Prospective Registration (Before First Participant)
Trials must be registered before enrolment of the first participant in a WHO-recognized public registry such as ClinicalTrials.gov, the WHO ICTRP Primary Registries (e.g., EU CTR/Clinical Trials Register, ISRCTN, ANZCTR, IRCT, UMIN-CTR, ChiCTR, CTRI). The registry name and identifier must appear in the manuscript (preferably in the Abstract and Methods).
- Provide protocol and (when applicable) statistical analysis plan (SAP) as supplementary files or links.
- Report any protocol amendments and update the registry accordingly (e.g., primary outcomes, sample size).
- Retrospective registration is strongly discouraged; if unavoidable, justify in the cover letter and Methods and label the trial as retrospectively registered.