Methods. The SPIRIT-AI and CONSORT-AI extensions were simultaneously developed for clinical trial protocols and trial reports. An announcement for the SPIRIT-AI and CONSORT-AI initiative was published in October 2019, 27 and the two guidelines were registered as reporting guidelines under development on the EQUATOR library of reporting guidelines in May 2019. The SPIRIT 2013 Statement provides recommendations for a minimum set of scientific, ethical, and administrative elements that should be addressed in a clinical trial protocol. The Statement also details the scope and systematic development methods of the SPIRIT guidance. The recommendations are outlined in a 33-item checklist and figure. The SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials) contains guidance for authors of protocols for randomized and nonrandomized clinical trials. The SPIRIT statement published in 2013 provides minimum guidance applicable for all clinical trial interventions but recognizes that certain interventions may require extension or elaboration of these items1,2. AI is an area of enormous interest, with strong drivers to accelerate new interventions through to publication, implementation and market6. The CONSORT (Consolidated Standards of Reporting Trials) 3 and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 4 statements are minimum reporting guidelines for This advice is relevant to protocols of clinical trials, and is based on the SPIRIT guidelines. Professional medical writers are sometimes hired to improve clarity and structure in a trial report, and guidelines for ethical collaborative writing have been developed.391 392 Because the drafting of text can influence how the study results and The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating Plans for assessment and collection of outcome, baseline, and other trial data, including any related processes to promote data quality (eg, duplicate measurements, training of assessors) and a description of study instruments (eg, questionnaires, laboratory tests) along with their reliability and validity, if known. To assess the quality of reporting of RCT protocols approved by UK research ethics committees before and after the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline. We had access to RCT study protocols that received ethical approval in the UK in 2012 (n=103) and 2016 (n=108). From those, we assessed the adherence to the 33 SPIRIT items (i The SPIRIT recommendations are intended as a guide for those preparing the full protocol for a clinical trial. A clinical trial is a prospective study in which one or more interventions are assigned to human participants in order to assess the effects on health related outcomes. The rapidly growing use of artificial intelligence in pathology presents a challenge in terms of study reporting and methodology. The existing guidelines for the design (SPIRIT) and reporting (CONSORT) of clinical trials have been extended with the aim of ensuring production of the highest quality evidence in this field.