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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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Yes - There is 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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All data may be shared after de-identification of the participants
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When the data will become available and for how long
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شروع دوره دسترسی 6 ماه پس از چاپ نتایج
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To whom data/document is available
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The study data and documentation will be made available to individuals at academic and scientific institutions, as well as to employees of pharmaceutical companies.
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Under which criteria data/document could be used
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Access to the study data and documentation will be permitted after removal of identifying information and de-identification of the participants, solely for scientific and educational research purposes. The data must be used within the scope of scientific and research objectives, and any commercial use, re-identification of participants, or disclosure of identifiable information will be prohibited.
Requests for access must include the research purpose, type of data required, proposed analytical methods, and the intended use and data storage procedures. Requests will be reviewed and approved by the principal investigator and/or the relevant university authorities in accordance with applicable regulations. Statistical and research analyses related to scientific objectives will be permitted, provided that confidentiality is maintained and the participants cannot be identified.
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From where data/document is obtainable
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Applicants seeking access to the study data or documentation may submit a written request via email to the principal investigator. The request should include the applicant’s name and contact information, institutional affiliation, purpose of the request, type of data or documentation required, and intended use of the requested materials.
Requests will be reviewed and responded to by the principal investigator and, if necessary, by the relevant university authorities, in accordance with applicable regulations.
Contact information:
Principal Investigator: Dr. Mohaddeseh Shokrallahi
Email: M100124sh@gmail.com
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What processes are involved for a request to access data/document
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Applicants should submit their requests via email to the principal investigator. Each request will be reviewed with regard to the research purpose, type of data requested, and intended use of the data. Upon approval of the request and confirmation that the eligibility requirements have been met, the requested data and documentation will be provided in a de-identified and non-identifiable format.
The review and preparation of the requested data will generally be completed within a maximum of 30 business days from receipt of a complete request. If review by the relevant university authorities is required, the response time may depend on the duration of the review process by the respective authorities
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Comments
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