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Table 1 Study details required by WHO and Ottawa Group

From: Opinions on registering trial details: a survey of academic researchers

WHO Trial Registration Data Set Ottawa Group Data Set (in addition to WHO items)
Trial registration date Trial acronym
Ethics approval Trial website
Funding source(s) Lay description
Primary sponsor Registration date
Secondary sponsor(s) Date ethical approval
Coordinating/principle investigator Date recruitment end
Contact person Date end of follow-up
Coordinating center Date trial stop
Recruitment center locations Trial extensions
Official scientific title Date primary analyses
Lay title Name of Research ethics board/institutional
Date recruitment start Review board (REB/IRB)
Recruitment status REB trial approval number
Inclusion criteria Rationale of the trial
Exclusion criteria References to systematic reviews
Disease/condition Justification of interventions
Interventions Trial objectives
Primary endpoint Study design
Secondary endpoints Number of arms
Trial phase/study type Generation of allocation sequence
Target sample size Randomization
  Allocation concealment
  Blinding status
  Other design features
  Framework of the study
  Sample size calculation
  Planned subgroup analyses
  Planned analyses methods
  Consent forms
  Full protocol
  Contracts and financial arrangements