Development, Involvement and Use of an Overarching In-House Registry for Clinical Trials

Abstract

Introduction: Conducting clinical studies is an integral part of the clinical research repertoire of university hospitals. A wealth of organizational competences must always be available in a central location and in an up-to-date form for appropriate administration. Information such as the number of ongoing studies, and the number of enrolled participants is required for tasks related to e.g. sponsor quality management and KPIs. A registry for clinical trials can answer these questions and enhance the exchange of information.

Methods: Requirements for an in-house registry for clinical trials were defined in a multidisciplinary task force. The requirements included interfaces and key abilities to create customized reports to fulfill the obligation to provide evidence.

Results: The study registry is productive since May 2020 and internal interfaces have been implemented to ensure consistency between systems and the documented studies. Manually recorded data is enhanced by interfaces to primary registers. The comprehensive data set in the study register enables the creation of individual queries at any time for a variety of questions.

Discussion: The UKSH study register has already demonstrated its usefulness in various applications and several projects. The extensive data set and the modular realization allows many current and future requirements to be met.

Keywords: Clinical Study; Clinical Trial; Health Information System; Registries.