[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-168949-en":3,"doc-seo-168949-105":30,"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":4,"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":29},168949,1099523885074,"Riley West","https://ap-avatar.wpscdn.com/davatar_9964176cb1d06d4a9deccf72a44ae3dc",1,17,"Forms","Case Report Consent Form Template - 20250807","Retrospective case report informed consent form template providing regulatory-aligned headings, sample language, and clear instructions for study teams. Guides investigators on formatting, plain lay wording at an eighth-grade reading level, second-person phrasing, and appropriate use of defined terms and TCPS 2 compliance. Specifies what to include (study purpose, procedures, benefits/risks, confidentiality, and review details) and what to avoid (full eligibility criteria, study IDs, page initials, logos, and misleading approval statements).","CONSENT FORM TO PARTICIPATE IN A RESEARCH STUDY\nTEMPLATE\nRETROSPECTIVE CASE REPORT\nGENERAL INSTRUCTIONS\nThe consent form template was designed to meet current regulatory and ethical standards. These documents provide headings and sample text to assist you. The REB recommends that study teams use the template whenever possible and customize it to be accessible and appropriate for your participant groups.\nPlease consult the accompanying guidance document for additional information.\nHow to Use this Template\nHeadings in bold black font and subheadings in italicized black font denote sections which should be used and should not be altered or removed.\nText in black font should be included.\nInstructions are indicated in green font. Sections where investigators need to provide content are denoted by [Insert…].\nSample text/examples are provided in blue/teal font and may be adapted to the study or omitted if they are not relevant to the specific study.\nThe instructions (green font) and options not applicable to your study in blue/teal font should be deleted from the consent form prior to submission to the REB.\nPointers to sections in the main application form or consent form guidance document where relevant information should be found are provided in orange italicized font.\nSample language for your particular study may not be provided in the guidance document or template. If there is no template language for your specific situation, please create your own.\nInformed Consent Form DOs\nUse plain (lay) language throughout that is easy to understand and is accessible to the study population.\nInformation should be provided at an eighth grade reading level. Use the \u0013 HYPERLINK \"https://support.microsoft.com/en-us/office/get-your-document-s-readability-and-level-statistics-85b4969e-e80a-4777-8dd3-f7fc3c8b3fd2\" \u0014Flesch-Kincaid Grade Level score\u0015 to ensure readability.\nWrite in the second person (“You/Your”).\nWhenever possible, avoid using technical/medical terms, acronyms and abbreviations. However, when required, they should be clearly defined at first use.\nConsult the \u0013 HYPERLINK \"https://ethics.gc.ca/eng/policy-politique_tcps2-eptc2_2022.html\" \u0014TCPS 2\u0015 to ensure compliance with regulations/guidelines.\nConsult the Guidance Document for descriptions of information to be included in the Consent Form.\nUse a size and font of text that is consistent and easy to read (size 11 or larger of Arial or Times New Roman is recommended).\nUse the headings provided in the template document.\nEnsure that the final form is properly formatted and free of spelling or grammatical errors. Use spell-check.\nAfter all edits have been made, all text should be black.\nDelete these instructions prior to submission.\nInformed Consent Form DON’Ts\nDo not provide the full inclusion and exclusion criteria.\nDo not include the participant’s unique study identifier on the consent form.\nDo not request the participant to initial every page.\nDo not include any logos.\nDo not state that the CMCC Research Ethics Board has “approved” the study since this may appear to offer a guarantee of safety.\nDo not provide duplicate information.\nDo not leave blank spots to be filled in later (i.e., investigator name).\nDo not change the paragraph spacing in the form.\nREMINDER\nThe signing of the informed consent form is only a component of the informed consent process. In most cases, researchers should have a consent discussion with potential participants, and respond to any questions they may raise before a consent form is signed. Consent is an ongoing process throughout the conduct of the study to ensure consent for participation is maintained.\nFor queries related to the consent form guidance document and/or template, please contact the Office of Research Administration (\u0013 HYPERLINK \"mailto:ora@cmcc.ca\" \u0014ora@cmcc.ca\u0015).\n\u000f\nInformed Consent Form for Retrospective Case Report\nTitle of Case Report\n[Insert study title as it appears on the REB application form]\nInvestigators\nPrincipal Investigator\n[Insert fu","cbCaidOSzlksFIJl","https://ap.wps.com/l/cbCaidOSzlksFIJl","docx",147982,6,"English","en",105,"# How to Use this Template\n## General Instructions\n## Informed Consent Form DOs\n## Informed Consent Form DON’Ts\n## Informed Consent Form for Retrospective Case Report\n## Title of Case Report\n## Investigators\n## Introduction\n## Purpose\n## Procedures\n## Potential Benefits and Risks\n## Confidentiality","[{\"question\":\"Who should use this consent form template and how should it be customized?\",\"answer\":\"The REB recommends study teams use the template when possible and customize it so it is accessible and appropriate for their participant groups. 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Instructions and non-applicable options must be deleted before submission.","Answer",{"name":78,"@type":73,"acceptedAnswer":79},"What writing and readability requirements does the template recommend?",{"text":80,"@type":76},"Use plain (lay) language at an eighth-grade reading level, employ second-person (“You/Your”), and avoid technical/medical terms, acronyms, and abbreviations unless clearly defined at first use. Recommended font size is 11 or larger in Arial or Times New Roman.",{"name":82,"@type":73,"acceptedAnswer":83},"What key items does the template instruct researchers not to include?",{"text":84,"@type":76},"Do not provide full inclusion/exclusion criteria, the participant’s unique study identifier, page-initial requests, logos, or statements implying the study is “approved” in a way that suggests a safety guarantee. 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