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Structure patterns by document family
Chapter 3 of 292 min read
Structure is not a universal list of headings. It is the ordered logic of the document. The patterns below are starting maps derived from the corpus; live targets may require different labels and order.
Research manuscript pattern
Title and authors
Abstract
Keywords / registration / required statements
Introduction: problem → current knowledge → gap → objective
Methods: design → population → intervention/exposure → outcomes → analysis → ethics
Results: flow/population → primary → secondary → other → safety
Discussion: synthesis → comparison → explanation → strengths/limitations → implication
Conclusion
Acknowledgments, contributions, funding, disclosures
References
Tables, figures, supplements
Review pattern
Title and abstract
Why the review is needed
Question and scope
Search and selection method at the rigor actually used
Thematic or evidence-based synthesis
Areas of agreement, disagreement, and uncertainty
Implications and gaps
Conclusion bounded by the evidence set
Disclosures and references
Systematic reviews add reproducible methods, study flow, included-study characteristics, appraisal, and synthesis results as formal research components.
Protocol pattern
Administrative identity and synopsis
Background and rationale
Objectives and estimands/endpoints as applicable
Design
Population and eligibility
Interventions and procedures
Assessments and schedule
Safety monitoring
Data handling and quality
Statistical approach
Ethics, consent, registration, and dissemination
References and appendices
CSR pattern
Title and synopsis
Ethics and administrative information
Investigators and study centers
Introduction and objectives
Investigational plan and analyses
Study population and conduct
Efficacy evaluation
Safety evaluation
Conclusions
Tables, figures, narratives, appendices, and references
Integrated summary pattern
Decision context and development strategy
Evidence inventory
Cross-study methods and comparability
Integrated efficacy / performance / value evidence
Integrated safety / risk evidence
Subgroups and special populations
Uncertainty, limitations, and missing information
Overall conclusions and implications
Supporting tables and source map
Patient-information pattern
What this information is and who it is for
Why the topic or study matters
What will happen / what happened
Benefits, risks, and uncertainty
Choices or actions for the reader
Privacy and support information where relevant
Where to learn more
Glossary or visual explanation as needed