Draft4RCT

High-Level Concepts

• Events
• Periods
  • Study phases
  • Protocol phases
• Sequence of events
• Study designs
• Research types

**Randomized Clinical Trial

• Methods
• Stakeholders
  • Participants
  • Investigators
  • Monitors
  • Sponsors
• Populations

**Screened population

• • Recruited population
  • Eligible population
  • Enrolled population
  • Randomized population
  • Analysed population
  • Crossover population
  • Subgroup population
• Variables
  • Independent variable

***Intervention

• • • • Procedure
      • Device implantation
      • Drug treatment
      • Placebo treatment
      • Sham procedure
      • Usual care
      • Counseling
    • Cointervention
  • Dependent variable (responding variable)
    • Outcome

****Primary outcome

• • • • Secondary outcome
      • Adverse event/Side effect
      • Ancillary outcome
• Digital and paper artifacts
• Protocol

***Intended protocol

• • • Executed protocol
• Protocol application
  • Assessments
    • Experimental assays
    • Observations
      • Physical exam
    • Interview
    • Self-assessments
  • Data analysis
    • Data partitioning
    • Data transformation
    • Data pooling
    • Data summarization
    • Reliability
    • Correlation
  • Specimen processing
    • Procurement
    • Specimen partitioning/purification
    • Specimen storage
• Measurement scale
  • Nominal
  • Ordinal
  • Interval
  • Ratio
• Participant characteristic (phenotype)

**Baseline characteristic