All reporting guidelines
Check your protocol against SPIRIT.
- Guideline
- SPIRIT 2025
- Items
- 34
- Criteria
- 53
- Sections
- 9
- Applies to
- trial protocol
A checklist of what a randomised trial protocol must include. SPIRIT is the protocol-stage counterpart of CONSORT.
Expected by many ethics committees, funders and protocol-publishing journals.
SPIRIT 2025 · Standard Protocol Items: Recommendations for Interventional Trials
What comes back53 criteria
Showing all 53 criteria.
Administrative information
- Title and structured summary1aTitle and structured summary1aTitle stating the trial design, population, and interventions, with identification as a protocol
- 1b1bStructured summary of trial design and methods, including items from the World Health Organization Trial Registration Data Set
- Protocol version2Protocol version2Version date and identifier
- Roles and responsibilities3aRoles and responsibilities3aNames, affiliations, and roles of protocol contributors
- 3b3bName and contact information for the trial sponsor
- 3c3cRole of trial sponsor and funders in design, conduct, analysis, and reporting of trial; including any authority over these activities
- 3d3dComposition, roles, and responsibilities of the coordinating site, steering committee, endpoint adjudication committee, data management team, and other individuals or groups overseeing the trial, if applicable
Open science
- Trial registration4Trial registration4Name of trial registry, identifying number (with URL), and date of registration. If not yet registered, name of intended registry
- Protocol and statistical analysis plan5Protocol and statistical analysis plan5Where the trial protocol and statistical analysis plan can be accessed
- Data sharing6Data sharing6Where and how the individual de-identified participant data (including data dictionary), statistical code, and any other materials will be accessible
- Funding and conflicts of interest7aFunding and conflicts of interest7aSources of funding and other support (e.g., supply of drugs)
- 7b7bFinancial and other conflicts of interest for principal investigators and steering committee members
- Dissemination policy8Dissemination policy8Plans to communicate trial results to participants, healthcare professionals, the public, and other relevant groups (e.g., reporting in trial registry, plain language summary, publication)
Introduction
- Background and rationale9aBackground and rationale9aScientific background and rationale, including summary of relevant studies (published and unpublished) examining benefits and harms for each intervention
- 9b9bExplanation for choice of comparator
- Objectives10Objectives10Specific objectives related to benefits and harms
Methods: patient and public involvement, trial design
- Patient and public involvement11Patient and public involvement11Details of, or plans for, patient or public involvement in the design, conduct, and reporting of the trial
- Trial design12Trial design12Description of trial design including type of trial (e.g., parallel group, crossover), allocation ratio, and framework (e.g., superiority, equivalence, non-inferiority, exploratory)
Methods: participants, interventions, and outcomes
- Trial setting13Trial setting13Settings (e.g., community, hospital) and locations (e.g., countries, sites) where the trial will be conducted
- Eligibility criteria14aEligibility criteria14aEligibility criteria for participants
- 14b14bIf applicable, eligibility criteria for sites and for individuals who will deliver the interventions (e.g., surgeons, physiotherapists)
- Intervention and comparator15aIntervention and comparator15aIntervention and comparator with sufficient details to allow replication including how, when, and by whom they will be administered. If relevant, where additional materials describing the intervention and comparator (e.g., intervention manual) can be accessed
- 15b15bCriteria for discontinuing or modifying allocated intervention/comparator for a trial participant (e.g., drug dose change in response to harms, participant request, or improving/worsening disease)
- 15c15cStrategies to improve adherence to intervention/comparator protocols, if applicable, and any procedures for monitoring adherence (e.g., drug tablet return, sessions attended)
- 15d15dConcomitant care that is permitted or prohibited during the trial
- Outcomes16Outcomes16Primary and secondary outcomes, including the specific measurement variable (e.g., systolic blood pressure), analysis metric (e.g., change from baseline, final value, time to event), method of aggregation (e.g., median, proportion), and time point for each outcome
- Harms17Harms17How harms are defined and will be assessed (e.g., systematically, non-systematically)
- Participant timeline18Participant timeline18Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and visits for participants. A schematic diagram is highly recommended
- Sample size19Sample size19How sample size was determined, including all assumptions supporting the sample size calculation
