Free tool · ProtocolUpdated October 10, 2026

SPIRIT checklist generator: work through the 33 items and get a gap list

Mark each SPIRIT 2013 item as addressed, partly addressed, not yet or not applicable, add a note on where it sits in your protocol, and watch the progress bar move. Copy or print the list of open items to send to your co-authors.

33 numbered items
Progress and gap list
Unofficial helper, nothing stored

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Demo protocol · SPIRIT progress

Addressed

Partly

Not yet

Not applicable

Administrative information (1 to 5)4/5

Introduction and methods (6 to 23)11/18

Ethics, dissemination, appendices (24 to 33)3/10

Demo data. Counts are items marked addressed within each part of the checklist.

SPIRIT in brief

SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) is a guideline for what a trial protocol should contain. The 2013 statement has a 33-item checklist, published by Chan and colleagues in the Annals of Internal Medicine, with a longer explanation and elaboration paper in the BMJ.
It is about content, not format. It does not tell you how to design or run a trial, only what a reader needs to find in the protocol.
Many ethics committees, funders and journals that publish protocols ask for it, and trial registries and protocol papers often use it as a completeness test.
SPIRIT 2025 is a newer update with a 34-item checklist, published in 2025. Check which version your funder or journal expects. This tool follows the 2013 list.
This page is an unofficial helper with paraphrased item titles. Use the original checklist and its explanation paper for the exact wording and for submissions.

Free tool

Check your protocol against SPIRIT 2013

The demo has some items filled in so you can see the gap list. Reset to start your own, mark each item, and add a note with the protocol section. Nothing is saved or sent, so copy the gap list before you leave the page.

Protocol name (used in the gap list)

Show

All 33 itemsOpen items only

18 of 32 complete (56%)7 partial, 7 not yet, 1 not applicable

Administrative information

1. Descriptive title
Design, population, interventions, and acronym if there is one.
2. Trial registration
Registry name and identifier (or intended registry), and the registration data set.
3. Protocol version
Date and version identifier.
4. Funding
Sources and types of financial, material and other support.
5. Roles and responsibilities
Contributors, sponsor contact, role of sponsor and funders, and the committees.

Introduction

6. Background and rationale
Research question, prior evidence on benefits and harms, and why the comparator was chosen.
7. Objectives
Specific objectives or hypotheses.
8. Trial design
Type of trial, allocation ratio and framework (superiority, equivalence, non-inferiority, exploratory).

Methods: participants, interventions, outcomes

9. Study setting
Settings and the list of study sites, and where the data come from.
10. Eligibility criteria
Inclusion and exclusion criteria, and who may select participants or deliver interventions.
11. Interventions
Enough detail to replicate; criteria for changing or stopping; adherence strategies; allowed and prohibited concomitant care.
12. Outcomes
Primary, secondary and other outcomes with measurement, analysis metric, aggregation method and time point, and the justification.
13. Participant timeline
Schedule of enrolment, interventions, assessments and visits, with a diagram.
14. Sample size
How the number was estimated, with the assumptions and the target difference.
15. Recruitment
Strategies to reach the target sample size.

Methods: assignment of interventions

16. Allocation
Sequence generation, allocation concealment mechanism, and who generates and enrols and assigns.
17. Blinding (masking)
Who is blinded after assignment, and when and how unblinding is allowed.

Methods: data collection, management, analysis

18. Data collection methods
Assessment procedures, instrument reliability and validity, and strategies to promote retention and follow-up.
19. Data management
Data entry, coding, security and storage, and quality-promoting steps such as double entry or range checks.
20. Statistical methods
Primary and secondary outcomes, additional analyses, analysis population and handling of missing data.

Methods: monitoring

21. Data monitoring
Composition and role of the data monitoring committee, or why there is none; interim analyses and stopping guidelines.
22. Harms
How adverse events and other unintended effects are collected, assessed, reported and managed.
23. Auditing
Frequency and process of trial conduct audits, and whether they are independent of the sponsor.

