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Protocol and statistical analysis plan

​Item 5: Where the trial protocol and statistical analysis plan can be accessed.

Example

 

“The full protocol, dataset, and statistical code are available in the Open Science [Framework] repository, DOI https://doi.org/10.17605/OSF.IO/6BA3W" [68]

 

"A detailed justification and explanation of these stages is included in the statistical analysis plan (SAP; see online supplemental file 2)” [69].

 

Explanation

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The protocol describes the study design and methods, including the main features of the statistical analysis (Item 27) and sample size calculation (Item 19). The statistical analysis plan (“SAP”) is an associated document that provides full technical details of the planned analyses for benefits and harms and their execution [70, 71]. Comprehensive guidance is available on the content of statistical analysis plans [71]. Typically, the statistical analysis plan is a separate document that should be read in conjunction with the protocol, but for some trials with simple analyses, the statistical analysis plan can be included as part of the protocol [72].

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Changes to the protocol and statistical analysis plan may happen after the trial begins, often for legitimate reasons (e.g., in response to new evidence or unanticipated challenges) [73]

These amendments should be transparently documented in each new document version (Item 31).

 

Given the central role of protocols and statistical analysis plans in enhancing the transparency, reproducibility, and interpretation of trial results, there is a strong ethical and scientific rationale for these key documents to be publicly available [74-78]. High-quality protocols and statistical analysis plans contain relevant information on study design and conduct that is often not reported in journal publications or trial registries [79, 80]. Having access to these documents may help with trial appraisal, interpretation, and replication, as well as identification of selective outcome reporting [81, 82].

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The protocol should indicate whether and how it will be made publicly available, along with the statistical analysis plan (if separate). Avenues for providing access to protocols and statistical analysis plans include stand-alone publication in journals, such as Trials and BMJ Open [3, 4] or posting the documents as an online appendix to the publication of trial results.

 

Most trial registries allow the full protocol and statistical analysis plan to be included along with the trial’s registration record. Other options include online repositories and preprint servers. Many journals routinely publish a statement regarding sharing of protocols, statistical codes, and datasets for all of their published research articles [83]

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Summary of key elements to address

  • Where the protocol will be accessible (e.g., publication, repository such as Open Science Framework, trial registry)

  • Where the full statistical analysis plan will be accessible​

Administrative information

Open Science

Introduction

Methods: Patient and public involvement, trial design

Methods: Participants, interventions, and outcomes

Methods: Assignment of interventions

Methods: Data collection, management, and analysis

Methods: Monitoring

Ethics

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