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CLINICAL STUDY REPORT and in the treatment of locally advanced or metastatic transitional cell carcinoma of the urinary tract in patients with impaired renal function and patients who have progressed.
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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.
ClinicalTrials.gov is a registry and results database of privately and publicly funded clinical studies conducted around the world. The resource is provided by the U.S. National Library of Medicine. Each study record includes a summary of the study protocol.
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?
A CSR must include an explanation of critical design features of the study, methods and how the study was carried out, individual patient data, and details of analytical methods.
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.
The CSR comprises: A synopsis that provides a summary of the content in the CSR. A methodology section, which introduces the study compound and the methods for conducting the study. The results and conclusions sections, which present the data from the study and a summary of conclusions about the data.
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.
This International Conference on Harmonization (ICH) document makes recommendations on information that should be included in a core clinical study report of an individual study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects.
Medical report template word Related content
CSOC Final Study Report Template
Purpose: MS Word template to be used as a starting point for preparing the final CSOC...
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