SPIRIT 2025 Statement: Defining standard protocol items for clinical trials

Reporting guidelines are recommendations to help write up research clearly.

Your research will be used by people from different disciplines and backgrounds for decades to come. Reporting guidelines are community-created recommendations for describing what you did and what you found so that everyone can understand, repeat, apply, and synthesise your work. Although they recommend information to include in your manuscript, they don’t dictate how to order that information.

Most reporting guidelines consist of the full guidance (sometimes called an Explanation and Elaboration document) and a checklist. The full guidance provides detailed explanations and examples for each item, and the checklist allows you to demonstrate adherence to editors.

You can use reporting guidelines throughout your research process. However you use reporting guidelines, please cite them.

Writing manuscripts

Write confidently using a reporting guideline to quickly turn a blank page into a thorough and impactful manuscript.

Checking

Use a reporting checklist to demonstrate to an editor or peer reviewer that you have included everything. Many journals require completed checklists at submission.

Writing applications

Reporting guidelines can help you write funding applications, ethics applications, and protocols, but they won’t make design decisions for you!

Reporting guidelines are neither design nor quality appraisal tools.

Although reporting guidelines recommend information to include when writing up research, they do not mandate how to design research. Similarly, when reviewing literature, although you can use reporting guidelines to assess whether a manuscript is well reported, you cannot use them to appraise whether that study is well designed.

Key information

Reporting guideline acronym

SPIRIT

Provided for

Defining standard protocol items for clinical trials

Relevant URLs (full-text if available)

PubMed ID

Downloads

Bibliographic reference

Commonly used reporting guidelines

STROBE Observational Studies
PRISMA Systematic reviews of trials
PRISMA-P Systematic review protocols
CONSORT Randomised trials
SPIRIT Randomised trial protocols
SRQR Qualitative Research
CARE Case Reports
STARD Diagnostic studies
TRIPOD+AI Prediction Models
ARRIVE Animal Research
SQUIRE Quality Improvement
CHEERS Economic Evaluations
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Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hróbjartsson A.  SPIRIT 20205 statement: updated guideline for protocols of randomized trials.

This guideline was published simultaneously in 5 journals. You can read the guideline in any of these journals using the links below.
BMJ. 2025; 388:e081660. PMID:40294956
JAMA. 2025.PMID: 40294593
Lancet 2025.
Nat Med. 2025.PMID: 40295741
PLoS Med. 2025; 22(4): e1004587.PMID: 40294521

Additional information

Language

English

Availability in additional languages

Study design

  • Clinical trials
  • Experimental studies
  • Study protocols

Clinical area

  • No clinical specialty specified

Applies to the whole report or to individual sections of the report?

  • Protocol-whole report

Reporting guideline website URL

Previous versions of this guideline / Guideline history

SPIRIT 2013

Other

Additional Information