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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The shared data may include de-identified demographic variables, primary outcome data, and selected secondary outcomes. All shared datasets will be fully anonymized in accordance with confidentiality standards. Data will only be shared upon formal request and with approval by the ethics committee or relevant authorities. Public release of the full dataset is not planned at this stage, but specific outcome data may be included in future publications, following ethical guidelines.
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When the data will become available and for how long
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Access to aggregated, de-identified outcome data will begin approximately a few months after the publication of final results in a scientific article or thesis. Only summarized data will be publicly available through publications. No direct access to raw individual participant data is planned.
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To whom data/document is available
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Access to the study data and documents is limited to the principal investigator, research team members, academic supervisor, and, if necessary, the Ethics Committee of Shahid Beheshti University. Other individuals will only have access to aggregated and analyzed results published in the thesis or scientific articles. No direct access to raw data is planned for the public or external researchers.
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Under which criteria data/document could be used
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The data and documents from this study may only be used for research and educational purposes, in full compliance with ethical research principles, data confidentiality, and non-disclosure of participants' identities. Usage is limited to the results presented in the thesis or scientific publications. No access to raw data is permitted for third parties.
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From where data/document is obtainable
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Any requests for access to the data or documents related to this study must be formally submitted in writing to the principal investigator or the academic supervisor at the Faculty of Physical Education, Shahid Beheshti University. Approval from the university’s Research Ethics Committee may also be required, depending on the nature of the request.
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What processes are involved for a request to access data/document
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in the event of receiving a formal request for access to the study’s data or documents, the request will first be reviewed by the principal investigator or the academic supervisor.
If the nature of the request involves access to unpublished or ethically sensitive information, it will be referred to the Research Ethics Committee of Shahid Beheshti University for final approval.
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Comments
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