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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. What to do: Review the instructions for this week’s discussion posting. Preparation Review the materials for this module before attempting to generate your submission and responses in this Discussion Assignment How do I reply to a Discussion as a student? to an external site. Instructions Develop a detailed Level III discu‌‍‍‍‌‍‍‌‌‍‍‍‌‍‍‍‍‌‍‍ssion posting about clinical research data management (5 paragraphs + references). Respond to 2 fellow students with a Level III response. (See Levels of Conversation Handout for descriptions of amount and type of detail per level). Utilize the module readings; slide lectures, audiovisual materials and your own internet research to formulate a 5-paragraph discussion posting on data management in clinical trials with the following elements: 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 (remember the elements of SOPs from Module 3). Include references and URL‌‍‍‍‌‍‍‌‌‍‍‍‌‍‍‍‍‌‍‍s


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