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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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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not 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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No - There is not a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Title: Dataset and Documentation for the Clinical Trial on Exosome Therapy vs. Mesotherapy for Hair Loss
Details: The dataset includes de-identified individual participant data related to the primary outcome (blinded Investigator Global Aesthetic Improvement Scale, blinded-IGAIS) and secondary outcomes (Patient Global Aesthetic Improvement Scales, PGAIS; patient satisfaction; reported side-effects). Additional documentation includes the study protocol, statistical analysis plan, and case report forms. Only de-identified data will be shared to protect participant privacy. Aggregate data, such as summary statistics and results published in the final report, may also be shared.
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When the data will become available and for how long
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Data and documentation will be available starting 6 months after the publication of the primary study results and will remain accessible for a period of 5 years.
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To whom data/document is available
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Access to the data and documentation will be restricted to academic researchers affiliated with recognized universities or research institutions. Requests from industry researchers may be considered on a case-by-case basis, provided they demonstrate a clear scientific purpose aligned with the study’s objectives.
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Under which criteria data/document could be used
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The data and documentation may be used for non-commercial research purposes, such as secondary analyses, meta-analyses, or validation studies, provided they align with the original study’s objectives. Users must agree to: Not attempt to re-identify participants.
Use the data solely for the approved research purpose.
Cite the original study and acknowledge Mazandaran University of Medical Sciences in any publications or presentations.
Submit a formal request detailing the intended use, including the proposed analysis plan.
Sign a data use agreement ensuring compliance with ethical standards and data protection regulations.
Requests will be reviewed by the study’s principal investigator and the Mazandaran University of Medical Sciences Research Ethics Committee.
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From where data/document is obtainable
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Requests for data or documentation should be directed to the principal investigator, Dr. Ghasem Rahmatpour Rokni, via email at dr.rokni@yahoo.com
Vice-Chancellor for Research and Technology
Mazandaran University of Medical Sciences
Moallem Square, Sari, Mazandaran, Iran
Phone: 09125443956
Requests can also be submitted through the university’s research portal: [insert website, if applicable]. The principal investigator or a designated member of the research team will respond to inquiries.
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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 via email or the university’s research portal, including a detailed proposal outlining the intended use of the data/documents, the research objectives, and the proposed analysis plan.
The request will be reviewed by the principal investigator and the Mazandaran University of Medical Sciences Research Ethics Committee within 4 weeks.
If approved, the applicant will be required to sign a data use agreement.
De-identified data and/or documentation will be provided in a secure format (e.g., encrypted files) within 2 weeks of agreement signing.
The entire process, from request submission to data delivery, is expected to take approximately 6–8 weeks, barring unforeseen delays.
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Comments
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