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 |