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Bridging Subversion No. 5.0Version Date: 02/08/2016 Bridging Study Phase 2 Study Investigating, and for Children, Adolescents, and Young Adults (AYA) with Acute Leukemia and Minimal Residual Disease
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Bridging study version no is required by individuals or organizations involved in conducting or overseeing bridging studies.
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This may include researchers, regulatory authorities, pharmaceutical companies, clinical trial sponsors, or institutions conducting bridging studies to gather additional data or evidence on the efficacy and safety of a particular drug or medical intervention.
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The purpose of a bridging study is often to establish a correlation or comparison between the results obtained from different populations or geographical regions.
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It ensures that the drug or intervention is equally effective and safe in diverse populations, allowing for broader application or regulatory approval in multiple regions or countries.
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The bridging study version number refers to the specific version identifier assigned to a regulatory document that outlines a bridging study, which is conducted to provide evidence that a product is comparable in quality and efficacy to an existing product.
Researchers or organizations conducting bridging studies, as part of their regulatory submissions to health authorities, are required to file the bridging study version number.
To fill out the bridging study version number, document the version history in chronological order, starting with the initial submission and including all revisions, by specifying the version number in accordance with the regulatory authority's guidelines.
The purpose of the bridging study version number is to track the evolution of the study documentation, ensuring that all parties are aware of which version is current and to facilitate clear communication during regulatory review.
The information that must be reported includes the version number, date of the version, summary of changes made, and the authors or parties responsible for the document.
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