, EMBASE, MEDLINE, Directory of Open Access Journals
  • Keywords: Central monitoring, Data quality, Data deviations, Missing data, Clinical trials, Mahalanobis distance, DATA QUALITY, CLINICAL-TRIALS, IMPACT
  • Gazi University Affiliated: Yes

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.