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The Study Design Categorizer

Q1: Does the study use or collect measurements or assessments about individual humans? YES

Q2: What is the primary mode of inquiry? QUANTITATIVE

Q3: Does the investigator assign one or more interventions? YES

We have now decided that your study is an INTERVENTIONAL study

Question 4: Are there one or more control groups?

Additional descriptors for interventional studies (some may not apply in specific cases: e.g., randomization descriptors don't apply to single group studies):
  • Statistical intent: one of superiority, non-inferiority, equivalence
  • Sequence generation: one of random, non-random
  • Allocation concealment method: * centralised (e.g. allocation by a central office unaware of subject characteristics) or pharmacy-controlled randomisation * pre-numbered or coded identical containers which are administered serially to participants * on-site computer system combined with allocations kept in a locked unreadable computer file that can be accessed only after the characteristics of an enrolled participant have been entered * sequentially numbered, sealed, opaque envelopes* other
  • Assignment to study intervention: factorial, non-factorial
  • Unit of randomization: individual participant, cluster
  • Blinding/Masking: Yes or No of each of: participant, investigator, care provider, outcomes assessor, statistician
  • Control group type: one of active, placebo, sham, usual care, dose comparison, other
  • Study phase: one of Phase 0, 0/1, 1, 1/2, 2, 2/3, 3, 4

Topic revision: r7 - 22 Jul 2009 - 14:20:18 - SimonaCarini

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