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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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De-identified individual participant data, study protocol, statistical analysis plan, and data dictionary
The individual participant data of this study include baseline demographic information, primary and secondary outcome variables, and measurement results. All data will be shared after complete removal of personal identifiers and will be provided in a fully de-identified format. Complete raw datasets for all primary and secondary outcomes will be available for sharing. In addition, the final study protocol, the pre-specified statistical analysis plan, and the data dictionary will be shared to facilitate proper understanding and reuse of the data.
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When the data will become available and for how long
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Access to the data and related documents will begin 6 months after publication of the final study results and will remain available for 5 years following the publication date.
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To whom data/document is available
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The data and study documents will be made available to researchers affiliated with academic, research, and scientific institutions. Researchers outside academic settings may also be granted access upon submission of a scientifically valid request.
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Under which criteria data/document could be used
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The data will be available exclusively for scientific research purposes, including secondary analyses, systematic reviews, meta-analyses, and comparative studies. Commercial use of the data is not permitted. Applicants must submit a brief research proposal describing the study objectives, planned statistical analyses, and a commitment to maintaining data confidentiality. Any use of the data must appropriately acknowledge the original study.
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From where data/document is obtainable
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Requests for access to the data and study documents should be submitted through direct correspondence with the principal investigator.
Primary contact method: email communication with the principal investigator.
If no response is received, requests may be followed up through the registered postal address of the study.
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What processes are involved for a request to access data/document
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After submission, the applicant’s research proposal will be reviewed by the principal investigator for scientific and ethical appropriateness. Upon approval, the de-identified data will be provided within 4 weeks. In case of rejection, the reasons will be communicated to the applicant in writing.
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Comments
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All shared data will be fully de-identified, and data sharing will be conducted in accordance with research ethics principles and national data protection regulations.