SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) is the reporting checklist for what a clinical trial protocol must contain, not for how the trial’s results are written up afterward. Where CONSORT checks a finished trial report, SPIRIT checks the protocol itself — the document an IRB/ethics committee, a sponsor’s quality system, and (once registered) the public will use to judge whether a trial is well designed and complete before it enrolls a single participant. The current version, SPIRIT 2025, updates the original 2013 statement and expands the checklist from 33 to 34 items.
SPIRIT and CONSORT are maintained as a linked family by the same core group and are now published from a single site, consort-spirit.org (the older consort-statement.org domain now redirects there). Both are catalogued as reporting guidelines by the EQUATOR Network, alongside PRISMA for systematic reviews and STROBE for observational studies.
SPIRIT checklist quick-reference table
SPIRIT organizes its 34 items into the same broad sections a full clinical trial protocol already needs, which is why journals, funders, and many IRBs ask authors to submit a completed SPIRIT checklist alongside — or cross-referenced within — the protocol itself.
| Section | What it covers | Typical protocol location |
|---|---|---|
| Administrative information | Title, trial registration data set, protocol version/date, funding, roles and responsibilities of the sponsor, steering committee, and other named parties | Title page, front matter |
| Introduction | Background and rationale for the trial (including the evidence for choice of comparators), and the specific objectives or hypotheses | Background/Introduction |
| Methods: Participants, interventions, and outcomes | Study setting, eligibility criteria, the interventions for each group (and any planned modifications), primary/secondary outcomes, participant timeline, sample size, and recruitment strategy | Study Design / Population / Interventions / Outcomes |
| Methods: Assignment of interventions | Sequence generation, allocation concealment, implementation, and blinding (masking) — how and when unblinding is permitted | Randomization & Blinding |
| Methods: Data collection, management, and analysis | Outcome measurement plans, retention strategies, data management, and the statistical analysis plan, including interim analyses and stopping guidelines | Data Management / Statistical Analysis Plan |
| Methods: Monitoring | Data monitoring committee/DSMB role, harms reporting and management, auditing | Safety Monitoring |
| Ethics and dissemination | Research ethics approval, protocol amendments, informed consent, confidentiality, access to data, ancillary/post-trial care, dissemination policy | Ethics / Consent / Publication Policy |
| Appendices | Informed consent materials, biological specimen handling (collection, storage, destruction) | Appendices |
This table groups the checklist by section for orientation; it is not a substitute for the numbered 34-item checklist itself. Download the current editable checklist, expanded checklist, and participant-timeline figure template directly from consort-spirit.org before completing a submission — item wording and numbering should always be checked against that primary document, not reconstructed from a summary.
SPIRIT 2025 vs. SPIRIT 2013: what changed
SPIRIT 2013 (Chan, Tetzlaff, Altman, Moher, and colleagues) was the original statement, published simultaneously in Annals of Internal Medicine and the BMJ, with a 33-item checklist and an accompanying explanation and elaboration paper. SPIRIT 2025 statement: updated guideline for protocols of randomised trials — led by many of the same authors (Chan, Boutron, Hopewell, Moher, Schulz, Collins, and co-authors) — was co-published in 2025 in the BMJ (doi:10.1136/bmj-2024-081477), The Lancet, and PLOS Medicine (doi:10.1371/journal.pmed.1004589), as part of the same coordinated multi-journal release that carried the companion CONSORT 2025 statement (which also appeared in JAMA and Nature Medicine). A SPIRIT 2025 explanation and elaboration paper was published alongside it in the BMJ (doi:10.1136/bmj-2024-081660).
The headline change is the expansion from 33 to 34 items. As with the CONSORT 2025 update, the revision reflects a decade of accumulated evidence on protocol reporting gaps — the sister CONSORT 2025 update added new open-science, harms, and conflict-of-interest content, and SPIRIT’s parallel revision brings its own checklist into alignment with that same current thinking on what a trustworthy trial record needs to disclose up front, at the protocol stage, rather than only after results are reported. Sponsors, CROs, and investigators who built protocol templates against SPIRIT 2013 should treat any protocol drafted or substantially revised from 2025 onward as needing a check against the current 34-item version, the same way CONSORT 2025 superseded CONSORT 2010 for trial reports.
Why SPIRIT exists: the protocol, not the results paper
Incomplete or ambiguous trial protocols are a well-documented driver of downstream problems: unregistered or undisclosed outcome switching, ambiguous eligibility criteria that different sites interpret differently, and statistical analysis plans that are written (or finalized) only after data collection has started. SPIRIT was developed specifically to close this gap by defining the minimum content a protocol should contain — not what a study should find, only what a reader needs to be told in order to evaluate the trial’s design, conduct, and pre-specified analysis before it happens.
That distinction matters operationally. CASRAI’s guide to designing a clinical trial protocol covers protocol structure under ICH E6 and ICH E8; ICH M11 is a harmonized template and machine-readable technical specification for the protocol document itself. SPIRIT is neither of those — it is a reporting-completeness checklist, the same role CONSORT plays for trial reports and PRISMA plays for systematic reviews. A sponsor can use ICH M11’s template to structure the document and still use SPIRIT as an independent completeness check, and many journals, funders, and some IRBs now expect exactly that: a completed SPIRIT checklist submitted alongside the protocol, with a page/section reference for each item.
Who requires a SPIRIT checklist, and when
- Protocol publication. Journals that publish standalone trial protocols (a growing practice, especially for publicly funded trials) commonly require a completed SPIRIT checklist as a condition of peer review, the same way a results paper requires a CONSORT checklist.
