[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-307036-105":53,"doc-detail-307036-en":126},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":119,"head_meta":121,"extra_data":123,"updated_unix":125},105,"en","mdic-efs-icf-template-v1-13-apr-2022","MDIC EFS ICF Template - V1 - 13 Apr 2022","","This document provides an Informed Consent Form template for participation in an Early Feasibility Study under the MDIC EFS program. It acknowledges the Informed Consent and IRB working group, cites FDA guidance on Investigational Device Exemptions for early feasibility medical device clinical studies, and explains sponsor responsibilities, study purpose, eligibility review by a physician, and the ethical oversight role of the IRB. Placeholders define study title, device and sponsor information, investigator contacts, study procedures after consent, and the study’s risks, limited data, and potential benefits.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":36,"@type":70,"position":76},"https://docshare.wps.com/template/forms/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/mdic-efs-icf-template-v1-13-apr-2022/307036/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/mdic-efs-icf-template-v1-13-apr-2022/307036.png","ImageObject",442,249,{"name":88,"@type":89},"Eliana","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-22","2026-09-19",true,{"@type":98,"interactionType":99,"userInteractionCount":30},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What is the purpose of an Early Feasibility Study in this template?","Question",{"text":108,"@type":109},"The template explains that the study aims to evaluate the device to help treat the specified medical condition, focusing on initial safety and performance when used for that purpose.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"What approvals are required before the study can be conducted?",{"text":113,"@type":109},"Each research site must get approval from an Institutional Review Board (IRB), which reviews the protocol and informed consent to protect ethics and participant rights and welfare.",{"name":115,"@type":106,"acceptedAnswer":116},"Can any medical tests or procedures be performed before signing the consent form?",{"text":117,"@type":109},"No study-related tests or procedures will be done before you sign this consent form.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},307036,1790216509,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":35,"category_name":36,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":30,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":8,"language":135,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":61,"update_tm":139,"read_time":79},4398048949847,"https://ap-avatar.wpscdn.com/avatar/400002536579ef2da7f?_k=1778318612642679267","MDIC would like to acknowledge the efforts of the Informed Consent and Institutional Review Board working group within the Early Feasibility Studies (EFS) program. This working groups expertise and substantial contribution to this agreement is critical to the mission and goals of the EFS program and we thank the following individuals for their work:  \nKatie Wozniak, Advocate Aurora  \nSuzanne LaScalza, Cerenovus/Johnson & Johnson Nora Hadding, JD, Imperative Care  \nMohamad Bydon, MD, Mayo Devjani Saha, PhD, MCRA Nathan Lampi, JD, Medtronic Sheila Warner, MicroVention Michaella Corso, Penumbra, Inc.  \nHolly Keller, BSN, RN, Stryker Elizabeth Boyd, PhD UC Steve Hetts, MD, UCSF  \nMaxim Mokin, MD, University of South Florida  \nThe efforts in developing this agreement will prove to be instrumental in advancing early feasibility work and may provide US patients’ earlier access to potentially helpful medical technologies.  \nPhone 202-828-1600 [website](website www.mdic.org)[ www.mdic.org](website www.mdic.org) Address 1501 Wilson Blvd. Suite 910, Arlington, VA 22209  \nMDIC EFS ICF Template 13 Apr 2022  \nIMPORTANT NOTE: This Informed Consent Form Template is based on FDA Guidance\"Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical studies, Including Certain First in Human (FIH) Studies\", Appendix 3* . It is provided as a courtesy to Study Sponsors. Certain paragraphs and sections in this template may not apply based on investigational device and study requirements. The informed consent form should be adapted to reflect the device/procedure and prior experience with the device for the medical condition treated so the patient can make a well-informed decision. The informed consent form should reflect the study needs, regulatory and institutional review board  \nrequirements  \n*[https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigational](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigational)device-exemptions-ides-early-feasibility-medical-device-clinical-studies-  \nts/ucm279103.pdf  \nINFORMED CONSENT TO PARTICIPATE IN AN EARLY FEASIBILITY STUDY Title of Study: EARLY FEASIBILITY STUDY OF THE [INSERT DEVICE NAME]  \nPrincipal Investigator: [INSERT INVESTIGATOR NAME]  \nSponsor: [INSERT SPONSOR NAME]  \nEmergency Telephone: [INSERT INVESTIGATOR PHONE]  \nINTRODUCTION  \nYou have been invited to join an Early Feasibility Study to evaluate the [INSERT GOAL OF STUDY] of [INSERT NAME OF THE DEVICE] . The device is investigational and not approved by the FDA for your medical condition. A description of this study will be available at [http://www.clinicaltrials.gov](http://www.clinicaltrials.gov) (reference study number), as required by law.  \n• This study is sponsored by [INSERT SPONSOR NAME] . Before you decide if you want tobe involved in the study, it is important that you read and understand this information. Be sure to ask questions about anything that is unclear. Your Physician will answer your questions about the study, the device or any of the information being presented.  \n• The FDA or regulatory body has approved the clinical use of this device in an early feasibility study.  \nNo study-related tests or procedures will be done before you sign this consent form.  \nPURPOSE AND BACKGROUND  \nThe reason we are doing this research study is to look at the [INSERT STUDY DEVICE] to see if it can help treat [INSERT MEDICAL CONDITION] . This type of research study is called a “early feasibility study”. Early feasibility studies typically evaluate innovative devices or innovative uses of approved devices. These studies enroll a small number of patients and provide initial information on the basic safety and performance of the study device when used to treat [INSERT  \nBRIEF DESCRIPTION OF MEDICAL CONDITION] . There is often only limited data and experience treating this condition with the study device. Since, this is an early feasibility study, some risks ar","cbCaipMtXVe7df9s","https://ap.wps.com/l/cbCaipMtXVe7df9s","pdf",292090,"English","# Introduction\n## Purpose and Background\n## Prior Information Available on the Device\n## Who Can Participate in the Study","[{\"question\":\"What is the purpose of an Early Feasibility Study in this template?\",\"answer\":\"The template explains that the study aims to evaluate the device to help treat the specified medical condition, focusing on initial safety and performance when used for that purpose.\"},{\"question\":\"What approvals are required before the study can be conducted?\",\"answer\":\"Each research site must get approval from an Institutional Review Board (IRB), which reviews the protocol and informed consent to protect ethics and participant rights and welfare.\"},{\"question\":\"Can any medical tests or procedures be performed before signing the consent form?\",\"answer\":\"No study-related tests or procedures will be done before you sign this consent form.\"}]","MDIC EFS ICF Template - V1 - 13 Apr 2022 | PDF",1789843440]