# Design, implementation and analysis of a quality assurance process for Informed Consents using the DZHK registry TORCH-DZHK1 as an example

## TL;DR

This paper describes a quality assurance process for informed consent forms in clinical trials, showing that most issues can be resolved with systematic review and staff training.

## Contribution

A structured quality assurance concept for informed consents, validated through a large cardiovascular research registry.

## Key findings

- 1,588 out of 2,453 informed consents had at least one quality issue, but 99.8% were resolved.
- Training sessions for study staff helped reduce quality issues and improve awareness of proper documentation.
- Systematic quality control significantly improved the completeness and accuracy of informed consents.

## Abstract

To collect sensitive patient data during clinical trials, the Informed Consent (IC) of the participants must be obtained beforehand. If the IC is not correct and complete, the document cannot be used to represent the will of the participant and will not be considered a legally valid document. However, few studies have examined the quality of the IC and the IC-quality found is unfortunately not satisfactory. The aim of this article is to describe the development of an IC quality assurance concept and to report the results of an evaluation using the example of a German Centre for Cardiovascular Research (DZHK) registry. All quality issues identified during the study were documented. These were aggregated into the quality indicators “Completeness”, “Consistency of Data”, “Correctness” and “Validity”. Of 2,453 ICs, 1,588 had at least one quality issue; 99.8% of them were resolved. In addition, training sessions were conducted with study staff to raise awareness of the importance of correct IC collection, including documentation, and to minimize quality issues. Our data exemplify that improvements in the recording of ICs by the study staff can be achieved. This evaluation shows the value and importance of continuous IC quality control.

In clinical research, informed consent is essential to ensure that participants voluntarily agree to the use of their personal and medical data. Only when consent forms are complete and accurate can they truly reflect a participant’s decision and meet legal requirements. Despite its importance, the overall quality of informed consent documentation has rarely been studied and is often found to be insufficient. In this work, we describe the development of a structured approach to improve and monitor the quality of informed consent forms using a large cardiovascular research registry in Germany as an example. By systematically reviewing consent documents, we were able to identify common problems, such as missing information, inconsistencies, or invalid entries. Importantly, nearly all identified issues could be successfully corrected. In addition, targeted training sessions were provided to study staff to increase awareness of the importance of proper consent documentation and to prevent future errors.

Our findings show that informed consent quality can be substantially improved through continuous quality control and education. This approach helps protect the rights of study participants, strengthens the legal reliability of consent documents, and supports the overall integrity of clinical research.