- Recruitment20Recruitment20Strategies for achieving adequate participant enrolment to reach target sample size
Methods: assignment of interventions
- Randomisation: sequence generation21aRandomisation: sequence generation21aWho will generate the random allocation sequence and the method used
- 21b21bType of randomization (simple or restricted) and details of any factors for stratification. To reduce predictability of a random sequence, other details of any planned restriction (e.g., blocking) should be provided in a separate document that is unavailable to those who enroll participants or assign interventions
- Allocation concealment mechanism22Allocation concealment mechanism22Mechanism used to implement the random allocation sequence (e.g., central computer/telephone; sequentially numbered, opaque, sealed containers), describing any steps to conceal the sequence until interventions are assigned
- Implementation23Implementation23Whether the personnel who will enroll and those who will assign participants to the interventions will have access to the random allocation sequence
- Blinding24aBlinding24aWho will be blinded after assignment to interventions (e.g., participants, care providers, outcome assessors, data analysts)
- 24b24bIf blinded, how blinding will be achieved and description of the similarity of interventions
- 24c24cIf blinded, circumstances under which unblinding is permissible, and procedure for revealing a participant's allocated intervention during the trial
Methods: data collection, management, and analysis
- Data collection methods25aData collection methods25aPlans for assessment and collection of trial data, including any related processes to promote data quality (e.g., duplicate measurements, training of assessors) and a description of trial instruments (e.g., questionnaires, laboratory tests) along with their reliability and validity, if known. Reference to where data collection forms can be accessed, if not in the protocol
- 25b25bPlans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols
- Data management26Data management26Plans for data entry, coding, security, and storage, including any related processes to promote data quality (e.g., double data entry; range checks for data values). Reference to where details of data management procedures can be accessed, if not in the protocol
- Statistical methods27aStatistical methods27aStatistical methods used to compare groups for primary and secondary outcomes, including harms
- 27b27bDefinition of who will be included in each analysis (e.g., all randomized participants), and in which group
- 27c27cHow missing data will be handled in the analysis
- 27d27dMethods for any additional analyses (e.g., subgroup and sensitivity analyses)
Methods: monitoring
- Data monitoring committee28aData monitoring committee28aComposition of data monitoring committee (DMC); summary of its role and reporting structure; statement of whether it is independent from the sponsor and funder; conflicts of interest and reference to where further details about its charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not needed
- 28b28bExplanation of any interim analyses and stopping guidelines, including who will have access to these interim results and make the final decision to terminate the trial
- Trial monitoring29Trial monitoring29Frequency and procedures for monitoring trial conduct. If there is no monitoring, give explanation
Ethics
- Research ethics approval30Research ethics approval30Plans for seeking research ethics committee/institutional review board approval
- Protocol amendments31Protocol amendments31Plans for communicating important protocol modifications to relevant parties
- Consent or assent32aConsent or assent32aWho will obtain informed consent or assent from potential trial participants or authorized proxies, and how
- 32b32bAdditional consent provisions for collection and use of participant data and biological specimens in ancillary studies, if applicable
- Confidentiality33Confidentiality33How personal information about potential and enrolled participants will be collected, shared, and maintained in order to protect confidentiality before, during, and after the trial
- Ancillary and post-trial care34Ancillary and post-trial care34Provisions, if any, for ancillary and post-trial care, and for compensation to those who suffer harm from trial participation
SPIRIT 2025 checklist items reproduced from the published guideline. Chan A-W, Boutron I, Hopewell S, Moher D, Schulz KF, et al. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ 2025;389:e081477. CC BY 4.0.
What comes back
See one item in fullThe same form, marked against your own protocol.
The sample above is an illustration. On your protocol, all 53 criteria come back marked, and the ones that fall short raise a mark in the margin of the paper itself.
- Met, partly met, not met or not applicable, for every item
- Each item highlighted in your text, ready to amend
- What is missing, how to fix it, and where in the paper it belongs
- The whole form, downloadable as a marked spreadsheet
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