{"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":"
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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
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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 FREE RESOURCE: <\/strong>Click here<\/span> to download our 15-in-1 clinical investigations content bundle to help you run studies and collect clinical data more efficiently.<\/a><\/p>\n 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 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 The MDCG\u2019s guidance<\/a> document breaks the CIR summary into six sections:<\/p>\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 This section of the CIR summary must include basic, but necessary, information about the study:<\/p>\n Here, you\u2019ll briefly explain the hypothesis\/hypotheses and purpose for your clinical investigation. Include some basic background information about the device that\u2019s being studied and the condition it\u2019s treating. <\/p>\n 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 \u201cwhy\u201d behind your clinical investigation. What\u2019s 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?<\/p>\n 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:<\/p>\n It\u2019s 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.<\/p>\n This is the section where you summarize the outcomes of your clinical investigation. The guidance states that this should include:<\/p>\n Finally, you\u2019ll 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.<\/p>\n This section will include brief answers to the questions:<\/p>\n And that\u2019s it! <\/p>\n I\u2019d encourage you to read the guidance yourself to get the full picture of the structure for your CIR summary, but if you\u2019ve made it through this article beforehand, you shouldn\u2019t feel overwhelmed by the guidance document itself. <\/p>\n FREE RESOURCE: <\/strong>Click here<\/span> to download our 15-in-1 clinical investigations content bundle to help you run studies and collect clinical data more efficiently.<\/a><\/p>\n The one thing you shouldn\u2019t have to worry about as you write up your CIR summary is the quality of the data you\u2019ve obtained from your clinical investigation. With so much riding on your clinical data, it\u2019s crucial you have an electronic data capture (EDC) solution<\/a> that\u2019s built for your study\u2019s needs. <\/p>\n That\u2019s why we built SMART-TRIAL by Greenlight Guru<\/a> specifically for MedTech. We knew the industry needed a tool that would allow MedTech companies to collect clinical evidence and safety and performance data\u2014for any activity throughout the entire medical device lifecycle.<\/p>\n Our software comes pre-validated for both FDA and ISO 14155:2020 requirements to ensure you\u2019re in compliance from the very beginning of your clinical investigation.<\/p>\n If you\u2019re ready to see how a MedTech-specific clinical data solution can streamline your clinical investigation, then get your free demo of SMART-TRIAL by Greenlight Guru<\/a>!<\/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","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":23923,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[52],"tags":[],"acf":[],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/23920"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/comments?post=23920"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/23920\/revisions"}],"predecessor-version":[{"id":23922,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/23920\/revisions\/23922"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/23923"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=23920"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=23920"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=23920"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}What is a clinical investigation report (CIR) summary?<\/h2>\n
How should the summary CIR be structured?<\/h4>\n
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Title of the clinical investigation – summary information<\/h3>\n
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Purpose of the clinical investigation<\/h3>\n
Description of the investigational device, clinical investigation, and methods used<\/h3>\n
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Results of the investigation<\/h3>\n
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Conclusion of the clinical investigation<\/h3>\n
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SMART-TRIAL by Greenlight Guru makes collecting clinical data a breeze<\/h2>\n
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