Skip to main content

Table 1 The 17 data collection categories

From: Using systematic data categorisation to quantify the types of data collected in clinical trials: the DataCat project

CategoryExample
Outcomes
 1. Primary OutcomeAs identified in the trial protocol
 2. Primary outcome but not primary analysisPrimary outcome is weight loss at 12 months but weight loss is also measured at 3 months
 3. Secondary OutcomesAs designated in the trial protocol
 4. Outcome data not listed as primary, secondary or health economics outcome 
 5. Items from a core outcome set 
 6. Health Economics 
Non-outcomes
 7. Participant identification itemsParticipant ID, postal contact details, general practitioner name and contact details
 8. Items needed for randomisationAge, sex, site
 9. Eligibility 
 10. DemographicsAge, sex, family history of condition of interest
 11. Medical History 
 12. Data Management ItemVisit number
 13. Safety DataConcomittant medications
 14. Regulatory DataDeviation logging, reason for withdrawal
 15. Compliance DataDose administered, tablets taken or returned, confirmation of completed processes, randomisation allocation
 16. Process OutcomesHow much blood was collected, who delivered the educational information
 17. Miscellaneous