Ethics and dissemination

24. Research ethics approval
Plans for seeking ethics committee or IRB approval.
25. Protocol amendments
How changes are communicated to parties such as investigators, committees, registries and participants.
26. Consent or assent
Who obtains it and how, and consent for ancillary studies and use of data or specimens.
27. Confidentiality
How personal information is collected, shared and kept confidential before, during and after the trial.
28. Declaration of interests
Financial and other competing interests of principal investigators and the overall trial.
29. Access to data
Who has access to the final dataset, and any contractual limits.
30. Ancillary and post-trial care
Provisions for care after the trial and compensation for harm caused by participation.
31. Dissemination policy
How results reach participants, professionals and the public; authorship rules; data and code sharing.

Appendices

32. Informed consent materials
Model consent form and other documents given to participants.
33. Biological specimens
Plans for collection, laboratory evaluation and storage for genetic or molecular analysis.

Gap list

SPIRIT 2013 gap list: DEMO-HTN trial protocol v1.0
Complete 18 of 32 applicable items (56%); 7 partly addressed, 7 not yet addressed, 1 not applicable.

[Partial] Item 5. Roles and responsibilities
[Partial] Item 11. Interventions
[Partial] Item 13. Participant timeline
[Open] Item 15. Recruitment
[Partial] Item 18. Data collection methods
[Partial] Item 19. Data management
[Partial] Item 21. Data monitoring
[Open] Item 23. Auditing
[Open] Item 25. Protocol amendments
[Partial] Item 27. Confidentiality
[Open] Item 28. Declaration of interests
[Open] Item 29. Access to data
[Open] Item 30. Ancillary and post-trial care
[Open] Item 31. Dissemination policy

An unofficial helper. It lists the 33 numbered items of the SPIRIT 2013 statement with our own short titles and hints, so the wording is paraphrased; each numbered item has lettered sub-items in the official checklist, so use the original checklist from the SPIRIT Group (and its explanation and elaboration paper) for submissions and read each item in full. SPIRIT 2025 is a newer 34-item update; check which version your funder or journal expects. Not endorsed by the SPIRIT Group. Nothing is stored or sent.

The structure

How the 33 items are organised

Administrative information (items 1 to 5). Title, registration, version, funding, and roles and responsibilities. These are quick to complete and often missed: the version and date, who the sponsor is, what role the funder has in design and analysis, and which committees exist.

Introduction (items 6 to 8). Background and rationale, objectives, and trial design. The rationale item includes why the comparator was chosen, which reviewers look for. The design item asks for the trial type, the allocation ratio and the framework, such as superiority or non-inferiority.

Methods (items 9 to 23). This is the bulk of the checklist and is itself split into participants, interventions and outcomes (9 to 15), assignment of interventions (16 and 17), data collection, management and analysis (18 to 20), and monitoring (21 to 23). Most weak protocols are weak here: outcomes without a time point, sample size without assumptions, randomisation without concealment, or harms without a collection method. Sub-items under several numbers add detail, for example separate points for sequence generation, concealment and implementation under allocation.

Ethics and dissemination (items 24 to 31). Ethics approval, amendments, consent, confidentiality, interests, data access, post-trial care and dissemination. Appendices (items 32 and 33) cover the consent materials and biological specimens.

Where the work usually sits

	Part	Items
Administrative information	1 to 5	Version, funder role, committees
Introduction	6 to 8	Why this comparator
Methods	9 to 23	Outcome time points, concealment, harms
Ethics and dissemination	24 to 31	Data access, post-trial care, sharing
Appendices	32 and 33	Consent materials, specimens

Demo comparison for orientation

About the wording

Licence, paraphrasing and which version to use

The SPIRIT checklist is published by the SPIRIT Group under a Creative Commons licence that, as we understand it, allows sharing with credit and does not allow changed versions. We have not been able to confirm the exact licence terms on the official site from here, so this tool does not copy the official checklist. The item titles and the hints are our own short paraphrases, one line each, and each numbered item covers several lettered sub-items in the original. Treat the tool as a way to track progress, and read the real item text and the explanation and elaboration paper before you tick anything off.

For a trial protocol paper or a funder submission, attach the official checklist with page numbers, not this gap list. If your funder asks for SPIRIT 2025, work from that version instead: it has a 34-item checklist and adds, among other things, open science and patient and public involvement items. The two versions overlap heavily, so most of the work you do against this list carries across.

