SPIRIT 2025 is a reporting standard for protocols of randomized trials. The guideline, maintained jointly with CONSORT, describes what information a study protocol should contain so that the planned investigation can be professionally assessed before its commencement. It thus targets the protocol document and not the subsequent publication of results.<\/p>\n
A protocol is the binding description of what is planned in a clinical study: research question, participants, interventions, comparison, endpoints, timeline, and analysis approach. SPIRIT 2025 does not prescribe a specific study from these areas but provides a minimum framework for their presentation. The guideline helps authors compile the planned procedures into a complete protocol report.<\/p>\n
The current version was published in 2025 and builds upon SPIRIT 2013. The associated materials include a checklist, a figure, and an explanatory document. In the sources, the guideline is described as a standard for protocols of randomized trials; it is further developed in conjunction with the CONSORT guidelines.<\/p>\n
SPIRIT requires that the scientific rationale and objectives of the study be clearly distinguished from the procedures. The protocol must include, among other things, inclusion criteria, recruitment, description of study arms, endpoints, data collection, data management, monitoring, and statistical analysis. The handling of protocol amendments also belongs within this planning framework.<\/p>\n
For a randomized design, information on the generation of the allocation sequence, concealment of allocation, and implementation of randomization is particularly important. Depending on the study, the protocol must also explain whether and how participants, investigators, or assessors are blinded. The reporting guideline ensures that such design decisions are not scattered or left unstated in the document.<\/p>\n
SPIRIT 2025 and CONSORT 2025 refer to the same study type but to different documents. SPIRIT concerns the prospective plan of a randomized trial. CONSORT concerns the manuscript after study completion and requires information on actual participant flow, actual analyses, and results.<\/p>\n
The existing glossary entry ‘clinical trial protocol’ refers to the specific study protocol as a document. SPIRIT 2025, in contrast, is the standard that can be used for reporting on the content of this document. It does not replace the sponsor’s approval of the clinical trial protocol nor the approval by authorities and ethics committees.<\/p>\n
Furthermore, ICH M11 is to be distinguished from SPIRIT 2025. The guideline, adopted at Step 4 in November 2025, describes, together with a template and a technical specification, the format and structure of the protocol document, i.e., table of contents, common headings, content instructions, and data elements for interoperable electronic exchange. SPIRIT, on the other hand, is a reporting guideline to ensure that the planned content is fully reported, and does not define a regulatorily harmonized document format. Both can be used together: the checklist for completeness review, the template for formal structuring.<\/p>\n
The protocol is also the place where the handling of adverse events, data access, and retention is defined before the first visit. SPIRIT clarifies that not only the medical intervention but also the governance of the study must be described. This includes responsibilities, monitoring of study progress, and rules for amendments. This content helps investigators and ethics committees assess the planned study as a whole, rather than just its medical hypothesis.<\/p>\n
A SPIRIT checklist is particularly helpful when the clinical trial protocol references multiple documents. In such cases, the protocol must clearly indicate which information is contained within it and which is supplemented by references to the analysis plan, safety plan, or manual. The standard does not require a uniform format for these appendices. Its aim is to ensure that their role and connection to the study plan remain unambiguous for expert readers.<\/p>\n
The use of the standard also promotes comparison between registered information and the subsequent study publication. If endpoints, target population, or recruitment target are precisely described, deviations in the results report can be specifically identified. SPIRIT thus does not compel an unchangeable study plan: protocol amendments may be scientifically necessary. However, they must remain recognizable as changes to a previously described plan and be incorporated into further study documentation.<\/p>\n
A clinical trial protocol structured according to SPIRIT facilitates the use of the same terms for endpoints, visits, study population, and evaluation in subsequent study documents. Especially in multi-center trials, an unclear description of the intervention, visit schedules, or discontinuation criteria can lead to inconsistent procedures. Protocol review must therefore interpret medical, statistical, and operational information as a coherent plan.<\/p>\n
Full-service CROs like Mediconomics support SPIRIT 2025 by coordinating the clinical trial protocol, synopsis, informed consent documents, EDC concept, and statistical analysis plan. Regulatory Affairs checks whether protocol-relevant information is consistent for submission, while Clinical Operations assesses the feasibility of recruitment, visits, and safety pathways. Medical Writing can specifically use the SPIRIT checklist for a gap analysis of the protocol draft.<\/p>\n
Does SPIRIT 2025 apply to the final study manuscript?<\/strong><\/p>\n No. CONSORT is authoritative for the results report of a randomized trial. SPIRIT accompanies the presentation of what was planned in the protocol before the study began.<\/p>\n Does SPIRIT determine the endpoints of a study?<\/strong><\/p>\n The guideline does not determine medically or statistically appropriate endpoints. It requires that the chosen endpoints be sufficiently described in the protocol.<\/p>\n Is a SPIRIT checklist item a regulatory approval?<\/strong><\/p>\n No. The checklist is a reporting standard. Approvals and GCP-compliant conduct follow the respective applicable legal and ethical requirements.<\/p>\n SPIRIT 2025 is a reporting standard for protocols of randomized trials. The guideline, maintained jointly with CONSORT, describes what information a study protocol should contain so that the planned investigation can be professionally assessed before its commencement. It thus targets the protocol document and not the subsequent publication of results. Focus on Protocols of Randomized […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[29],"class_list":["post-8186","glossary","type-glossary","status-publish","hentry","glossary-cat-medical-writing-transparenz"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/8186","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":0,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/8186\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=8186"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=8186"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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