- Funders. Some funders — particularly those that require open, prospective registration of trial design — reference SPIRIT (directly or via the EQUATOR Network) in their protocol-writing guidance, even where it isn’t a hard submission requirement.
- Ethics committees and IRBs. Some institutions use the SPIRIT checklist internally as a protocol-completeness review aid, distinct from the substantive risk/benefit review the committee itself performs.
- Systematic reviewers and methodologists use SPIRIT compliance as one marker of protocol quality when appraising a trial’s registration or published protocol.
None of this replaces registration itself — SPIRIT is a content-completeness checklist, not a registry. Prospective trial registration is a separate obligation with its own timing rules.
How SPIRIT fits with CONSORT, ICH M11, and IRB protocol-writing guidance
| Document | Governs | Applies to | CASRAI guide |
|---|---|---|---|
| SPIRIT 2025 | Minimum content a trial protocol must report | Protocol, before enrollment | This page |
| CONSORT 2025 | Minimum content a trial results report must contain | Manuscript, after trial completion | CONSORT checklist guide |
| ICH M11 (CeSHarP) | Standardized template, headings, and machine-readable structure for the protocol document | Protocol, before enrollment | ICH M11 guide |
| ICH E6 / ICH E8 | Good Clinical Practice principles and general considerations informing protocol content | Protocol design and trial conduct | Protocol design guide |
| IRB protocol narrative | Institution-specific human-subjects review submission, often overlapping with but not identical to the SPIRIT-covered protocol | Ethics/IRB submission | IRB protocol guide |
In practice, a sponsor typically drafts the protocol against ICH M11’s template (or an equivalent house template built on ICH E6/E8), then runs the finished document through the SPIRIT checklist as a completeness check before submission to a journal, funder, or ethics committee — much as an author runs a finished manuscript through CONSORT before submitting a results paper. The statistical mechanics of endpoints, sample size, and the statistical analysis plan that SPIRIT’s data-analysis items reference are covered in more depth in that companion guide.
Completing a SPIRIT checklist: a practical workflow
- Draft the protocol first, using ICH M11’s template or an equivalent institutional/sponsor template built around ICH E6/E8 principles.
- Download the current SPIRIT 2025 checklist (editable Word document) directly from consort-spirit.org — do not reuse a SPIRIT 2013 checklist held over from an older template.
- Work item by item, recording the specific page and section number in the protocol where each item is addressed. A “not applicable” designation should be justified, not left blank.
- Check the participant timeline figure requirement — SPIRIT recommends a schedule-of-enrollment/interventions/assessments figure (often called a SPIRIT figure) mapping study visits against the interventions and assessments performed at each; consort-spirit.org provides a template for this.
- Submit the completed checklist alongside the protocol to the target journal, funder, or ethics committee, following whichever submission’s specific formatting instructions apply.
- Re-run the check after any substantive protocol amendment — a checklist completed against an early draft can go stale once eligibility criteria, outcomes, or the statistical analysis plan change.
Frequently asked questions
Is SPIRIT the same as the SPIRIT statement or the SPIRIT checklist?
Yes — “the SPIRIT statement” refers to the full guideline paper, and “the SPIRIT checklist” refers to the 34-item table extracted from it that authors complete and submit. Both terms describe the same guideline; the checklist is the working document, the statement is the journal article that defines and justifies it.
Does SPIRIT apply to trials other than randomized controlled trials?
SPIRIT was developed with interventional trials — most centrally randomized controlled trials — in mind, and its item set (randomization, blinding, allocation concealment) is written from that perspective. A number of SPIRIT extensions exist for specific trial types and features (for example, trials involving traditional and complementary medicine, or specific outcome-reporting needs); check consort-spirit.org and the EQUATOR Network’s guideline library for the extension that matches an atypical design before defaulting to the base checklist alone.
Is a completed SPIRIT checklist the same thing as trial registration?
No. Trial registration is a separate, typically legally or institutionally required step (for example, registering on ClinicalTrials.gov before enrollment) with its own data fields and timing rules. A SPIRIT checklist documents the completeness of the protocol narrative; it does not itself register the trial anywhere.
Who is expected to complete the SPIRIT checklist — the sponsor, the investigator, or the biostatistician?
SPIRIT does not assign the task to a specific role; in practice it is usually completed by whoever authors or coordinates the protocol (often the sponsor’s medical writer, protocol lead, or the principal investigator on an investigator-initiated trial), with input from the biostatistician on the data-analysis and monitoring items and from regulatory/quality staff on the administrative and ethics items.
Does using ICH M11’s template automatically satisfy SPIRIT?
Not automatically, though there is substantial overlap — both were developed to improve protocol completeness and share many content expectations. ICH M11 standardizes structure and headings; SPIRIT is a completeness checklist. Running a completed SPIRIT check against an ICH M11-structured protocol is still worthwhile, since SPIRIT can surface a gap (for example, an under-specified stopping rule or an unclear analysis population definition) that a template’s heading alone does not guarantee has been filled in substantively.
Last verified 2026-08-16 against consort-spirit.org (primary source for the 34-item SPIRIT 2025 checklist) and EuropePMC records for the SPIRIT 2025 statement and explanation-and-elaboration papers. Journal co-publication details for SPIRIT 2025 beyond BMJ, The Lancet, and PLOS Medicine were not independently re-confirmed this session; verify against consort-spirit.org before citing further specifics such as exact publication dates.
