I am needing responses to the following discussion posts. These posts need to be at least 300 words for each post with references in APA Format

I am needing responses to the following discussion posts. These posts need to be at least 300 words for each post with references in APA Format

I am needing responses to the following discussion posts. These posts need to be at least 300 words for each post with references in APA Format


I began my clinical research career as a Research Nurse Coordinator and I enjoyed the patient interaction and learning about the many different research protocols and how each had to be implemented. Curiosity called to me and I was motivated to learn more and more about the disease processes and why the clinical trial was being administered. I enjoyed interacting with the research monitors when they came to the site to verify research data, and from there I developed an interest in research quality and compliance. To me, clinical research provides the opportunity to help people on a large scale by offering potential new treatments while also ensuring that data is collected and documented per the protocol and regulatory requirements. I am a “full-circle” type of person thus quality appeals to me from many angles including educating staff, collaborating with the research site, medical operations, and the training department to identify preventative actions and mitigate risks.

My capstone project involves the development and implementation of an Inspection Readiness Assessment (IRA) tool for quality management of participant safety and research data at clinical research sites. I chose this topic because I identified a need for a specific guidance document to ensure consistency with quality control processes regardless of the quality specialist performing the review of subject charts, the Investigator Site File, and database information and/or the protocol or site selected for a quality check. The evolution of the IRA tool will also allow continuous tracking and trending of data and potentially identify other areas that should be included in the IRA. This tool is a living document that is updated on a monthly basis to capture new topics and to clarify existing topics. It may also be used to provide structured teaching to the research site when a deviation or quality issue is identified. I can’t think of a more important process in clinical research than ensuring that research participants are safe and that data is collected and documented per protocol, GCP, and regulatory requirements. The IRA is a much-needed part of the quality and compliance process and should help identify and mitigate risks in clinical research.


I have been in clinical research now for four years and have the best of both worlds. I still have an opportunity to collaborate closely with my patients in the clinic as well as assisting in finding alternative treatments when there are no other options and that is where the research part comes into play. Within clinical research there are many areas to venture into that are only going to expand my knowledge, experience, and abilities, but for my patients as well. It has always been my goal to be the best that I can be and continuing my education not only is a benefit to me, but for my patients as well. As an engineer for over ten years, I have much experience in ISO and Six Sigma standards and regulations, as well as creating SOP’s for compliance and quality within product and manufacturing within the company. So, it is only natural that when it involves the regulatory side of clinical research and dealing with an IRB that I would interest in learning more about the regulatory side of research. To me this is another way of providing and ensuring the safety of each of our patients during a study.

My capstone will involve assisting in the protocol development for a small clinical trial being conducted at the site of the PI pertaining to a class 1 medical device. This is a single arm study with a controlled placebo device. This handheld device will be used by individuals with chronic nasal congestion as an alternative and lower cost solution instead of medications, solutions, and/or other bulky devices. To assist in the development of this protocol is an amazing opportunity to jump in and get your hands dirty in an experience that you just dream about. It will state within these source documents the question or questions to be answered as well as how it will be achieved. The steps taken within this process will be ensured by the creation of SOP’s and required regulations that will be adhered throughout the study. This will not only ensure the patients safety, but the data collected will result in quality results.


Alan B Goldsobel, N. P. (2022, May 24). Prospective trial examining safety and efficacy of microcurrent stimulation for the treatment of sinus pain and congestion. Retrieved from National Library of Medicine: https://pubmed.ncbi.nlm.nih.gov/32232107/

Alyssa Cairns, R. B. (2022, May 24). The SinuSonic: reducing nasal congestion with acoustic vibration and oscillating expiratory pressure. Retrieved from National Library of Medicine: https://pubmed.ncbi.nlm.nih.gov/31695522/

Zachary M Soler, S. A. (2022, May 24). A novel device combining acoustic vibration with oscillating expiratory pressure for the treatment of nasal congestion. Retrieved from National Library of Medicine: https://pubmed.ncbi.nlm.nih.gov/32104962/


I started research projects as a student during Associates, my school required every third year student to conduct a research project, the student selects three areas and submits to their Research Supervisor for review and approval. I vividly remember that my coordinator required that I submit a background on the topic before she approved it. I wrote on Sexuality Education among teenagers, that started my journey in research. I loved the parts where I had to review what other writers had previously written on the topic (Literature review), I learnt more about the topic by reading various schools of thought. I became so interested in Sexual and Reproductive health, and I worked in the unit immediately after I graduated Nursing school.

Over the years, I have added more knowledge in Women’s health, Medsurg, Surgery amidst others, but the fact remains that I like reading and finding solutions to problems (I believe that is the purpose of research). Most problems are not new, they might just be new to an individual or community, someone somewhere may have gone through a similar situation. Then I read about unethical studies, and it left me unpleasantly surprised, how could anyone or organization do those things to humans? I realize that even in the 21st Century, the autonomy of people is still violated due to a variety of reasons. Informed consent and Autonomy are important in the conduct of research (Food and Drug Administration, 2019). Informed consent is not just a form that should be completed, it is a process. Participants of clinical trials should be given all the information they need to make a decision about (not) participating in the trial (FDA, 2019). From experience, people can become so zealous in the pursuit of their goals that they relegate the most important things (Informed Consent) to the background. Site staffs and Principal Investigators might be so engrossed in recruiting a lot of patients that they neglect to share all the risks and benefits of the study with the potential subjects, or recruit subjects who cannot comprehend the language that is being used. It is easy to get carried away, but the research team has a duty to ensure ethical conduct of research at all times.

Consent can only be deemed informed if the potential subjects are given required information before they accept or decline to participate in the study (FDA, 2019). It is imperative to make the informed consent process as seamless as possible for the patient. The pandemic has modified some parts of Clinical research e.g. e-consent. I intend to explore e-consent in my research project. I believe that appropriate Informed consent lends credence to the conduct of research and invariably improves integrity of the study.


Food and Drug Administration (2019, May 29). Informed Consent: Draft Guidance for IRBs, Clinical Investigators, and Sponsors. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent

Requirements: Per instructions

Subject: Health & Medical

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