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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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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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Individual participant data, after anonymization (removal of identifying information), including baseline characteristics, administered interventions, and primary outcome measures, will be made available for sharing. In addition, if required, only data related to the primary outcomes and statistical analysis files will be provided to researchers. Access to the data will be granted after completion of the study and publication of the results, upon reasonable request to the principal investigator.
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When the data will become available and for how long
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Access to the study data and documentation will begin after the completion of the study and publication of the results. The data access period will start 6 months after publication of the article/results and will continue for a minimum of 2 years. During this period, anonymized data will be made available to researchers upon reasonable request.
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To whom data/document is available
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Study data will be made available to researchers and investigators active in academic and scientific fields. In addition, researchers affiliated with recognized research institutions or relevant organizations (including academic or sports institutions) may request access to the anonymized dataset by submitting a reasonable request with a clearly defined research purpose. The use of the data will be strictly limited to scientific and research purposes only.
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Under which criteria data/document could be used
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In addition to the eligibility criteria for applicants, access to the study data and documentation will be subject to the following conditions:
Submission of a formal request including a clearly defined research objective and a proposed analysis plan.
Use of the data strictly for scientific, academic, and non-commercial purposes.
Analyses must be conducted strictly within the scope of the approved objectives, and no analyses outside the approved scope are permitted.
No attempt to re-identify study participants at any stage of data use.
Maintenance of data confidentiality and prohibition of sharing data with third parties without prior written permission.
Use of the data only for statistical analyses and research purposes relevant to the study objectives (e.g., descriptive, inferential, or secondary analyses aligned with the study aim).
Adherence to ethical research principles and proper citation of the data source in any resulting publications.
Use of study documents (e.g., protocol, analysis files) strictly for scientific reproducibility and methodological review purposes of the data source in any resulting publications.
Use of study documents (e.g., protocol, analysis files) strictly for scientific reproducibility and methodological review purposes.
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From where data/document is obtainable
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Applicants seeking access to the study data and documentation should, in the first instance, contact the principal investigator of the study. Requests must be submitted in writing and include a description of the research purpose.
If necessary, communication may also be made via the official email of the principal investigator provided below:
Email: hanierasouli2001@gmail.com
Contact information:
Principal Investigator: Hanie Sadat Rasouli
Institutional Email: hanierasouli@sun.hsu.ac.ir
Phone number: +98 915 207 0440
Requests will be reviewed by the principal investigator, and will be accepted subject to approval and fulfillment of the required conditions.
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What processes are involved for a request to access data/document
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The review and provision of access to study data and documentation will follow a stepwise process:
Submission of request:
The applicant must submit a written request to the principal investigator. The request should include the research objective, intended analyses, and required data.
Initial screening:
The principal investigator reviews the request for completeness, scientific relevance, and compliance with ethical principles and data confidentiality requirements.
Evaluation and approval:
If necessary, the request is further assessed in terms of alignment with study objectives, feasibility of the proposed analyses, and data protection considerations. Additional information may be requested from the applicant.
Decision and agreement:
If the request is approved, a data use agreement may be established outlining access conditions, usage restrictions, and confidentiality obligations.
Data preparation and delivery:
Anonymized datasets and/or relevant study documents are prepared and securely transferred to the approved applicant.
Estimated timeline:
The entire process, from submission of the request to data access, typically takes approximately 2 to 4 weeks. This duration may vary depending on the complexity of the request and the need for clarification or additional information.
Final access will only be granted after approval by the principal investigator and completion of all required requirements
Anonymized datasets and/or relevant study documents are prepared and securely transferred to the approved applicant.
Estimated timeline:
The entire process, from submission of the request to data delivery, typically takes approximately 2 to 4 weeks. This timeframe may vary depending on the complexity of the request and the need for clarification or additional information.
Final access will only be granted after approval by the principal investigator and completion of any required agreements.
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Comments
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