[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-169598-en":3,"doc-seo-169598-105":29,"detail-sidebar-cat-1-en-105":91},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":11,"category_id":12,"category_name":13,"doc_title":14,"doc_description":15,"doc_content":16,"file_id":17,"file_url":18,"file_type":19,"file_size":20,"view_count":11,"is_deleted":4,"is_public":11,"is_downloadable":11,"audit_status":11,"page_count":21,"language":22,"language_code":23,"site_id":24,"html_lang":23,"table_of_contents":25,"faqs":26,"seo_title":27,"seo_description":15,"update_tm":28,"read_time":11},169598,549768702563,"Fahsai","https://ap-avatar.wpscdn.com/avatar/8000c4aa63b76e948b?x-image-process=image/resize,m_fixed,w_180,h_180&k=1786536092046926083",1,17,"Forms","Investigational Device Accountability log - Site","Investigational Device Accountability log – Site template supports documentation of clinical investigations with medical devices in line with EU Regulation 2017/745 (MDR). The form is intended for use at the clinical investigation site(s) to record the physical storage location of all investigational devices from reception through return or disposal. It also specifies that device identification must be adapted to each study, includes versioning guidance, and highlights retaining shipment packing slips for traceability.","Investigational Device Accountability log – Site\n\u0003Clinical Investigations with Medical Devices\u0004\nDetta dokument är framtaget och kvalitetssäkrat av Kliniska Studier Sverige.\nVi utvecklar och erbjuder stöd för kliniska studier i hälso- och sjukvården.\nStödet vi erbjuder ger goda förutsättningar för kliniska studier av hög kvalitet.\nIntroduction to the “Investigational Device Accountability log – Site” template\nThis page is not included as part of the “Investigational Device Accountability log - Site” template, but gives a short introduction to you, who will use this template. This page should be removed when using this form. This “Investigational Device Accountability log - Site” template aims to serve as a help document to facilitate your work. The template may need adjustments so that it fits your clinical investigation.\nThe planning and execution of a clinical investigation with a medical device initiated on or after May 26, 2021 shall comply with the EU Regulation 2017/745 on Medical Devices (MDR). The Investigational Device Accountability log is designed to comply with the MDR.\nThis form should be used at the clinical investigation site(s) to document the physical location of all investigational devices from reception to return or disposal of the investigational device. Identification of the investigational device has to be adjusted according to each study.\nVersion: 18 August 2021\nThe national network for clinical investigations with medical devices within the node organization connected to Clinical Studies Sweden (Kliniska Studier Sverige) is responsible for the template.\nThe template will be reviewed regularly by the national network. Any suggestions for improvement of this template can be sent to any of the email addresses provided below and the designated contact at the respective regional node can then further lift the proposal. Contact information for the regional nodes:\nGothia Forum: \t\u0013 HYPERLINK \"mailto:gothiaforum@vgregion.se\" \u0014gothiaforum@vgregion.se\u0015\nForum Norr: \t\u0013 HYPERLINK \"mailto:forumnorr@regionvasterbotten.se\" \u0014forumnorr@regionvasterbotten.se\u0015\nForum Mellansverige:\t\u0013 HYPERLINK \"mailto:Info-fou@ucr.uu.se\" \u0014Info-fou@ucr.uu.se\u0015\nForum Sydost: \t\u0013 HYPERLINK \"mailto:forumo@regionostergotland.se\" \u0014forumo@regionostergotland.se\u0015\nForum Stockholm-Gotland:\t\u0013 HYPERLINK \"mailto:feasibility.karolinska@sll.se\" \u0014feasibility.karolinska@sll.se\u0015\nForum Söder: \t\u0013 HYPERLINK \"mailto:forumsoder@skane.se\" \u0014forumsoder@skane.se\u0015\nINVESTIGATIONAL DEVICE ACCOUNTABILITY LOG – SITE\nDevice Storage location:…………………………………………….\nNOTE: Retain a copy of the packing slip for all shipments received and sent.\nSignature Principal Investigator:……………………………………………………… Date:……………………………………………………………….","cbCaild20dHSW6Q0","https://ap.wps.com/l/cbCaild20dHSW6Q0","docx",122194,3,"English","en",105,"# Introduction\n## Regulatory basis and purpose\n## How to use the log at the site\n## Template ownership, review, and contact network\n# Log fields\n## Device storage location\n## Shipment packing slip retention\n## Signature and dating","[{\"question\":\"What is the purpose of the Investigational Device Accountability log – Site template?\",\"answer\":\"It documents the physical location of all investigational devices at the clinical investigation site(s) from reception to return or disposal, supporting accountability and traceability.\"},{\"question\":\"Which regulation governs clinical investigations with medical devices referenced by the template?\",\"answer\":\"Planning and execution of such investigations initiated on or after May 26, 2021 must comply with EU Regulation 2017/745 on Medical Devices (MDR).\"},{\"question\":\"What records must be retained for shipments received and sent?\",\"answer\":\"A copy of the packing slip for all shipments received and sent should be retained.\"}]","Investigational Device Accountability log - 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