{"id":23920,"date":"2023-09-08T08:55:03","date_gmt":"2023-09-08T12:55:03","guid":{"rendered":"https:\/\/platohealth.ai\/how-to-structure-a-clinical-investigation-report-cir-summary\/"},"modified":"2023-09-08T16:48:03","modified_gmt":"2023-09-08T20:48:03","slug":"how-to-structure-a-clinical-investigation-report-cir-summary","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/how-to-structure-a-clinical-investigation-report-cir-summary\/","title":{"rendered":"How to Structure a Clinical Investigation Report (CIR) Summary","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"

\"How<\/p>\n

If you\u2019re conducting a clinical investigation of a medical device in an EU Member State, you will be required to submit a clinical investigation report (CIR) along with a summary of the CIR to that Member State.<\/p>\n

<\/p>\n

EU MDR lists this as one of the requirements of a sponsor in Chapter VI, Article 77<\/a> of the regulation. However, EU MDR doesn\u2019t specify the format of the CIR summary. It only notes that, \u201cThe Commission shall issue guidelines regarding the content and structure of the summary of the clinical investigation report.\u201d<\/p>\n

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Well, those guidelines are finally here. The Medical Device Coordination Group released Guidance (2023\/C 163\/06) \u201con the content and structure of the summary of the clinical investigation report<\/a>\u201d in May 2023.<\/p>\n

Here\u2019s what it has to say about what to include in the CIR summary.<\/p>\n

What is a clinical investigation report (CIR) summary?<\/h2>\n

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<\/a> of EU MDR. <\/p>\n

But, as I 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 the summary must be written \u201cin terms and in a format that are easily understandable to the intended user of the medical device.\u201d <\/p>\n

Not only that, but the guidance explicitly encourages brevity and concision in the writing of the summary document, stating that sponsors should \u201cavoid simply copying bodies of text from the full clinical investigation report.\u201d<\/p>\n

In other words, don\u2019t overthink the CIR summary\u2014it really is meant to be a synopsis of the clinical investigation report.<\/p>\n

How should the summary CIR be structured?<\/h4>\n

The MDCG\u2019s guidance<\/a> document breaks the CIR summary into six sections:<\/p>\n

    \n
  1. A cover page<\/li>\n
  2. Title of the clinical investigation – summary information<\/li>\n
  3. Purpose of the clinical investigation<\/li>\n
  4. Description of the investigational device, clinical investigation,<\/li>\n
  5. Results of the investigation<\/li>\n
  6. Conclusion of the clinical investigation<\/li>\n<\/ol>\n

    The cover page will include the title of the clinical investigation, the sponsor, the entity funding the investigation, the ID number<\/a> for the study, and the clinical investigation plan number. <\/p>\n

    The other sections are structured as follows:<\/p>\n

    Title of the clinical investigation – summary information<\/h3>\n

    This section of the CIR summary must include basic, but necessary, information about the study:<\/p>\n