SPIRIT 2025 for Grant-Funded Trials: What Changed from SPIRIT 2013, Item by Item, and Where It Goes in a Grant Application
SPIRIT 2025 added an open-science section, patient and public involvement and trial monitoring. What changed from 2013, and how to map each protocol item into a trial grant.
- Items
- 34 (SPIRIT 2013: 33)
- New items
- PPI (11), trial monitoring (29)
- New section
- Open science, items 4–8
- Published
- 28 April 2025, five journals
Quick answer
- SPIRIT 2025 has 34 minimum protocol items: 2 added, 5 revised, 5 deleted or merged since 2013.
- The new open-science section and PPI item overlap with what funders ask for in data and involvement plans.
- Map every item to a grant section so protocol, methods and budget agree.
01Why SPIRIT 2025 matters for a grant application
Trial grant reviewers judge whether a study is justified, sound, ethical and deliverable, and they read the methods as a protocol in miniature. SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) defines the minimum content of a clinical trial protocol [1]. It is a reporting guideline, not a funding template, but a proposal that already covers its items leaves reviewers fewer gaps to find.
SPIRIT 2025 was published on 28 April 2025, simultaneously in the BMJ, JAMA, The Lancet, Nature Medicine and PLOS Medicine [1, 2], two weeks after CONSORT 2025 [4]. The two guidelines now share an aligned structure, so the protocol you cost in a grant application maps onto the results paper you will later report.
02What changed from SPIRIT 2013
The 2013 statement had a 33-item protocol checklist [3]. SPIRIT 2025 has 34 minimum items: two added, five revised and five deleted or merged [1].
| Change | Detail |
|---|---|
| Item count | 33 items (2013) → 34 minimum items (2025) |
| New items | Item 11: patient and public involvement in design, conduct and reporting. Item 29: trial monitoring, replacing the auditing item |
| New section | Open science, items 4–8: trial registration (4), access to protocol and statistical analysis plan (5), sharing of de-identified participant data (6), funding and conflicts of interest (7), dissemination policy (8) |
| Revised | Five items revised, with guidance integrated from related reporting guidelines on harms, outcomes and intervention description |
| Deleted or merged | Five items, including auditing and the appendix items on consent materials and biological specimens; data access merged into data management, authorship and professional writers into dissemination |
Two changes matter most to grant writers. The open-science section turns registration, protocol and SAP access, data sharing and conflicts of interest into protocol content, which overlaps with what funders ask for in a data management plan. The patient and public involvement item asks for PPI that is planned, not added afterwards [1]. Confirm every item number and its wording against the published checklist; do not rely on secondary summaries, including this one, in a submitted protocol.
03Building an item-by-item crosswalk
A crosswalk records, for each item, how the requirement changed and where the proposal addresses it. Complete one row for every item of the official checklist; Table 2 shows the structure.
| SPIRIT 2025 domain | Status vs 2013 | Where it goes in the grant | Evidence reviewers look for |
|---|---|---|---|
| Open science (items 4–8) | New section | Data management plan; dissemination | Registry, protocol and SAP access, data-sharing statement |
| Patient and public involvement (item 11) | New | Methods; impact | Named partners, roles and timing |
| Trial monitoring (item 29) | New | Governance; risk; budget | Who monitors, how often, and what it costs |
| Harms | Strengthened | Safety and data monitoring plan | Defined harms, timing, reporting route |
| Interventions and comparators | Revised | Trial design; work packages | Delivery, dose, adherence, comparator detail |
| Outcomes | Revised | Methods; statistical plan | Measure, metric, time point, aggregation |
04Mapping protocol elements into the grant
Each protocol domain has a natural home in most clinical trial applications (Table 3). Map them explicitly so the protocol and the proposal never disagree on trial design, outcome measures or randomisation. Then connect each component to work packages, costs and deliverables: the data monitoring committee and trial monitoring visits should appear in the methods and in the budget. The statistical analysis plan should match the analysis the grant promises.
| Protocol domain | Key content | Typical grant section |
|---|---|---|
| Administrative and open science | Title, sponsor, investigators, registration, data sharing | Cover sheet; summary; data management plan |
| Scientific rationale | Background evidence, objectives, hypotheses | Background; aims |
| Trial design | Setting, eligibility, allocation, intervention, comparator, follow-up | Methods; work packages |
| Outcome measures | Primary and secondary outcomes, instruments, time points | Methods; evaluation plan |
| Statistical methods | Sample size, randomisation, concealment, blinding, analysis | Methods; statistics annex |
| Oversight | Data monitoring, trial monitoring, research ethics, consent | Ethics; risk; governance; budget |
05A practical checklist audit
- The SPIRIT version used is named and cited.
- Every applicable item is addressed, or its non-applicability explained.
- Outcome measures are defined with time points.
- Randomisation, allocation concealment and blinding are reproducible.
- Sample-size logic is transparent and the analysis matches the design.
- Safety, data monitoring and trial monitoring roles are clear, and data protection is covered.
- Protocol, timeline and budget agree with one another.
- Funder instructions on uploading the protocol or checklist are followed.
SPIRIT supports completeness; it does not replace research ethics review, prospective trial registration, clinical trial legislation or scheme-specific rules.
Questions
How many items does SPIRIT 2025 have?
Does SPIRIT replace the grant application template?
Is SPIRIT the same as CONSORT?
Can items be marked as not applicable?
References
- Chan AW, Boutron I, Hopewell S, et al. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ. 2025;389:e081477. https://doi.org/10.1136/bmj-2024-081477
- Chan AW, Boutron I, Hopewell S, et al. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. PLoS Med. 2025;22(4):e1004589. https://doi.org/10.1371/journal.pmed.1004589
- Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200-207. https://doi.org/10.7326/0003-4819-158-3-201302050-00583
- Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ. 2025;389:e081123. https://doi.org/10.1136/bmj-2024-081123
Update log
- Published by Pubrica
How to cite this article
Dr. Charlie. (2026, November 5). SPIRIT 2025 for Grant-Funded Trials: What Changed from SPIRIT 2013, Item by Item, and Where It Goes in a Grant Application. Pubrica. https://pubrica.com/academy/grant-writing/spirit-2025-grant-funded-trials/
This article is general information for researchers, not legal, regulatory or funding advice. Check the current requirements of your journal, funder, ethics committee or regulator before you act on it.