Write the protocol once, build the study from it

A protocol that covers the SPIRIT items is easier to turn into a study. Upload it in the free sandbox and review the drafted visit schedule and forms.

Start building your study free

From checklist to study build

Where SPIRIT items show up in a working study

A protocol is a plan. These SPIRIT items turn into specific build decisions in the data system.

SPIRIT item	What the protocol states	What you configure
13 Participant timeline	Schedule of enrolment, interventions, assessments, visits	Visit schedule, forms per visit, visit windows
16 and 17 Allocation and blinding	Sequence, concealment, who is blinded	Randomisation setup, blinded roles
18 and 19 Data collection and management	Instruments, retention, entry, coding, quality steps	eCRFs, edit checks, a data validation plan
22 Harms	How adverse events are collected, assessed, reported	AE form and the SAE workflow
26 and 32 Consent	Who obtains consent and how, the consent materials	eConsent template and signature flow
23 Auditing and 25 Amendments	Audits, communication of changes	Audit trail, form draft and approval lifecycle

Capture does not check a protocol against SPIRIT. The table shows where each item lands when you build the study.

In Capture

Use the checklist, then build from the protocol

SPIRIT keeps the protocol complete. Capture helps with the next step: the AI study builder reads the protocol and drafts the visit schedule and forms, and you review them before anything is saved, then test the whole study in a free sandbox.

AI study builder reads a protocol (PDF, DOCX or DOC) and drafts the visit schedule and forms for review.
Edit checks and skip logic implement the data management and quality items.
A field-level audit trail records who changed what, when and why, which supports the auditing and amendment items.
Blank eCRF PDF export for ethics or IRB submissions.

Protocol to study setup

app.capture.study · New study

Using it well

Tips for working through SPIRIT with a team

Work from the full item text

Open the official checklist beside this tool so you tick items against the real wording.

Add the section number as the note

Co-authors can find the item, and the same notes become the page references in the submission.

Use partly addressed honestly

If a sub-item is missing, for example concealment under allocation, leave the item partly addressed.

Mark not applicable with a reason

For example item 33 for a trial with no biological specimens, and say so in the note.

Re-run after each amendment

A changed outcome or analysis can reopen several items at once.

FAQ

Questions teams ask before they switch

Something not covered here? Ask us directly.

What is the SPIRIT checklist?

SPIRIT is a guideline for the content of a clinical trial protocol. The 2013 version is a checklist of 33 items covering administrative information, introduction, methods, ethics and dissemination, and appendices. It was published in the Annals of Internal Medicine in 2013, with an explanation and elaboration paper in the BMJ.

How many items are on the SPIRIT checklist?

The 2013 checklist has 33 numbered items, several with lettered sub-items. The SPIRIT 2025 update has 34 items.

What is the difference between SPIRIT and CONSORT?

SPIRIT covers what a trial protocol should contain, written before the trial starts. CONSORT covers how to report the results of a randomised trial. The two were developed to align, so protocol items map to report items. See the CONSORT flow diagram generator for the reporting side.

Is the SPIRIT checklist free to use?

It is published by the SPIRIT Group under a Creative Commons licence with no-derivatives terms, so you can share the original with credit but should not alter it. We have not confirmed the exact terms on the official site, so read them there. This tool uses paraphrased titles and does not reproduce the official wording.

Do I have to use SPIRIT 2025 instead of 2013?

It depends on who you are submitting to. SPIRIT 2025 is the update and has 34 items. Some funders and journals may still accept the 2013 version, so check their instructions.

Does SPIRIT apply to all trials?

It is written for protocols of clinical trials generally and focuses on content rather than format. Extensions exist for particular designs and topics, and the 2025 update is described as a guideline for protocols of randomised trials.

Is anything stored or sent?

No. Your marks and notes stay in your browser and are lost when you close the page, so copy or print the gap list first.

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Turn a complete protocol into a working study

Upload your protocol, review the drafted schedule and forms, and test them in a free sandbox. No credit card, pay only when you go live.