WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
• Current knowledge is based on practical experience. This paper presents the first novel, quantitative and qualitative view on the efficacy of the sponsor query system widely applied in the pharmaceutical industry, used for quality control purposes by data management for clinical data.
WHAT THIS STUDY ADDS
• This study presents a structured view on the process of clinical data management and sponsor queries, the efficacy and cost effectiveness of sponsor queries and dual data entry and the conclusion to advocate a more evidence-based approach to clinical data validation.
Procedures for verification of data from clinical studies are intended to maintain reliability for clinical trial results. Guidelines or legislations relating to clinical data management are of limited value and no study has yet demonstrated its effectiveness.
Sponsor queries and dual entry procedures from one CRO on three different phase I trials are analysed on content, impact and cost.
In this study, sponsor queries and dual entry procedures proved time and cost inefficient in detecting data discrepancies.
We advocate a more evidence-based approach for enhancing data integrity throughout the process of clinical data management.