FDA Guidelines on Safety Reporting Requirements for IND BA and BE Discussion
In the FDA’s guidance document “Safety Reporting Requirements for INDs and BA/BE Studies,” the FDA outlines the importance of identifying and characterizing adverse events that arise during the course of clinical trials. Importantly, the FDA outlines the types of events that MUST be reported to the FDA in the form of IND Safety Reports. Describe […]
reporting of infectious disease
Choose either a specific country’s guidelines or the WHO’s guidelines regarding the reporting of infectious disease. Apply these requirements to a specific outbreak situation. What role would health systems play in applying these regulations? Describe and assess health systems in the prevention and containment of the disease. Which do you think are most effective and […]
Adverse Event Reporting Read Chapters 5, 6, and 7 in our textbook. After reviewing this week’s required reading, consider the following scenario. You are the lead of the risk management team that has
Adverse Event Reporting Read Chapters 5, 6, and 7 in our textbook. After reviewing this week’s required reading, consider the following scenario. You are the lead of the risk management team that has been assigned to evaluate an incident that has occurred. You will prepare a report for the CEO of the hospital that includes […]
2 questions 250 words each 2 references: 1. Discuss the importance of the ethical delivery of care and regulatory reporting as it relates to the doctorally prepared advanced nurse’s practice. How mig
2 questions 250 words each 2 references: 1. Discuss the importance of the ethical delivery of care and regulatory reporting as it relates to the doctorally prepared advanced nurse’s practice. How might ethical principles informed by a Christian perspective be beneficial for Christians and non-Christians alike? 2. Drawing on your nursing or nursing leadership experience, […]
2 questions 250 words each. 2 references each 1. The “Revised Standards for Quality Improvement Reporting Excellence: SQUIRE 2.0” guidelines, located in the topic Resources, provide some guidance on t
2 questions 250 words each. 2 references each 1. The “Revised Standards for Quality Improvement Reporting Excellence: SQUIRE 2.0″ guidelines, located in the topic Resources, provide some guidance on the evaluation of quality improvement efforts. They are used as both grant proposal and manuscript publication preparation guidelines. Discuss how your project aligns with the SQUIRE […]
Health Information Technology Most healthcare focused departments utilize technology for data collection, storage, analysis, and reporting of information. For this assignment, select a healthcare orga
Health Information Technology Most healthcare focused departments utilize technology for data collection, storage, analysis, and reporting of information. For this assignment, select a healthcare organization or hospital department and Describe the organization or hospital department. Identify types of information collected, including format and approximate volume. Compare and contrast three data storage or databases used by […]
Assessment Description Review your state’s mandated reporter statute. Provide details about this in your post. If faced with a mandated reporter issue, what are the steps in reporting the issue? Creat
Assessment Description Review your state’s mandated reporter statute. Provide details about this in your post. If faced with a mandated reporter issue, what are the steps in reporting the issue? Create a mandated reporter scenario and post it. Respond to one of your peer’s scenarios using the guidelines for submission/reporting in your state. Be sure […]
As a public health analyst (currently reporting to an epidemiologist), you will focus on analyzing the relationship between epidemiology and public health. Your skill in public health is essential to
As a public health analyst (currently reporting to an epidemiologist), you will focus on analyzing the relationship between epidemiology and public health. Your skill in public health is essential to promoting health in your community, regardless of which health care sector your future career takes you to. The PERIE model is a tool you’ll use to analyze each component of […]
