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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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Not applicable
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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 electronic prescribing data from the Iran Health Insurance Organization and coded qualitative interview files will be available after study completion.
The final study protocol, including objectives, methods, intervention, outcomes, and statistical analysis, will be available for dissemination after finalization.
The statistical analysis plan, including outcomes, variables, statistical models, and primary and secondary analyses, will be available after finalization.
The final clinical study report, including methods, main results, interpretation of findings, and study conclusions, will be available after study completion.
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When the data will become available and for how long
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Data will be available after study completion and publication of results, for a limited period, subject to approval by the research team and the relevant organization.
The protocol will be made available after final study registration and required approvals.
The statistical analysis plan will be available after protocol finalization and before the final data analysis.
The clinical study report will be available after completion of the study and finalization of the results.
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To whom data/document is available
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Qualified researchers for scientific purposes may access the data upon formal request and approval by the research team and the Iran Health Insurance Organization.
Researchers, reviewers, and individuals with scientific or academic purposes may access the protocol upon approval by the principal investigator.
Researchers, reviewers, and individuals with scientific purposes may access the statistical analysis plan upon approval by the principal investigator.
Researchers, reviewers, and individuals with scientific or academic purposes may access the clinical study report upon approval by the principal investigator.
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Under which criteria data/document could be used
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The data may be used only for scientific and research purposes, in de-identified form, after approval of the request and compliance with confidentiality requirements.
The protocol may be used only for scientific, research, and academic dissemination purposes with proper citation of the source.
This document may be used only for scientific, research, and methodological review purposes with proper citation of the source.
The clinical study report may be used only for scientific, research, and educational purposes with proper citation of the source.
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From where data/document is obtainable
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Applicants should submit their request to the principal investigator and, if required, to the Tehran Provincial Office of the Iran Health Insurance Organization.
Applicants should contact the principal investigator to request access.
Applicants should contact the principal investigator to request access.
Applicants should contact the principal investigator to request access.
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What processes are involved for a request to access data/document
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After formal submission, the request will be reviewed for scientific purpose, confidentiality compliance, and approval by the principal investigator and the relevant organization; if approved, limited access will be granted.
After submission, the request will be reviewed by the principal investigator, and if approved, the protocol will be provided.
After review by the principal investigator, and if approved, the statistical analysis plan will be provided.
After review by the principal investigator, and if approved, the clinical study report will be provided.
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Comments
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