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It explains what information NICE requires and the format in which it should be presented.\nInformation should be submitted in the \u0013 HYPERLINK \"https://www.nice.org.uk/what-nice-does/our-guidance/about-technology-appraisal-guidance/technology-appraisal-submission-templates-and-supporting-documents\" \u0014single technology appraisal company evidence submission template\u0015. Companies making evidence submissions to NICE should also refer to the \u0013 HYPERLINK \"https://www.nice.org.uk/process/pmg36/chapter/introduction-to-health-technology-evaluation\" \u0014NICE health technology evaluations manual\u0015, which gives further details of procedures and methods relating to single technology appraisal and highly specialised technologies evaluation submissions.\nThe submission should be as brief and informative as possible. The main body of the submission must not be longer than 150 pages, excluding the appendices and the pages covered by the template.\nThe submission should be sent to NICE electronically in Word or a compatible format, and not as a PDF file. The submission must be a standalone document. Some of the information we request should be submitted as appendices to the main submission (when this is the case, it is clearly marked). The information in these appendices is required by the external assessment group (EAG) to fully critique the submission. The appendices are not normally presented to the evaluation committee, but will be available to them on request.\nWhen making an evidence submission, companies must ensure that:\nAll confidential information is highlighted and underlined in the electronic version sent to NICE.\nAn executable electronic copy of the economic model is included in the version sent to NICE, with full access to the programming code. The content of the evidence submission and the content of the economic model should match.\nThe checklist of confidential information (provided by NICE with the invitation to submit) is completed and submitted.\nSee section 5.3 and 5.4 of \u0013 HYPERLINK \"https://www.nice.org.uk/process/pmg36/chapter/introduction-to-health-technology-evaluation\" \u0014NICE’s health technology evaluations manual\u0015 for information about all aspects of information handling.\nTo ensure that the evaluation process is as transparent as possible, NICE considers that evidence on which the evaluation committee’s decisions are based should be publicly available.\nNICE requires the medical director of the company to sign a statement confirming that all clinical trial data necessary to address the remit and scope of the technology evaluation as issued by the Department of Health and Social Care and NICE, within the company's or any of its associated companies’ possession, custody, or control in the UK, or elsewhere in the world, have been disclosed.\nNICE considers that the definition of ‘all clinical trial data’ is not limited to conventional randomised controlled trials (RCTs), but is meant to include other types of interventional or observational clinical research methodologies, such as large simple trials, cohort studies, case control studies, or registry data. This definition is consistent with that used by the \u0013 HYPERLINK \"https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/clinical-data-publication/background-clinical-data-publication-policy\" \\l \":~:text=The%20European%20Medicines%20Agency%20developed,and%20mechanisms%20to%20ensure%20transparency.\" \u0014European Medicines Agency in its policy on publication of clinical data on medicinal products for human use\u0015.\nNICE requires companies to consent to European Economic Area re","cbCaisPCun4GLz7C","https://ap.wps.com/l/cbCaisPCun4GLz7C","docx",114685,71,"English","# Instructions for companies\n## Evidence submission requirements and format\n## Confidentiality and economic model inclusion\n## Decision problem and technology description\n## Health condition and clinical care pathway","[{\"question\":\"What format and length limits apply to the evidence submission to NICE?\",\"answer\":\"Submissions must be sent electronically in Word or a compatible format, not as a PDF. The main body must not exceed 150 pages, excluding appendices and pages covered by the template.\"},{\"question\":\"Which information must be included regarding confidential content and the economic model?\",\"answer\":\"Confidential information must be highlighted and underlined in the electronic version. An executable electronic copy of the economic model must be included with full access to the programming code, and its content must match the evidence submission.\"},{\"question\":\"What disclosure and regulatory consent obligations do companies have?\",\"answer\":\"The medical director must sign a statement that all required clinical trial data have been disclosed. Companies must consent to European Economic Area regulatory authorities directly providing NICE with all necessary clinical trial data so NICE can use it for the technology evaluation.\"}]","Single technology appraisal and highly specialised technologies evaluation - User guide for company evidence submission template | DOCX",1788212063,25]