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It specifies that headings should be selected according to relevance and that alternative protocol templates may apply to clinical trial proposals. Guidance covers where to map existing documents to template fields, avoids duplicating information between systems, and encourages language understandable to non-technical ethics reviewers. Recommended sections span roles, resources, background, design, participants, activities, data handling, analysis, outcomes, investigational product details, and closure.","Project Description/Protocol\nNote that:\nthe purpose of a Project Description is to provide the scientific and academic background and context of a research project;\na Project Description is a mandatory component of a submission using the HREA;\nthe section headings in this Project Description template represent a structure for presentation of information about a research project that meets the needs of an ethics review body;\nnot all headings or sub-headings in this template are relevant for each research project;\nsubmissions of clinical trial proposals may use alternative protocol templates, such as the \u0013 HYPERLINK \"http://www.spirit-statement.org/\" \\t \"_blank\" \u0014SPIRIT statement\u0015;\nresearchers may choose to submit an existing document (such as a protocol or project description that has already been developed) instead of developing a new document;\nif researchers choose to submit an existing document instead of using one of the templates provided, they may need to provide indications to the ethics review body of where in the submitted document the content corresponding to the relevant fields in the template are located;\nthere is no need to duplicate information in the HREA into the Project Description or vice versa; and\nlanguage that is understandable to non-technical reviewers should be used.\nResearchers are strongly encouraged to address the following headings in their Project Description. Each dot point provides an example of the information that researchers might want to include, if relevant to their project.\nTitle\nAcronym (if appropriate)\nVersion number\nProject Team Roles & Responsibilities\nNames, affiliations, positions and responsibilities of investigators and other key project team members (as required in addition to that outlined in the HREA)\nResources\nResources necessary for the project to be conducted\nFunding/support being sought or secured\nBackground\nLiterature review\nRationale/Justification (i.e. how the research will fill any gaps, contribute to the field of research or contribute to existing or improved practice)\nResearch questions/aims/objectives/hypothesis\nExpected outcomes\nProject Design\nResearch project setting (physical sites, online forums and alternatives)\nMethodological approach\nRationale for choices of method/s (tied to project aims/objectives)\nParticipants\nDescription and number\nInclusion and exclusion criteria\nSample size and statistical or power issues\nParticipant recruitment strategies and timeframes (as required in addition to that outlined in the HREA)\nApproach/es to provision of information to participants and/or consent (as required in addition to that outlined in the HREA)\nIf necessary, the type of consent provided to different participant groups, when and where, and any arrangements to confirm that consent.\nIf necessary, details of who will be confirming or re-negotiating consent with participants and the process/es that will be undertaken\nResearch Activities: What you are going to do?\nParticipant commitment\nProject duration\nParticipant follow-up\nData Collection/Gathering: What information are you going to collect/gather? (as required in addition to that outlined in the HREA)\nData collection/gathering techniques: How will you collect/gather the information?\nImpact of and response to participant withdrawal\nData Management: How will you store, provide access to, disclose, use/re-use, transfer, destroy or archive the information that you collect/gather? (as required in addition to that outlined in the HREA)\nData Analysis: How will you measure, manipulate and/or analyse the information that you collect/gather?\nMatching and sampling strategies\nAccounting for potential bias, confounding factors and missing information\nStatistical power calculation\nData Linkage: What linkages are planned or anticipated?\nOutcome measures\nFor research involving an investigational drug or device as part of a clinical trial: What is/are the drug(s) and/or device(s):\nApproved name\nTrade name (if any)\nManufacturer\nSupplier of ","cbCainWYij9JeufF","https://ap.wps.com/l/cbCainWYij9JeufF","docx",16976,2,3,"English","en",105,"# Purpose and submission guidance\n## Key requirements for HREA\n## Relevance of template headings\n# Recommended content sections\n## Title and project team roles\n## Resources and background\n## Research questions and expected outcomes\n## Project design and participant details\n## Research activities and participant follow-up\n## Data collection, management, analysis, and linkage\n## Outcome measures and investigational drug/device details\n## Results, dissemination, closure, and data sharing","[{\"question\":\"What is the purpose of a Project Description in this template?\",\"answer\":\"It provides scientific and academic background and research context for an ethics review submission. 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It is a mandatory component for submissions using HREA.","Answer",{"name":77,"@type":72,"acceptedAnswer":78},"Which headings from the template should be included?",{"text":79,"@type":75},"Researchers are strongly encouraged to address the provided headings, but not all sections are relevant to every research project. Choose the headings that meet the ethics review body’s needs.",{"name":81,"@type":72,"acceptedAnswer":82},"Can researchers submit an existing protocol or project description instead of using the template?",{"text":83,"@type":75},"Yes. 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