Data items for prospective registration of controlled trials

Unique identification
Source of record*
Serial no. at source*

Trial details
Grant title/title of trial*
Design/methodology*
Topic/objectives/aim
Eligibility criteria*
Groups/interventions*
Endpoints/primary outcomes
Planned sample size

Status
Start date (recruitment)
End date (recruitment)
Follow up duration for primary endpoints

Contact (responsible for record)
Contact name(s)*
Contact details*

* Essential information which is required for each controlled trial.