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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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The de-identified data for this study includes general demographic information and results from research instruments (such as questionnaires, checklists, or clinical measurements). These data are stored in SPSS or Excel software files. Access to data after publication of the original results will be possible only for non-commercial research purposes and upon submitting a written request along with a brief research plan to the principal investigator. Any use requires acknowledgement of the original source. All shareable data is completely anonymized. All direct identifying information (such as name, contact number, national code, address) has been removed from the original dataset and replaced with a random numeric code. The file linking these codes to the real identities of individuals will be kept separately and confidentially by the main researcher and will not be made available to others under any circumstances.
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When the data will become available and for how long
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The data from this study will be available for legitimate research requests 6 months after the acceptance and electronic publication of the first original article in a reputable journal.
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To whom data/document is available
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Access to this research dataset will be granted only to applicants who meet the following criteria:
1. Researchers and graduate students affiliated with an accredited academic or research institution.
2. The purpose of the request is to conduct non-commercial scientific research (such as a thesis, review article, meta-analysis, or research project).
3. A written request (official email) along with a brief research plan (Proposal) that clearly explains the goals, methods, and necessity of using these data has been submitted to the principal investigator.
4. Commit to using the data only for the purpose specified in the application and to refrain from any attempt to re-identify participants.
5. Commit to fully and appropriately citing the original source of the data (this thesis/article) in any publication resulting from these data.
6. Written consent from the principal investigator and, if necessary, re-approval from the ethics committee issuing the project has been received.
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Under which criteria data/document could be used
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The data from this study may be used for scientific, research, and non-commercial purposes only. Permitted uses include:
· Conducting secondary analyses to answer new research questions.
· Conducting meta-analyses or systematic reviews.
. Replication or validation of the findings of the original study.
· Use as teaching data or samples in research methods courses (with confidentiality).
Basic Terms and Conditions of Use:
1. Ethical commitment: The user undertakes to never use the data to identify or contact participants and to respect their privacy.
2. Use restrictions: The data must not be used for commercial, marketing, insurance, legal or any discriminatory purposes.
3. Indexing and Citation: Any publication (article, report, thesis) that uses these data is required to properly cite and mention the original source (including the trial registration number in IRCT and the original article/thesis).
4. Prohibition of transfer: The user does not have the right to transfer the data to a third party or upload them to another public repository, except with the written permission of the principal investigator.
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From where data/document is obtainable
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Applicants for data access should send their formal request in the form of an email to the address of the author of this proposal.
· Name and surname: Shabnam Rashidi
· (Email): EstShaNur@gmail.com
Required documents to accompany the email application:
1. A brief research proposal containing the title, objectives, methodology, and justification for the need for the data of this study.
2. A brief CV of the applicant.
3. A written commitment to comply with the conditions mentioned in this proposal (non-commercial purposes and confidentiality).
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What processes are involved for a request to access data/document
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The data access request will be processed through the following steps:
1. Submitting the initial request: The applicant sends a formal email containing the following to the designated contact point:
· Self-introduction and institutional affiliation
· Description of the research objective and scientific justification for the need for the data
· Brief research proposal
· Scientific CV
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Comments
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