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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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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 from this study will be shared after the trial's completion in a de-identified manner, without any identifiable information. Access to raw data related to the primary outcome variables, including loneliness scores, alexithymia, emotional security, and psychological well-being, will be made available upon request to qualified researchers. Under no circumstances will participants' identifiable information be accessible to individuals outside the research team at any stage.
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When the data will become available and for how long
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The access period begins 6 months and 2 yeras after the results are published
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To whom data/document is available
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De-identified individual participant data will be made available to qualified researchers. Requests will be accepted only from investigators affiliated with recognized academic institutions, research centers, or scientific organizations with a clear and relevant research purpose. Requests will be reviewed and approved by the study investigators.
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Under which criteria data/document could be used
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De-identified individual participant data will be used solely for scientific and non-commercial research purposes. Data use is limited to statistical analyses consistent with or complementary to the objectives of the original study. Commercial use, marketing purposes, or any non-scientific applications are strictly prohibited. Data recipients must maintain confidentiality, avoid any attempt to re-identify participants, and are not permitted to share the data with third parties without written permission from the study investigators. Access will be granted only after approval by the principal investigators and in accordance with ethical research principles.
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From where data/document is obtainable
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Qualified applicants seeking access to the de-identified data from this study may submit their requests to the principal investigator, Reyhaneh Sadat Sherafat, or to the supervising professor, Dr. Zahra Zanjanizadeh (Zanjani). Requests will be reviewed on a priority basis via email. If necessary, further correspondence will be conducted through the university where the study was conducted.
· Reyhaneh Sadat Sherafat (Principal Investigator): reyhanesadatsherafat1381@gmail.com
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What processes are involved for a request to access data/document
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Upon receipt of a request for access to de-identified individual participant data, the request will be reviewed by the principal investigator and the research team. The first step involves assessing the scientific merit and eligibility of the applicant. If preliminarily approved, the requester will be required to sign a data use agreement, including confidentiality and non-reidentification commitments. After completion of the required documentation, the requested data will be prepared and shared electronically with the applicant. Additional clarifications, if needed, will be handled via email correspondence. The entire process typically takes between 2 to 4 weeks.
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Comments
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