Can ChatGPT or another voice bot make me a clinical protocol for a clinical investigation with a medical device or DiGA?

We asked ChatGPT.

ChatGPT says (12/2023): "No, ChatGPT cannot create a clinical investigation plan as this is a complex task that requires specific expertise. A clinical investigation plan is a detailed document that describes the process and conduct of a clinical investigation for a medical device or digital health application (DiGA). This requires a precise knowledge of the regulatory requirements according to the MDR 2017 and the Medical Devices Implementation Act as well as a deep understanding of clinical research methods.

Creating a clinical investigation plan usually requires the collaboration of experts such as clinical researchers, physicians, statisticians and other professionals. Consideration of ethical standards, regulatory requirements and scientific methods is critical to conducting a valid and meaningful clinical trial." (individual minor errors have deliberately not been corrected)