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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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De-identified individual participant data will be available after completion of the trial. Upon reasonable request from qualified researchers, access may be granted to raw data related to the primary outcome variables, including substance craving scores, shame scores, self-control scores, and interpersonal sensitivity scores. Personal identifying information will not be shared at any stage of data access.
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When the data will become available and for how long
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Access to de-identified individual participant data will begin 6 months after publication of the study results and will remain available for a period of 2 years thereafter. During this period, data will be shared with qualified researchers upon reasonable request and approval by the research team.
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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. Access will not be granted to non-research individuals, commercial entities, or applicants outside the academic and scientific field.
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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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Requests for access to de-identified study data should be directed to the principal investigator or the study supervisor. Requests will be primarily handled via email. Additional correspondence may be conducted through the affiliated university if necessary.
Principal Investigator: Razieh Shokri
Supervisor: Dr.Zahra Zanjani
Email:shokri-r@kaums.ac.ir
Postal address: Faculty of Psychology and Educational Sciences, Kashan University, Iran
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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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