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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Due to ethical considerations, concerns about participant confidentiality, and the lack of an established secure data-sharing infrastructure, there is currently no plan to share individual participant data.
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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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No - There is not 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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Yes - There is a plan to make this available
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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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No - There is not a plan to make this available
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Title and more details about the data/document
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Full Study Protocol
Final Clinical Study Report
These documents will be provided as supplementary files to the main article or through appropriate repositories, depending on the journal's policy.
It should be noted that no raw data or individual-level participant information will be shared separately. All data will be presented only in an anonymized, aggregated, and analyzed form within the published report and article, in order to maintain participant confidentiality and data protection.
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When the data will become available and for how long
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Access to the study protocol and the final clinical study report will begin 6 months after publication of the final study results in a peer-reviewed journal. These documents will be made available as supplementary files or through public repositories associated with the journal. Once shared, access will remain open and unrestricted.
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To whom data/document is available
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The shared documents, including the study protocol and final clinical report, will be publicly available as part of the article supplement or through scientific repositories and will not require a formal request.
If additional data access is requested in the future, only researchers affiliated with academic institutions, licensed research centers, or recognized healthcare organizations will be eligible to apply.
Requests from industry professionals may also be considered if accompanied by a clear research objective and appropriate ethics approval.
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Under which criteria data/document could be used
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To access de-identified individual-level data or other study-related documents, the following conditions must be met:
*Conditions for Use of Data and Documents:
1-Data and documents may only be used for clearly defined, scientifically valid research purposes.
2-All analyses must be conducted within the scope of the approved research proposal.
3-Commercial, promotional, or political use of the data or documents is strictly prohibited.
4-Any publication resulting from the shared data must include proper citation of the original study and prior notification to the original research team.
5-The recipient must agree not to share the data with third parties and to use the data strictly within the approved scope.
*Requirements for Submitting an Access Request:
1-A formal written request including full applicant information and institutional affiliation.
2-A clear and specific research proposal outlining objectives, methodology, and the type of data required.
3-An official ethics committee approval (IRB approval) for secondary use of the data.
4-A signed Data Use Agreement committing to confidentiality, non-redistribution, and appropriate use of the data.
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From where data/document is obtainable
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In case of a formal request for access to anonymized individual-level data or study documents, the following conditions must be met:
Submission of a formal written request including the applicant's full details and institutional affiliation (preferably academic, clinical, or research-based).
Provision of a clear research proposal outlining the intended use of the data/documents.
Ethics committee approval for the proposed secondary analysis.
Signing of a Data Use Agreement (DUA) that includes commitments to:
not attempt re-identification of individuals,
not share data with third parties,
use the data solely for approved research purposes.
Permitted analyses must align with the objectives outlined in the request.
Commercial use, promotional purposes, or publication without prior approval are strictly prohibited.
All requests will be reviewed internally and, if approved, limited access will be granted under the defined terms.
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What processes are involved for a request to access data/document
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If access to study documents (e.g., study protocol or final report) or de-identified individual-level data is considered, the following process applies:
Submission of a formal written request, including applicant details, institutional affiliation, purpose of use, and specific documents or data requested.
Initial review by the research team within 2 weeks of receiving the request.
Upon preliminary approval, the applicant must:
Submit a relevant research proposal.
Provide IRB/Ethics Committee approval.
Sign a Data Use Agreement (DUA) outlining permitted uses and data protection commitments.
Following full review and signed agreement, approved documents or data will be provided within 4 weeks of the initial request.
Estimated total processing time: 4 to 6 weeks from complete request submission to data/document delivery.
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Comments
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