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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not 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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The complete study protocol (research proposal) including objectives, methodology, inclusion/exclusion criteria, interventions, outcome measures, and statistical methods also The final clinical study report including the main results and findings of the research, which will be published as scientific article(s) in peer-reviewed journals, as well as the final project report submitted to the university.
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When the data will become available and for how long
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For Study Protocol: From the time of final registration of the trial with the Iranian Registry of Clinical Trials (IRCT), throughout the study duration, and permanently after study completion.
For Clinical Study Report: After publication of the article in scientific journals and submission of the final report to the university.
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To whom data/document is available
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For Study Protocol: Researchers, students, and other individuals interested in the study topic.
For Clinical Study Report: The scientific community, researchers, students and the general public.
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Under which criteria data/document could be used
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For Study Protocol: For research, educational purposes, and to understand the methodological details of the study. Use of content is permitted with appropriate citation.
For Clinical Study Report: For scientific, research, educational, and informational purposes. Use of results for systematic reviews and meta-analyses is permitted with appropriate citation.
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From where data/document is obtainable
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For Study Protocol: Through the Iranian Registry of Clinical Trials (IRCT) website (after final registration) or by contacting the principal investigator (Dr. Navid Taheri, email: n_taheri@rehab.mui.ac.ir).
For Clinical Study Report:Through scientific journal databases (after publication) or by contacting the principal investigator.
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What processes are involved for a request to access data/document
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For Study Protocol (if requested directly): Requests will be sent via email to the principal investigator. After review, the protocol will be provided to the requester.
For Clinical Study Report (if requested directly before public release): Requests will be sent via email to the principal investigator. Once the report/article is prepared and before public release, the request can be considered.
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Comments
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