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The report must describe changes since the end of the last reporting period and assess their impact on trial participants and on the trial, staying limited to events that occurred during the reporting period. 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You can choose an earlier date if more convenient to you.The report is submitted once a year, throughout the duration of the clinical trial.\nThe progress report must focus on the changes that have occurred since the end of the last reporting period, as well as the impact of these changes on the trial participants and the trial.\nDo not write in this report changes or events that have not occurred during the reporting period. Keep the report short and to the point.\nThis template may include chapters and topics not applicable for the clinical trial, for the reporting period. If appropriate, indicate in the concerned chapters «N/A» or «There have been no changes or events since the end of the last reporting period», but do not delete these chapters.\nDo not use this template for writing a progress report for clinical trials with medical devices (MD, IVD-MD), use instead the dedicated template published on swissethics.ch / templates / notifications.\nThe progress report must be submitted to the competent ethics committee, even if no research centres in Switzerland or worldwide have enrolled participants in the trial.\nDo not write in the progress report or annex any personal data of the trial participants. Do not provide information that reveals treatment assignment in a blinded trial: this could invalidate the clinical trial.\nSection headings and template texts formatted in regular type (black) should be maintained as provided in the template. Delete the instructions written in blue before finalizing the progress report.\nIn places where the information is redundant, it is acceptable to reference another chapter, to document or to state its redundancy. But the chapter itself should not be deleted.\nFooter should contain the following information (on all pages): [progress report ID number], [version x, DD/MM/YYYY], [Page x of xx].\nThe progress report is submitted to the competent ethics committee through BASEC. Submit the progress report with the submission form «Safety notification and reporting». Consult the \u0013 HYPERLINK \"https://basec-faq.swissethics.ch/knowledgebase.php?article=26\" \u0014FAQs\u0015 on the correct use of the form.\nFor clinical trials of category B and C the progress report must also be submitted to Swissmedic.\nThe reporting period for the first progress report starts with the approval date of the clinical trial and ends after one full year. The progress report is submitted once a year, throughout the duration of the clinical trial in Switzerland, and the last submitted progress report must cover the Last Trial Participant Last Visit (LPLV) in Switzerland.\nIn case of international clinical trials, after the submission of the progress report covering LPLV in Switzerland, there is no need for further submissions. The information on the global status of the trial after the LPLV in Switzerland will be captured in the final clinical study report.\nInstructions on the reporting of the end of the clinical trial to the ethics committee are available \u0013 HYPERLINK \"https://basec-faq.swissethics.ch/knowledgebase.php?article=28\" \u0014here\u0015.\nVersion 1.4, version date 27.08.2025\nAnnual Safety and General Progress Trial Report\n1. General information\nTitle of the clinical trial: \u0013 FORMTEXT \u0014[free text]\u0015\nGeneral Progress Trial Report number: \u0013 FO","cbCaibToNLwakKEK","https://ap.wps.com/l/cbCaibToNLwakKEK","docx",65237,8,"English","# Annual Safety and General Progress Trial Report\n## 1. General information\n## 2. Executive Summary\n## 3. Trial Progress","[{\"question\":\"What timeframe does the first annual progress report cover?\",\"answer\":\"The first reporting period starts with the approval date of the clinical trial and ends after one full year. The report is submitted once a year during the trial’s duration.\"},{\"question\":\"What should the progress report focus on?\",\"answer\":\"It must focus on changes that occurred since the end of the last reporting period and describe their impact on trial participants and on the trial. Changes not occurring during the reporting period must not be included.\"},{\"question\":\"How should confidentiality and blinded trial information be handled?\",\"answer\":\"Personal data of trial participants must not be included. Information that reveals treatment assignment in a blinded trial must not be provided, as it could invalidate the clinical trial.\"}]","Annual Safety and General Progress Trial Report - ClinO | DOCX",1788284179]