Item 31c: Plans, if any, for granting public access to the full protocol, participant-level dataset, and statistical code.
Example
“Data sharing statement No later than 3 years after the collection of the 1-year postrandomisation interviews, we will deliver a completely deidentified data set to an appropriate data archive for sharing purposes.”393
Explanation
Given the central role of protocols in enhancing transparency, reproducibility, and interpretation of trial results, there is a strong ethical and scientific imperative to ensure that full protocols are made publicly available.24;394;395 High-quality protocols contain relevant details on study design and conduct that are generally not available in journal publications or trial registries.84;396 It is also important to make available the full study report, such as the “clinical study report” submitted to regulatory agencies by industry sponsors.377;396-400 This detailed report provides the most comprehensive description of trial methods (including the full protocol) and all published and unpublished analyses. In addition, there have increasingly been calls to improve the availability of participant-level datasets and statistical code after journal publication to enable verification and replication of analyses, facilitate pooling with other studies, and accelerate research through open knowledge sharing.372;401-406
Avenues for providing access to full protocols include journals,407;408 trial websites, and trial registries.163 Several journals and funders support the sharing of participant-level data,405;409-411 while others routinely publish a statement regarding sharing of protocols, statistical codes, and datasets for all of their published research articles.412;413
The protocol should indicate whether the trial protocol, full study report, anonymised participant-level dataset, and statistical code for generating the results will be made publicly available; and if so, describe the timeframe and any other conditions for access.
| 31b: Authorship | 32: Informed consent materials |
