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BMS337039/OPC14597CN138002 Abbreviated Clinical Study ReportABBREVIATED CLINICAL STUDY REPORT CN138002 TITLE OF STUDY: A Multi center, Randomized, Double blind Safety and Tolerability Study of Flexible.
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EPS FAQ
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Abbreviated CSRs are condensed versions of the full CSR, and are generally used for studies not intended to support the efficacy claim for the dose, regimen, population, or indication. These types of CSRs usually contain abbreviated methods and efficacy, but almost always include comprehensive safety.
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5 Guidelines for Writing Clinical Trial Lay Summaries Use short sentences. The number one thing you can do to make your lay summary easier to read and translate is to shorten your sentences. ... Standardize terminology. ... Use consistent grammar and style. ... Avoid jargon and scientific/medical language.
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Clinical Study Reports (CSRs) are often created as part of the process of submitting applications for new medical treatments to regulators. CSRs answer questions such as: Why was the trial done? What were the important questions asked in the trial? What were the results?
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Abstract: the CONSORT-way. The trial report abstract is important because it will likely have many more reads than the full trial report. ... Introduction: the 'why' of your trial. ... Methods: the 'how' of your trial. ... Methods: outcomes. ... Methods: interventions. ... Methods: sample size. ... Methods: statistical analyses. ... Results: attrition.
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Topics included in a clinical trial protocol Title page (general information) ... Background information. ... Objectives/purpose. ... Study design. ... Selection and exclusion of subjects. ... Treatment of subjects. ... Assessment of efficacy. ... Assessment of safety.
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An abbreviated report should contain a full report of information related to safety and enough information to allow the reviewers to fully assess whether the efficacy results, if any, cast doubt on the effectiveness of the product for the proposed indication.
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While the FDA has given clear guidance on the construct of a CSR, there are four different types of CSRs that sponsors typically use in various situations. Type 1: Full CSRs. Type 2: Supplemental CSR. Type 3: Abbreviated CSR. Type 4: Synoptic (or Synopsis) CSR.
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A Clinical Study Report ( CSR ) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related to the study.
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