This document is intended to provide Commission guidance for the content and structure of the summary of the clinical investigation report. This ensures that the summary of the clinical investigation report presents information about the design, conduct, analysis, and results of the clinical investigation in terms and in a format that are easily understandable to the intended user of the medical device.
In this article, the main structure of the summary of the clinical investigation report will be presented. For further details of the requirements, please consult the attachment.
1. Cover page, including date of summary, title of clinical investigation, name and contact details of the entity sponsoring the study, name of the entity funding the study, single identification number, and clinical investigation plan number.
2. Title of the clinical investigation – summary information, including brief study title, full study title, dates of investigation, location(s), and reason for temporary halt or early termination if relevant.
- 3. Purpose of the clinical investigation
- 4. Description of the investigational device, clinical investigation, and methods used, including description of participants, description of the device and comparator, description of procedures to use the device, study design, objectives and endpoints, sample size, randomisation and blinding, follow up duration, concomitant treatments, statistical analysis methods, and substantial modifications.
- 5. Results of the investigation, including participant flow, baseline demographic and clinical characteristics, outcome of the intervention, safety outcomes, and deviations from the clinical investigation plan.
- 6. Conclusion of the clinical investigation, including what the results mean, what do the results add to the current scientific knowledge, limitations, and potential for future studies.
Commission Guidance on the content and structure of the summary of the clinical investigation report