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Stephanie Hinton

Health Care

How to Structure a Clinical Investigation Report Summary

European Union Medical Device Regulation provides guidance

Published: Tuesday, October 10, 2023 - 11:03

If you’re conducting a clinical investigation of a medical device in a European Union member state, you will be required to submit a clinical investigation report (CIR) along with a summary of the CIR to that member state.

The European Union Medical Device Regulation (EU MDR) lists this as one of the requirements of a sponsor in Chapter VI, Article 77 of the regulation. However, EU MDR doesn’t specify the format of the CIR summary. It only notes that, “The Commission shall issue guidelines regarding the content and structure of the summary of the clinical investigation report.”

Well, those guidelines are finally here.

The EU Medical Device Coordination Group released guidance (2023/C 163/06) “on the content and structure of the summary of the clinical investigation report” in May 2023.

Here’s the guidance on what to include in the CIR summary.

What is a CIR summary?

The clinical investigation report contains a detailed description of the study, the results of the investigation (including any adverse events), and a discussion of the overall conclusions. A full list of what must be included can be found in Annex XV, Chapter III of the EU MDR.

But, as noted earlier, the CIR must also be submitted with a summary. While the CIR summary will provide much of the same information, the guidance states that it must be written “in terms and in a format that are easily understandable to the intended user of the medical device.”

Not only that, but the guidance explicitly encourages brevity and concision when writing the summary document, stating that sponsors should “avoid simply copying bodies of text from the full clinical investigation report.”

In other words, don’t overthink the CIR summary; it really is meant to be a synopsis of the clinical investigation report.

How should the summary CIR be structured?

The MDCG’s guidance document breaks the CIR summary into six sections:
• A cover page
• Title of the clinical investigation—summary information
• Purpose of the clinical investigation
• Description of the investigational device, clinical investigation
• Results of the investigation
• Conclusion of the clinical investigation

The cover page will include the title of the clinical investigation, the sponsor, the entity funding the investigation, the ID number for the study, and the clinical investigation plan number.

The other sections are structured as follows:
• Title of the clinical investigation—summary information. This section of the CIR summary must include basic, but necessary, information about the study.
• Brief study title
• Full study title
• Dates of the investigation
• Location(s)
• The reason for a temporary halt or early termination (if this applies to your study)

Purpose of the clinical investigation

Here, you’ll briefly explain the hypothesis/hypotheses and purpose of your clinical investigation. Include basic background information about the device that’s being studied and the condition it’s treating.

You may also need to describe the current standard of care for the condition and other possible interventions that could be used. You can think of this as the “why” behind your clinical investigation. What’s unique about your device? How could it potentially change current barriers of care for a given patient? In other words, why is your device necessary?

Description of the investigational device, clinical investigation, and methods used

In this section of the CIR summary, you will be summarizing everything that went into the conduct of the clinical investigation, such as descriptions of:
• The participants
• The device and any comparator
• Study design
• Objectives and endpoints
• Sample size
• Enrollment site(s)
• Any randomization and blinding used
• Follow-up duration
• Concomitant treatments
• The statistical analysis methods
• Any substantial modifications to the original clinical investigation plan

It’s important to note that this is not the place to include results, analysis, conclusions, or discussion points. This is simply a concise description of the clinical investigation that was conducted.

Results of the investigation

This is the section where you summarize the outcomes of your clinical investigation. The guidance states that this should include:
• Participant flow, meaning the number of patients screened, enrolled, allocated, and followed up with for each intervention. (The guidance provides a sample flowchart and strongly recommends you use it, or a similar flowchart.)
• The baseline demographic and clinical characteristics of participants
• Outcomes of the interventions
• Safety outcomes, such as adverse events and any subject withdrawals
• Deviations from clinical investigation plan
• Conclusion of the clinical investigation

Finally, you’ll use the last section of your CIR summary to discuss the results of your clinical investigation. Remember to keep this brief and clear, per the instructions at the beginning of the guidance.

This section will include brief answers to the questions:
• What do the results of your clinical investigation mean?
• What do the results add to current scientific knowledge?
• Are there any limitations to your investigation, such as biases, uncertainties, or limitations in acceptability of the results in real-world situations?
• What is the potential for future studies, if any?

And that’s it!

I’d encourage you to read the guidance yourself to get the full picture of the structure for your CIR summary. But if you’ve made it through this article beforehand, you shouldn’t feel overwhelmed by the guidance document itself.

Published Sept. 8, 2023, on the Greenlight Guru blog.


About The Author

Stephanie Hinton’s picture

Stephanie Hinton

Stephanie Hinton is a clinical medical device guru with more than a decade of combined experience working in human subjects research. Her expertise includes recruitment strategy, protocol development, IRB submissions and amendments, and preparing for NIH grant applications, as well as coordinating and planning for DSMB meetings.