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nejm-study-design

Use to confirm study-design rigor and the mandatory prospective trial registration, protocol, and statistical analysis plan before writing up a clinical study for NEJM. Surfaces registration problems early — they cannot be fixed retroactively.

NEJM-Skills/skills/nejm-study-design/SKILL.md

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# Study Design & Registration (nejm-study-design)

## When to trigger

- A trial is being written up and you must confirm it was registered **before enrollment**.
- There is no finalized protocol or statistical analysis plan to submit.
- The design (randomization, blinding, endpoints) needs to be stated rigorously for the Methods.
- An observational study needs its design (cohort / case-control / cross-sectional) named and justified.

## The non-negotiable: prospective trial registration

Per **ICMJE** policy (which NEJM enforces), a clinical trial must be **prospectively registered** in a public registry — **ClinicalTrials.gov** or a **WHO ICTRP** primary registry — **before the first patient is enrolled**. This is a deal-breaker, not a formatting detail.

- The **trial registration number** (e.g., an NCT number) is reported in the abstract and Methods.