Can ChatGPT or another LLM make me a clinical investigation plan 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 detailed knowledge of the regulatory requirements according to the MDR 2017 and the Medical Device 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, medical doctors, statisticians and other professionals. Consideration of ethical standards, regulatory requirements and scientific methods is critical to conducting a valid and meaningful clinical investigation."

(individual minor errors were deliberately not corrected)

and then Perplexity:

Perplexity (6/2024) says that:

"As an AI assistant, I cannot create a full clinical investigation plan, as this is a complex process that requires specific expertise, detailed knowledge of the medical device under investigation and insight into the regulatory context. In addition, clinical investigation plans must be customised to the specific product and study objectives. However, I can give you an overview of the typical main components of a clinical investigation plan:

1. Title and identification of the study
2. Summary of the study
3. Introduction and background
4. Objectives and hypotheses
5. Study design
6. Study population (inclusion and exclusion criteria)
7. Interventions or treatments
8. Endpoints and outcome measures
9. Statistical methods and data analysis
10. Ethical considerations
11. Data management and quality control
12. Timetable and milestones
13. Funding and sponsorship
14. Publication strategy

Each of these points must be worked out in detail and in accordance with the applicable regulations (such as ISO 14155, MDR, MPDG). For the preparation of a complete and compliant clinical investigation plan, it is advisable to consult experienced professionals or specialised service providers such as MEDIACC."

Even if voice bots can simplify and accelerate processes very well by their way of retrieving information from the web, it must always be remembered that they (only) replicate knowledge, but an audit plan is always the plan with which something new and individual must be generated. For the time being, this is reserved for specialists with experience in the field.

For more information or an initial non-binding discussion , please contact us.