Health Medical Homework Help

This assignment must be between 500– 650 words

Details  for this assignment: draft an essay describing what these FDA steps may mean at a site level. Please ensure you provide an example of each step, and a summary paragraph as to how all of the steps should culminate in a quality outcome. 

The FDA recommends a four-step systems approach to improving quality in clinical trials:

• Say what you do
• Do what you say
• Prove it
• Improve it

At some point in the conduct of a clinical research study, there may be a regulatory inspection.  The purpose for a regulatory inspection of a clinical trial is two-fold: to ensure that the data collected in the study is true and verifiable and to be certain that the human subjects were protected during the study. A good approach is to Begin with the End in Mind which ensures quality principles were followed during the clinical trial. For the assignment this module (Assignment 3) you are required to write an essay about quality issues in clinical research. To get you started thinking about this topic, please read the attached PDFs and complete the assignment