[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-seo-160765-105":3,"detail-sidebar-cat-1-en-105":80,"doc-detail-160765-en":126},{"code":4,"msg":5,"data":6},0,"ok",{"site_id":7,"language":8,"slug":9,"title":10,"keywords":11,"description":12,"schema_data":13,"social_meta":73,"head_meta":75,"extra_data":77,"updated_unix":79},105,"en","statistical-analysis-plan-sap-study-overview-template","Statistical Analysis Plan (SAP) - Study Overview - Template","","Statistical Analysis Plan (SAP) template providing a structured framework for biostatisticians to document the study background, aims, hypotheses, study population, data acquisition, and the relationships between outcomes, exposures, and covariates. It guides authors to specify primary and secondary hypotheses and outcomes, define inclusion and exclusion criteria, describe data sources and variable calculations, and map each analysis step back to objectives. 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It also supports consistent reporting of analyses linked to aims and hypotheses.","Answer",{"name":65,"@type":60,"acceptedAnswer":66},"How should study aims, hypotheses, and outcomes be structured in the SAP?",{"text":67,"@type":63},"The template instructs authors to write study aims in scientific terms and hypotheses in statistical terms, including primary and secondary hypotheses. It also recommends specifying only 1–2 primary outcomes, with the remainder as secondary outcomes.",{"name":69,"@type":60,"acceptedAnswer":70},"What information is required for study population and data acquisition?",{"text":71,"@type":63},"The SAP should include inclusion and exclusion criteria, and fill in relevant data acquisition details. 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Instructions are in red and should be deleted when completing the SAP. The purpose of this template is to provide a general layout, but sections can be reformatted as you wish.\nThe creation of this template for the Duke BERD Methods Core was made possible by Grant Number UL1TR002553 from the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research.\nStudy Overview\nBackground/Introduction: This section should be written by the author of the SAP so other biostatisticians can easily follow and to ensure everyone understands the background and goals of the project. If pieces are copied from the protocol or other documents, cite the document. References are not necessary here.\nStudy Aims\n[insert aims (this is in scientific terms)]\nStudy Hypotheses\n[insert hypotheses (this is in statistical terms)]\nIf the analysis is descriptive, simply say so and skip the rest of this section.\nPrimary Hypotheses\n[insert]\nYou should only have 1-2 primary hypotheses and the rest should be secondary.\nSecondary Hypotheses\n[insert]\nStudy Population\nInclusion Criteria\n[insert]\nExclusion Criteria\n[insert]\nData Acquisition\nFill in all relevant information:\nNotes: Include any additional details that give information about how this data set was acquired.\nDescription:\n[insert]\nOutcomes, Exposures, and Additional Variables of Interest\nIf you choose not to use the table format below, make sure all the information outlined below is still included.\nPrimary Outcome(s)\nYou should only have 1-2 primary outcomes and the rest should be secondary.\nSecondary Outcome(s)\nAdditional Variables of Interest\nThis is optional but generally this would be all your covariates of interest. If there are any variables that need special calculations etc. include them here or in a data dictionary that is an appendix to this SAP which you can reference here.\nStatistical Analysis Plan\n[insert]\nEvery analysis step should refer back to an aim/hypothesis/objective. You can include just one deadline for the project, but if there are multiple major stopping points, you should include individual deadlines for each milestone. Good practice is to number each item here and reference them in your code. If you have to wait for data, you should include a disclaimer that X analysis cannot be completed until the data is collected and deadlines cannot be determined until you receive the data.\nFor more details on what to include, see the SAP Checklist document.\nDemographic and Clinical Characteristics (“Table 1”)\n[insert]\nAnalyses Plan for Aim 1\n[insert]\nAnalyses Plan for Aim 2\n[insert]\nETC\nLimitations\nAll design and analysis limitations (this will grow as you do the study and should be included in the report)\nAddendum for Additional Analyses\n[insert if applicable]\nAll post-hoc analyses should be described here. If minor changes are made to the main analysis (e.g. adding a covariate to the model), this can be changed in the main analysis section above and a note should be added to the activity log.\nAppendix\nThis section can be used to include table shells, example figures, or anything else that does not belong in the body of the SAP but you feel should be included.\nReferences\nIf needed, this section can included citations to statistical methods, programming software (including R packages), and/or relevant clinical literature.\n\u000f\nStatistical Analysis Plan Checklist\nBelow you will find a checklist of recommended items to include in a statistical analysis plan. Some of these are specific to clinical trials (based on this \u0013 HYPERLINK \"https://jamanetwork.com/journals/jama/fullarticle/2666509\" \u0014JAMA paper\u0015) and some are other are specific to observational studies (based on \u0013 HYPERLINK \"https://www.strobe-statement.org/index.php?id=available-checklists\" \u0014STROBE\u0015/\u0013 HYPERLINK \"http://www.record-statement.org/\" \u0014RECORD\u0015 guidelines), so every item will not be ne","cbCaimpsL5s4RPIO","https://ap.wps.com/l/cbCaimpsL5s4RPIO","docx",86454,10,"English","# Study Overview\n## Background/Introduction\n## Study Aims\n## Study Hypotheses\n## Study Population\n## Data Acquisition\n## Outcomes, Exposures, and Additional Variables of Interest\n## Statistical Analysis Plan\n## Demographic and Clinical Characteristics (“Table 1”)\n## Analyses Plan for Aim 1\n## Analyses Plan for Aim 2\n## Limitations\n## Addendum for Additional Analyses\n## Appendix\n## References","[{\"question\":\"What is the purpose of this Statistical Analysis Plan (SAP) template?\",\"answer\":\"It provides a general layout to document the SAP so other biostatisticians can follow the study context, objectives, and analysis logic. It also supports consistent reporting of analyses linked to aims and hypotheses.\"},{\"question\":\"How should study aims, hypotheses, and outcomes be structured in the SAP?\",\"answer\":\"The template instructs authors to write study aims in scientific terms and hypotheses in statistical terms, including primary and secondary hypotheses. It also recommends specifying only 1–2 primary outcomes, with the remainder as secondary outcomes.\"},{\"question\":\"What information is required for study population and data acquisition?\",\"answer\":\"The SAP should include inclusion and exclusion criteria, and fill in relevant data acquisition details. It also asks for descriptions of the dataset acquisition process and any additional notes that explain how the data were obtained.\"}]","Statistical Analysis Plan (SAP) - Study Overview - Template | DOCX"]