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SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

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Essay on Project Management and Assignment Cover Sheet

Grading for this assignment will be based on answer quality, logic / organization of the paper, and language and writing skills, using the following rubric.

Although analysis of large databases can offer many advantages with regards to sample size and cost, the quality of the data is not as robust as that derived from prospective clinical trials and treatment bias may be introduced as assignment to treatment is not randomized. Determination of the timing of specific outcomes such as diabetes onset may be imprecise and diabetes remission may need to be determined indirectly through prescription information. Validation of the data collected should be an important aspect of the application. Furthermore, potential changes in the International Classification of Diagnosis (ICD) codes may impact on longitudinal comparisons. These limitations and others need to be addressed in the application by sophisticated statistical methodologies and the appropriate expertise. The investigative team should include and reflect the methodological, statistical and clinical expertise required by the proposed study. Potential comparisons could entail those undergoing bariatric surgery to a non-surgical control group matched for clinical and demographic characteristics or comparisons between types of bariatric surgeries. Studies should propose outcomes occurring at minimum 5 years post-surgery.

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