Developing Project-Specific Consent Documents: A Registered Report for a Multistep Approach Using LLMs

Abstract

Within the scope of clinical trials, developing participant information sheets and informed consent forms is a complex task that demands clarity, precision, and compliance with regulatory standards. Developing these documents is crucial for ensuring that participants are fully informed about the research in which they are involved. However, the process is often time-consuming and resource-intensive. In this context, we present the development of a methodology enabling the use of Large Language Models to assist in the creation of information sheets and informed consent forms for clinical trials according to a predesigned template. This research is being conducted within the framework of the project REPO4EU (Precision drug REPurpOsing For EUrope and the world).

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