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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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Yes - There is 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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After completion of data analysis, de-identified individual participant data—including demographic information and outcomes related to the primary and secondary variables—will be available upon reasonable written request from qualified researchers, subject to approval by the principal investigator. All identifiable information will be removed or anonymized before sharing.
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When the data will become available and for how long
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Access to de-identified participant data will be available starting six months after publication of the study results and will remain accessible for five years thereafter.
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To whom data/document is available
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The data will be available to researchers and academic faculty members from universities or research institutions who have a relevant research proposal and obtain approval from an ethics committee.
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Under which criteria data/document could be used
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The data may only be used for scientific and educational research purposes. Data use must align with approved research objectives and have prior ethical committee approval. Applicants are required to submit a research proposal, a data use agreement, and a confidentiality commitment. Any commercial use, unauthorized publication, or analysis beyond the approved scope is strictly prohibited.
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From where data/document is obtainable
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Requests for access to the data or related documents should be addressed to Dr. Afshin Moghaddasi, Assistant Professor, Payame Noor University.
Postal Address: Payame Noor University, Nakhl Street, Artesh Boulevard, Tehran, Iran, Postal Code: 193954697
Phone: +982122450000
Email: moghadasi@pnu.ac.ir
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What processes are involved for a request to access data/document
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The process for requesting data or documents is as follows:
1.The applicant prepares a research proposal along with a data access request form and a confidentiality agreement, and submits them via email to Dr. Afshin Moghaddasi.
2. The request is reviewed by the University Ethics and Research Committee to ensure that the intended use of the data aligns with the study protocol and ethical guidelines.
3. Upon approval, access to the de-identified participant data or requested documents is granted, and the relevant files or download link are sent via email.
4. The entire process typically takes 2 to 4 weeks after receiving the complete request, depending on the data volume and review time.
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Comments
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All provided data and documents will be accessible after removing any personally identifiable information of participants. Any use of the data must comply with the approved research objectives, and publication of results should cite the original study. Applicants are also required to adhere to all data protection regulations and maintain confidentiality of the information.