Clinical Trials: Registration & Data Sharing
For manuscripts reporting clinical trials, trial registration is required. Registration details must be provided in the manuscript and must identify the registry and registration identifier. Clinical trial reports must also include a data sharing statement that explicitly states: whether individual de-identified participant data (including data dictionaries) will be shared; what data will be shared; whether related documents (for example, protocol or statistical analysis plan) will be available; when the data will become available and for how long; and the access criteria, including with whom data will be shared, for what analyses, and by what mechanism.
Data & Reproducibility
Data Availability Statement (DAS)
On first use, a Data Availability Statement (DAS) is a short, explicit declaration stating whether the underlying data are available, where they can be accessed, and what conditions govern access. The DAS must be consistent with ethics and privacy obligations.
Data repositories and access modes
Where feasible, authors are encouraged to deposit data in reputable repositories that provide stable identifiers and access controls. Where open sharing is not possible, authors must specify controlled-access mechanisms and the rationale for restriction.
Code and analytic reproducibility
When analyses rely on code, authors should provide scripts or analytic workflows sufficient to permit reproduction of key results, subject to licensing, confidentiality, and security constraints. On first use, reproducibility means that an independent analyst can follow declared steps to reach materially consistent results, given access to the same data and tools.
Materials availability
If research uses instruments, stimuli, interview protocols, or specialised materials, authors should declare their availability and any restrictions.
Exceptions and justified limitations
The journal recognises that ethical and legal constraints may prevent open sharing of sensitive human data. In such cases, authors must provide a principled explanation and, where possible, a pathway for verification under protected conditions.