Agent skill · Documentation

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.

brycew6m878★ · +32/wk · 1 repos on radarProfile →
claude-codeMIT
Install
npx skills add brycewang-stanford/Awesome-Journal-Skills --skill nejm-study-design --agent claude-code

Same command for any agent — swap --agent for codex, cursor, copilot.

Facts
Files in the skill folder: 1
SKILL.md size: 5 KB
Bundled scripts: none
Path: NEJM-Skills/skills/nejm-study-design/SKILL.md
Open the folder on GitHub →
Where it comes from
Stars: 909 · +31 this week
Language: Stata
Read our review of the source →

Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.

From the SKILL.md

# 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. - Registration must predate enrollment; retrospective registration is generally disqualifying for an Original Article. - The registered **primary outcome** must match the reported primary outcome — discrepancies are a top reviewer flag. > If a trial was never prospectively registered, raise it now. It changes venue and framing and canno

What's inside
Steps it walks through
  1. When to trigger
  2. The non-negotiable: prospective trial registration
  3. Protocol and statistical analysis plan (SAP)
  4. Design rigor checklist (trials)
  5. Observational studies
  6. Operating pass for New England Journal of Medicine
  7. Output format
  8. Anti-patterns
More from Awesome-Journal-Skills
All skills →
About this skill
What does the nejm-study-design skill do?

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.

How do I install it?

Run `npx skills add brycewang-stanford/Awesome-Journal-Skills --skill nejm-study-design --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.

Where does this skill come from?

From brycewang-stanford/Awesome-Journal-Skills, a repository with 909 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.

Is a popular skill a good skill?

Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.

Keep going