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Page 1 of 2COGACCL20N1CD: Financial Distress during Treatment for Pediatric Acute Lymphoblastic Leukemia in the United States FAST FACTS Eligibility Reviewed and Verified By ___ MD/DO/RN/LPN/CRA Date
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The rationale and design of refers to the underlying reasoning and structured blueprint that explains the objectives, strategies, and methods for a particular project or study.
Individuals or organizations conducting research, clinical trials, or projects that require regulatory oversight are typically required to file the rationale and design.
To fill out the rationale and design, one should clearly delineate the purpose, methodology, target population, and any expected outcomes, while adhering to any specific guidelines set by the relevant authority.
The purpose of rationale and design is to provide a clear framework that justifies the project's need, outlines its execution, and ensures compliance with regulatory standards.
Information that must be reported includes the project's objectives, methodology, participant criteria, data collection plans, and expected impacts or outcomes.
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