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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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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be 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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The shared dataset will include de-identified individual participant data after removal of all direct and indirect identifiers. Data eligible for sharing will comprise key demographic variables, primary and secondary outcome measures, and variables used in the main statistical analyses. Raw data containing identifiable information, complete medical records, or participant contact details will not be shared.
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When the data will become available and for how long
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Data will be available starting 6 months after publication of the primary study results and will remain accessible for a period of 5 years.
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To whom data/document is available
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Access may be granted to qualified researchers affiliated with academic institutions, research centers, or recognized scientific organizations. Requests from industry researchers may also be considered upon submission of a scientifically sound research proposal and approval by the relevant review committee.
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Under which criteria data/document could be used
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The data may be used solely for scientific research purposes, including secondary analyses. Applicants must submit a clear research proposal and sign a data use agreement committing to ethical use and non-attempt of participant re-identification. Commercial use, data redistribution, or any use beyond the approved scope is not permitted.
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From where data/document is obtainable
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Requests for data access should be submitted by contacting the corresponding investigator of the study via email.
If required, requests will be forwarded to the relevant scientific or ethics committee for review.
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What processes are involved for a request to access data/document
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Upon receipt of a request, the research proposal will be reviewed by the study team. If necessary, the request will be evaluated by the relevant scientific or ethics committee. Following final approval and signing of a data use agreement, the data will be shared through a secure method. This process typically takes 4 to 8 weeks.
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Comments
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