Study overview

Question → objectives → population → comparison → endpoints → study approach

Flow diagram

Study overviewStudy overviewF1.S1Research questionF1.S2Study objectivesF1.S3Target population and settingF1.S4Intervention, exposure andcomparisonF1.S5Endpoints and assessmentprimary · unspecifiedF1.S6Study approach and feasibilityF1.S7Protocol and review milestonesF1.N1Study specificationComponentDefinitionRationaleSourcePopulationComparisonStudy contextFeasibilityF1.N2Study rationale and evidenceF1.N3Open design decisions

Steps

Research question

Define the evidence gap, setting and decision the study should inform.

Study objectives

Distinguish primary, secondary, exploratory and safety objectives.

Target population and setting

Specify the intended population and sites or data setting.

Intervention, exposure and comparison

Specify strategies and comparator; state when there is no comparator.

Endpoints and assessment

Define each outcome, measurement method and assessment window.

Study approach and feasibility

Choose an interventional or observational approach and assess feasibility.

Protocol and review milestones

Record protocol version, responsible reviewers and required approvals.

Tables and supporting information

Study specification

Study specificationComponentDefinitionRationaleSourcePopulationComparisonStudy contextFeasibility

Use separate rows for unresolved design decisions.

Study rationale and evidence

Cite evidence for the research gap and intended comparison.

Open design decisions

Identify limitations, owners and decisions that must be resolved before study initiation.

Sources