Order ID:89JHGSJE83839 | Style:APA/MLA/Harvard/Chicago | Pages:5-10 |
Instructions:
CMIS 4302 Patient Records Practice and Policy Paper
For this Application, assume that you have been asked to be a business consultant to a new medical practice (LA Healthcare Associates, LLC) containing one physician, one nurse and two office staff. They are going to use an India-based billing company and a Philippines-based transcription company. LA Healthcare Associates are not sure about the kinds of documents they need to deploy internally or with their vendors. They are also looking for guidance concerning HIPAA.
Gather together five business-related documents for this practice. Populate them with the company name, create a business address, and create fictitious profiles for the four employees of the practice (referenced above), and for the offshore entities.
Clinical Research FDA Audit Worksheet
You are the manager of a clinical research site, and you were just informed that your site has been selected for a routine FDA audit in a week.
Please outline the steps your site should perform to ensure you are inspection ready. If the sponsor personnel are relevant feel free to include but ensure you specify their roles and responsibilities.
Please include the roles and responsibilities of each staff member involved in the preparation. Please ensure you include the departments that you should inform, e.g. IRB. FYI, there may be other departments too.
Must be in a checklist format: responsible persons and task/activities and must include at least 15 tasks and include the contents of the regulatory binder. Please be thorough and ensure you cover all steps and departments. Do not include a narrative on the importance and purpose of audits as this is not part of the assignment. You will only be graded on a checklist. In addition, make it your own, be creative, and do not copy one from the internet. Instructor will be scrutinizing the Turnitin scores
Must include:
Checklist Format: use EXCEL with All of the following Columns: Task, Responsible Party, Completion Date, Finding and Comments
Roles and Responsibilities
Organization and relevance of the activities:
RUBRIC |
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Excellent Quality 95-100%
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Introduction
45-41 points The background and significance of the problem and a clear statement of the research purpose is provided. The search history is mentioned. |
Literature Support 91-84 points The background and significance of the problem and a clear statement of the research purpose is provided. The search history is mentioned. |
Methodology 58-53 points Content is well-organized with headings for each slide and bulleted lists to group related material as needed. Use of font, color, graphics, effects, etc. to enhance readability and presentation content is excellent. Length requirements of 10 slides/pages or less is met. |
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Average Score 50-85% |
40-38 points More depth/detail for the background and significance is needed, or the research detail is not clear. No search history information is provided. |
83-76 points Review of relevant theoretical literature is evident, but there is little integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are included. Summary of information presented is included. Conclusion may not contain a biblical integration. |
52-49 points Content is somewhat organized, but no structure is apparent. The use of font, color, graphics, effects, etc. is occasionally detracting to the presentation content. Length requirements may not be met. |
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Poor Quality 0-45% |
37-1 points The background and/or significance are missing. No search history information is provided. |
75-1 points Review of relevant theoretical literature is evident, but there is no integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are not included in the summary of information presented. Conclusion does not contain a biblical integration. |
48-1 points There is no clear or logical organizational structure. No logical sequence is apparent. The use of font, color, graphics, effects etc. is often detracting to the presentation content. Length requirements may not be met |
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CMIS 4302 Patient Records Practice and Policy Paper |
CMIS 4302 Patient Records Practice and Policy Paper