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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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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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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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Title: De-identified individual participant data, study protocol, statistical analysis plan, clinical study report, and data dictionary
Details: De-identified individual participant data (IPD), the study protocol, statistical analysis plan, clinical study report, and data dictionary will be available upon completion of the study and main publication. Access is granted to qualified researchers via a formal request and is subject to approval and commitment to confidentiality.
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When the data will become available and for how long
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Access to the documents and de-identified data will commence immediately following the final completion of the study and publication of the main results (primary manuscript). This access will be maintained for a period of at least 5 years from the publication date.
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To whom data/document is available
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The data will be accessible to all academic and non-academic researchers from scientific and medical institutions. Requests must be submitted by a formal Principal Investigator (PI). The main condition for access is the submission of a scientifically sound analysis plan, signing of a Data Use Agreement (DUA), and a commitment to maintaining participant confidentiality and using the data strictly for research purposes.
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Under which criteria data/document could be used
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Purpose of Use: The primary purpose of data sharing is to enable complementary scientific analyses, replication of primary findings, and re-analysis of the data by independent researchers.
Mandatory Conditions:
1. Valid Research Plan: The applicant must submit a scientifically sound research proposal or protocol detailing the intended use of the requested data.
2. Non-Commercial and Research Use: Use of the data and documents must be strictly for research and educational purposes. Any commercial or proprietary use is prohibited.
3. Agreement Signing: The applicant must sign a Data Use Agreement (DUA), committing to the complete confidentiality of participants and explicitly agreeing not to attempt re-identification.
4. Attribution (Citation): If any results are published, the researcher receiving the data must cite the original study (IRCT) and the primary publication.
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From where data/document is obtainable
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Applicants must submit a formal request containing a detailed scientific analysis plan, along with their full contact information, to the email address of Dr. Afshin Moghadasi (moghadasi@pnu.ac.ir). Following the review and approval of the proposal by the research team, and upon meeting the required criteria, a Data Use Agreement (DUA) will be issued for signature. Subsequently, the de-identified data will be shared with the applicant.
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What processes are involved for a request to access data/document
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The process for accessing the data and documentation of the “Effect of Gluteal Muscle Strengthening on Balance and Athletic Performance” study involves four main stages:
1. Formal Application: The applicant must submit a formal request including a detailed scientific analysis plan, full contact details, and a commitment to research-only use, to the email address of the primary contact (Dr. Afshin Moghadasi: moghadasi@pnu.ac.ir).
2. Proposal Review (Estimated Time: 1 to 3 working weeks): The applicant’s request will be reviewed by the study’s research team for scientific merit, alignment with the primary publication objective, and adherence to ethical standards.
3. DUA Execution (Estimated Time: 2 to 4 working weeks): If the proposal is approved, a Data Use Agreement (DUA) will be sent to the applicant. The applicant is required to sign this document and return it to the research team. This agreement mandates a commitment to maintaining confidentiality and not attempting to re-identify participants.
4. Data Provision (Estimated Time: 1 to 3 working days): Upon receipt of the fully executed DUA and finalization of administrative procedures, the de-identified data and approved documentation (protocol, analysis plan, etc.) will be provided to the applicant in electronic files.
Overall Time Estimation: The estimated time to complete the entire process, from receiving the initial request to the final provision of data, assuming the applicant provides complete documentation and the proposal is quickly approved, is approximately 3 to 7 working weeks.
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Comments
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