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- Published
- Updated
- Sources checked
Results entry should be a controlled transformation of the analysed dataset, not manual copying from whichever report is newest.
CTIS results — Define the regulatory scope
CTR Article 37 and Annex IV describe results disclosure content. The CTIS handbook provides the operational submission steps and fields.
CTIS results — Build the working record
Create a reconciliation sheet for participant flow, analysis populations, endpoints, adverse events and denominators. Identify the approved analysis source, rounding rule and owner for each field; record differences from earlier public information.
CTIS results — Check before release
- Reconcile participant totals across result sections.
- Check units, time points and denominators.
- Review adverse-event counts against the approved analysis.
CTIS results — Record the decision and handover
Have statistics, medical writing and safety owners resolve discrepancies before release. Retain the submitted result dataset, final summaries and receipt so later corrections can be reproduced and explained.
Frequently asked questions
- Does a published paper replace CTIS results?
- No. Assess and fulfil the applicable register submission separately.
- Can all percentages share one denominator?
- No. Use the denominator appropriate to the population and outcome.