The SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials) is an international initiative aimed at improving the quality and completeness of clinical trial protocols. The statement provides a checklist of recommended items to include in a clinical trial protocol, covering aspects such as administrative information, background and rationale, objectives, trial design, participants, interventions, and outcomes. The accompanying Explanation and Elaboration (E&E) paper offers detailed explanations, rationale, and model examples for each checklist item, along with relevant references. The E&E paper is designed to be used in conjunction with the SPIRIT Statement to help drafters create transparent and comprehensive protocols. Key elements addressed include trial registration, funding sources, roles and responsibilities, study design, eligibility criteria, interventions, and modifications. The SPIRIT 2013 Statement and E&E paper reflect the input of 115 contributors and are intended to guide trial investigators, reviewers, and stakeholders in ensuring the integrity and transparency of clinical trials.The SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials) is an international initiative aimed at improving the quality and completeness of clinical trial protocols. The statement provides a checklist of recommended items to include in a clinical trial protocol, covering aspects such as administrative information, background and rationale, objectives, trial design, participants, interventions, and outcomes. The accompanying Explanation and Elaboration (E&E) paper offers detailed explanations, rationale, and model examples for each checklist item, along with relevant references. The E&E paper is designed to be used in conjunction with the SPIRIT Statement to help drafters create transparent and comprehensive protocols. Key elements addressed include trial registration, funding sources, roles and responsibilities, study design, eligibility criteria, interventions, and modifications. The SPIRIT 2013 Statement and E&E paper reflect the input of 115 contributors and are intended to guide trial investigators, reviewers, and stakeholders in ensuring the integrity and transparency of clinical trials.