I Would prefer that you answer the questions by hand as a hand written response is not only easier but it looks more as though that i have done it. All questions and assignment details are in attachment. I have also included lectures and the study module for your convenience.
Write an essay (with introduction and conclusion) on the suggested topic. Choose the aspect to speak about yourself.
Your introduction should include the thesis statement – main idea of the paper (here is more detailed explanation – https://essayshark.com/blog/how-to-write-a-thesis-statement-to-make-it-clear/). Don’t include any new information in the conclusion. It should restate the thesis statement of the paper.
Support your ideas with relevant arguments and examples (in-text citations). List 2-3 sources in the references. Make sure you stick to a required formatting style. Get benefits of these sources citationmachine.net and easybib.com.
MLA format – https://owl.english.purdue.edu/owl/resource/747/01/ https://owl.purdue.edu/owl/research_and_citation/mla_style/mla_formatting_and_style_guide/mla_in_text_citations_the_basics.html
Clinical research data management is in an evolutionary period because of the improvements in electronic health records, other forms of electronic data capture and harmonization of data collection standards (e.g., CDISC).
Data integrity is a primary requirement in FDA review and approval of a new medical product. The aim is to ensure generalizability of reliable and valid safety and efficacy data.
Develop a detailed Level III discussion posting about clinical research data management (5 paragraphs + references)
Identify and discuss three important issues in data management and how these issues impact the activities of clinical research site personnel and sponsor data monitors.
Search the internet and report on an example of a Data Management SOP. Is this an SOP for a sponsor or a site? Attach and critique the SOP .(STANDARD OPERATING PROCEDURE)
Search the internet and report on an example of a drug that was not approved by the FDA and discuss the key pertinent issues that led to FDA rejection of the NDA application.
Include references and URLs
Criteria Points
Description of three important issues in data management and how these issues impacted site personnel and sponsor data monitors
Description of a data management SOP found on the internet. How does the SOP follow standards for SOP development? (Include URL for the SOP)
Cited example of a drug that failed to achieve FDA approval and a discussion of related factors that prohibited approval
Clarity of presentation, references
Solutions need to be clear and preferably typed out. (unless your handwriting is neat and I can understand and read your writing easily.)
Proving need to be done in a step by step fashion with clear headings of what you are trying to prove. Workings need to be very detailed and explicit.
I need THREE examples for qn 1 part(c) instead of an example as stated in the question.
I would like to receive an update of the first part of your solution by Monday 5pm.
I would like the expert to complete the questions in the following order: Q3, 5, 4, 2 and 1.
Please only bid for this assignment if you are able to solve all the questions. If expert show from the initial update of solutions that he is proficient, deadline can be re-negotiated. Thank you.
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