What needs registration?
1) Clinical trials
Randomized controlled trials
Non-randomized interventional studies
Device trials and procedural trials
Drug and biologic studies
Behavioral and digital health interventions
Pragmatic and cluster trials
2) Observational studies
Prospective cohort studies
Case-control studies
Cross-sectional studies with predefined outcomes
Registry-based observational research
Natural history studies
3) Systematic reviews and meta-analyses
Systematic reviews with predefined protocol
Meta-analyses
Network meta-analyses
Umbrella reviews
Scoping reviews with structured methodology
Registration should occur before data extraction begins.
4) Case reports and case series
Single case reports with structured objective
Case series with predefined inclusion criteria
Rare disease or rare complication reports
Registration is encouraged to document intent, predefined outcomes, and ethical oversight.
5) Diagnostic and prognostic studies
Diagnostic accuracy studies
Validation of prediction models
Biomarker validation studies
Artificial intelligence and algorithm validation
6) Quality improvement and service evaluations
Prospective quality improvement projects
Implementation science studies
Structured service evaluations with predefined endpoints
7) Secondary data and database studies
Predefined analyses of existing datasets
Registry-based secondary analyses
Administrative database studies with predefined outcomes
What does not typically require registration
Narrative reviews without predefined methodology
Editorials and opinion pieces
Letters to the editor
Educational material without research objectives