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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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Not applicable
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Title and more details about the data/document
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De-identified individual participant data and related study documents. After publication of the main study results, de-identified participant-level data on demographic and clinical characteristics, group allocation, executive function outcomes, and adverse events, together with the study protocol and data collection forms, may be shared with qualified researchers upon reasonable request and after approval by the principal investigator and compliance with the relevant ethics requirements. No direct identifiers or information that could reasonably permit identification of participants will be shared.
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When the data will become available and for how long
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Access to the research data and related documents will begin six months after the publication of the main study results and will remain available indefinitely.
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To whom data/document is available
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Qualified researchers affiliated with recognized universities, scientific and research institutions, or healthcare centers may submit a request to access the study data or related documents. Access will be granted upon submission of a written request, a valid research proposal, ethics committee approval, and a signed data confidentiality agreement. Researchers employed in industry may apply only if they are formally collaborating with a recognized academic or research institution and meet the aforementioned requirements.
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Under which criteria data/document could be used
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The research data and related documents may only be used for scientific and research purposes, including statistical analyses, secondary data analyses, and validation of the study findings. The provided data will be shared in a de-identified format, and any commercial use, transfer of data to third parties, or attempts to re-identify participants will be prohibited. Data access will be subject to submission of a formal request, a description of the intended purpose and analysis methods, verification of the applicant’s scientific qualifications, ethical approval when required, and agreement to maintain confidentiality and ensure responsible use of the data.
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From where data/document is obtainable
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Applicants seeking access to the research data or related documents should first submit a formal request by email to Ms. Yasaman Sadat Tabatabaei, the principal researcher, at y.tabatabaei@mail.sbu.ac.ir. The request should include the applicant’s full details, academic or institutional affiliation, the intended purpose of data use, a brief description of the proposed research, and the planned analytical methods.
When necessary, requests will be reviewed in coordination with the study supervisors, Dr. Vahid Sadeghi Firoozabadi and Dr. Vahid Nejati, and the study advisor, Dr. Ehsan Aghaei Moghadam. Institutional inquiries concerning clinical data or study documents may also be directed to the Heart Research Center affiliated with Tehran University of Medical Sciences. Data or documents will be provided only after approval of the request, compliance with ethical requirements, and completion of a confidentiality agreement.
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What processes are involved for a request to access data/document
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Applicants must submit a formal request by email to the principal researcher. The request should include the applicant’s identity and institutional affiliation, the intended purpose of using the data or documents, a brief description of the proposed research, the planned analytical methods, and ethics committee approval when required.
Receipt of the request will be acknowledged within a maximum of five working days. The request will then be reviewed for scientific merit, ethical compliance, feasibility, and consistency with the participants’ informed consent. This review will be conducted by the principal researcher and, when necessary, in coordination with the study supervisors and the relevant research center. The review process will normally take between 10 and 15 working days.
Following preliminary approval, the applicant will be required to sign a confidentiality and responsible data-use agreement and provide any additional documents, if necessary. Once all requirements have been fulfilled, the approved de-identified data or study documents will be securely provided within a maximum of 10 working days.
Overall, when the request and supporting documents are complete, the process is expected to take approximately three to six weeks. Incomplete requests or applications requiring additional ethical or institutional review may take longer
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Comments
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