[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-164888-en":3,"doc-seo-164888-105":30,"detail-sidebar-cat-1-en-105":92},{"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},164888,2336475104736,"วิน","https://ap-avatar.wpscdn.com/avatar/22000c4c5e0e5b17e70?x-image-process=image/resize,m_fixed,w_180,h_180&k=1786591360781797222",1,17,"Forms","ULACNet Protocol Template - Instructions","ULACNet protocol template instructions for rapid development of clinical trial protocols for submission to the National Cancer Institute (NCI) Division of Cancer Prevention. It specifies required components for an administratively complete initial submission, including the ULACNet Protocol Submission Worksheet, the protocol language and template version control, aligned informed consent/assent materials, IRB/ethics approvals for accrual readiness, and recruitment materials. It also defines elements for subsequent revisions and amendments, submission logistics, formatting rules, and change-tracking terminology.","National Institutes of Health\nNational Cancer Institute\nDivision of Cancer Prevention\nUS-Latin American-Caribbean HIV/HPV Cancer Prevention Clinical Trials Network (ULACNet)\nPROTOCOL TEMPLATE\nINSTRUCTIONS\nThe protocol template is a tool to facilitate rapid protocol development. It is not intended to supersede the role of the Protocol Principal Investigator in the authoring and scientific development of the protocol. It contains the language required in protocols submitted to the National Cancer Institute (NCI) Division of Cancer Prevention (DCP). Please modify all sections as necessary to meet the scientific aims of the study and development of the protocol. For ULACNet, a Partnership Center is a collaboration between a research institution in the United States as the Lead Academic Organization (LAO) and Affiliate Organizations (AOs) in the US and low- and middle-income countries (LMICs) in the Latin American and Caribbean (LAC) region.\nAn “administratively complete” initial protocol submission must include the following components:\nULACNet Protocol Submission Worksheet (PSW): This document contains prompts for required administrative information. The PSW is required for all protocol submissions including the original protocol, revisions, and amendments. It must match the version and date of the other documents submitted.\nProtocol: The template document attached to these instructions provides standard language plus instructions and prompts for information required in each ULACNet protocol. Please ensure the current version of the template always is used for protocol development.\nInformed Consent/Assent Form(s): Please use the informed consent (IC) or informed assent (IA) templates provided as a guideline and include any other sections required by your institution. Only the English version of IC/IA is required. Note: The IC (and IA if applicable) and Protocol must have the same date and version number.\nIRB/Ethics Board Approval: This may be pending during first protocol submission, but the award prohibits expending human subject funds before IRB approval. IRB approval must be received from the US-based institution and one international site for the trial to be “open to accrual”. All other international site IRB/ethics board approvals must be submitted as received.\nRecruitment Materials: Collection is for recruitment repository only. They will not be translated. NCI review will not occur.\nAny other study related documents as applicable.\nAll subsequent submissions (protocol revisions and amendments) must include:\nProtocol Submission Worksheet (PSW)\nCover Letter: The cover letter must include a point-by-point response to each item listed in the concurrence review or requested amendments.\nTracked Changes Version of Protocol/IC/IA if applicable\nClean Copy Version of Protocol/IC/IA if applicable\nUpdated Additional Study-Related Documents: Include changes resulting from a protocol revision or amendment.\n“Administratively Incomplete” submissions will be returned to the Partnership Center for completion. The review process will begin following receipt of an administratively complete submission.\nFormatting\nAll Protocol Template instructions and prompts are in italics. Italicized information should be deleted prior to submitting the protocol to DCP.\nPlease note that the Protocol Template has built-in styles for headings levels 1–4 (Level 1 Heading – Level 4 Heading). These heading styles will automatically update the Table of Contents (TOC) and convert to Bookmarks in a final PDF protocol document. Please retain the heading styles and do not edit the TOC manually.\nIndicate changes using the ‘tracked changes’ function, highlighting, or underlining new or modified text in protocol revisions or amendments to facilitate the review process.\nWherever possible, please use the date format: day month year and write out the month (e.g., 05 June 2020).\nPlease update the header of this template document before submission with the protocol number and ","cbCaioUJcWquF0CW","https://ap.wps.com/l/cbCaioUJcWquF0CW","docx",116054,27,"English","en",105,"# ULACNet protocol template instructions\n## Initial administratively complete submission components\n## Subsequent submissions (revisions and amendments)\n## Formatting and document handling rules\n## Submission process and contacts\n## Cover page fields","[{\"question\":\"What are the mandatory components for an administratively complete initial ULACNet protocol submission?\",\"answer\":\"It must include the ULACNet Protocol Submission Worksheet (PSW), the protocol using the current template language/version, informed consent/assent documents with matching date and version, IRB/ethics approvals sufficient to open the trial to accrual, recruitment materials for repository use, plus any other applicable study documents.\"},{\"question\":\"What must be included in subsequent submissions for protocol revisions and amendments?\",\"answer\":\"Each subsequent submission must include the PSW, a cover letter with point-by-point responses to concurrence or requested changes, tracked-changes and clean-copy versions of the protocol and IC/IA as applicable, and updated additional study-related documents reflecting the revision or amendment.\"},{\"question\":\"What formatting and change-tracking requirements apply to protocol documents?\",\"answer\":\"Use built-in heading styles (Level 1–4) and do not manually edit the TOC. 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