At some point in the conduct of a clinical research study, there may be a regula

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 course of the clinical trial. For the assignment you are required to write an essay about building quality into clinical research. To get you started thinking about this topic, please read the concise article, attached.
The FDA recommends a four-step systems approach to improving quality in clinical trials which aligns with the process: Plan, Do, Check & Act (PDCA):
• Say what you do
• Do what you say
• Prove it
• Improve it
Details for this assignment: publish 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.
Grading based on following criteria
10 Points: Introduction Paragraph (set the stage)
15 Points: Fully describes “Say What You Do”
15 Points: Fully describes: “Do What You Say”
15 Points: Fully describes: “Prove it”
15 Points: Fully describes: “Improve It”
15 Points: Conclusion Paragraph that describes how all of the steps should culminate in a quality outcome
15 Points: Overall good writing demonstrated
Essays are shorter pieces of writing – this assignment must be between 3-5 pages. I’d like to see good quality writing which means that you should revise and proofread as often as it takes in order to make the submission informative and succinct. References should not be included in the word count.
Use the assignment as an opportunity to apply what we have learned through readings, discussions and express your ideas about quality in clinical research.