Description

The World Health Organization and the International Committee of Medical Journal Editors have described the minimal data set for full registration of a clinical trial.


 

Minimal data elements:

(1) unique trial number assigned by the trial registry

(2) trial registration date

(3) secondary ID(s), if indicated

(4) funding source(s)

(5) primary sponsor

(6) secondary sponsor(s)

(7) responsible contact person (for contact by public)

(8) research contact person (for scientific inquiries)

(9) title of the study

(10) official scientific title of the study

(11) research ethics review

(12) medical condition being studied

(13) interventions and study description (controls, durations, etc.)

(14) key inclusion and exclusion criteria

(15) study type (type of masking, type of controls, group assignment, randomized vs nonrandomized)

(16) anticipated trial start date

(17) target sample size

(18) recruitment status

(19) primary outcome

(20) key secondary outcomes

 


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