Clinical Trial Registration & Data Transparency
Eurasian Clinical and Analytical Medicine (ECAM) requires prospective registration of clinical trials in a publicly accessible registry and encourages clear Data Availability Statements and Individual Participant Data (IPD) sharing plans. These practices promote accountability, reproducibility, and responsible data stewardship.
Prospective Registration (Before First Participant)
Trials must be registered before enrolment of the first participant in a WHO-recognized public registry such as ClinicalTrials.gov, the WHO ICTRP Primary Registries (e.g., EU CTR/Clinical Trials Register, ISRCTN, ANZCTR, IRCT, UMIN-CTR, ChiCTR, CTRI). The registry name and identifier must appear in the manuscript (preferably in the Abstract and Methods).
- Provide protocol and (when applicable) statistical analysis plan (SAP) as supplementary files or links.
- Report any protocol amendments and update the registry accordingly (e.g., primary outcomes, sample size).
- Retrospective registration is strongly discouraged; if unavoidable, justify in the cover letter and Methods and label the trial as retrospectively registered.
Reporting Standards & Transparency
- Follow CONSORT guidelines for randomized trials, including a flow diagram and checklist.
- Post summary results in the registry when required by law or policy.
- Disclose funding sources and the role of funders; declare all conflicts of interest.
Data Availability & IPD Sharing
Manuscripts must include a Data Availability Statement and, when appropriate, an IPD sharing plan consistent with ICMJE recommendations. Data should be de‑identified to protect participant privacy and shared under licenses and governance that comply with applicable regulations (e.g., GDPR).
- Preferred repositories include trusted, persistent services (e.g., Dryad, Zenodo, Figshare, OSF, institutional repositories) with DOIs and versioning.
- Specify what data, documents (e.g., protocol, SAP, codebook), code, and materials will be shared; where they will be hosted; when they will become available; and under what access conditions.
- Where legal/ethical constraints apply, state the limitations and provide a controlled‑access mechanism (e.g., data use agreements, qualified researcher requests).
Example registration statement: This trial was prospectively registered at ClinicalTrials.gov (NCT01234567) prior to participant enrolment. The protocol and SAP are available in Supplementary Files.
Example data availability statement (open): De‑identified IPD, protocol, SAP, and code will be available on Dryad (DOI assigned upon acceptance) immediately after publication under CC BY 4.0.
Example data availability statement (controlled): De‑identified IPD will be available upon reasonable request to the corresponding author for 36 months post‑publication under a data use agreement; aggregated data and code are openly available at Zenodo (DOI).
Ethical Compliance & Privacy
Registration and data sharing must align with ethical approvals and informed consent. Patient confidentiality must be protected; only de‑identified data should be shared. If consent did not cover data sharing, explain how privacy is safeguarded or provide reasons for non‑sharing.
