Clinical esearch Administration
Embracing the scholar-practitioner (SP) model in clinical research represents a critical responsibility to improve, to inform, and to inspire the lives of others: improve through scholarly research, inform through practical application, and inspire through leadership. During the semester, awareness was heightened as to the importance of scholarly writing, theory implementation, and leadership influence. Being charged with such responsibilities is not for the faint of heart. Becoming independent scholars and critical thinkers who are ready to forge ahead in making valuable contributions to one's fields of expertise requires a great deal of dedication, tenacity, and vision to cultivate a new body of knowledge (Dietzmann, 2005). To become successful, one will need to engage in scholarly writing, which is the basis for the SP model. Without academic integrity, effective writing skills, and synergistic teamwork communicating new knowledge and influencing implementation will not be possible in clinical research.

Academic Integrity

Demonstrating responsible academic…...

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References

Diezmann, C.M. (2005). Supervision and scholarly writing: writing to learn -- learning to write. Reflective Practice, 6(4), 443-457. doi:10.1080/14623940500300491

Girard, N.J. (July 2004). Plagiarism: an ethical problem in the writing world. AORN Journal, 80(1), 13-15. Retrieved from Gale.

Hatcher, T. (2011). Becoming an ethical scholarly writer. Journal of Scholarly Publishing, 42(2), 142-159. Retrieved from EBSCOhost.

Lunenburg, F.C. (2010). Creating a professional learning community. National Forum of Educational Administration & Supervision Journal, 28(1), 1-7. Retrieved from EBSCOhost.

Clinical esearch Ethics
Medical research is the most sensitive field of research in the entire field of academia. It is governed by several rules, regulations, and ethical standards. For instance, no research endeavor is allowed in case it hurts the life of any human being whether directly or indirectly. Secondly, any research that is to be done must meet environmental conservation measures and should not deride or harm human dignity in any way. Besides, no research in the medical field is allowed in case it results in the extinction of an entire species of the sample used be it plants or animals. easonably, this ensures that there is no or little alteration to the ecosystem (Kapp, 2006). The environment that species live in is also guarded against any negative effects of the research. In this regard, any research that is deemed to have harmful effects on the entire, or a larger…...

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References

Ethics in International Research. (1999). The Debate Over Clinical Trials of AZT to Prevent Mother-to-Infant Transmission of HIV in Developing Nations. Ethics in International Research

Kapp, M.B., (2006). Ethical And Legal Issues In Research Involving Human Subjects: Do You Want A Piece Of Me? J. Clin Pathol. Apr 2006; 59(4): 335 -- 339.

Maschke, K.J. (2008). Human Research Protections: Time for Regulatory Reform? Hastings Cent Rep. 2008 Mar-Apr;38(2):19-22.

Perrone M. (11/16/2014). Ebola Drug Testing Sparks Ethics Debate: Medical views diverge on how to ethically test Ebola drugs in Africa. The Associated Press

Nurse led clinical research: neonatal nurses' perceptions and experiences
The aims of the study are to understand the experiences of clinical nurses in conducting and utilizing clinical research within their neonatal setting.

This is a qualitative study of five neonatal nurses who were interviewed using semi-structured, face-to-face interviews to obtain the study data. This was a phenomenology-based study, which means it was meant to study the overall structure of the nurses experiences (Husserl 1962).

This study explored and examined the presuppositions of the nurses being interviewed. Specifically, the researcher wanted to probe for attitude and barriers to research participation within the neonatal setting. The second key feature was the researchers intentional selection of nurses for the study. The research chose nurses from two designated neonatal metropolitan nurseries. The final key feature was that nurses were interviewed away from their work setting and open ended questions were used for the interview.

The research design is…...

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Works Cited

Moustakas, Clark (1994). Phenomenological Research Methods. California: Sage Publications.

Husserl, Edmund (1962). Ideas: General Introduction to Pure Phenomenology, Translated by W.R. Boyce Gibson. London, New York: Collier, Macmillan.

Russell, Cynthia & Gregory David (2003). Evaluation of qualitative research studies. Evidence-Based Nursing, 6, 36-40.

Strauss, Anselm & Corbin, Juliet (1990). Basics of Qualitative Research: Grounded Theory Procedures and Techniques. New York: Sage Publications.

oles of Clinical esearch Team Members
The relevance of a competently constituted clinical research team cannot be overstated when it comes to the success of clinical trials. This is true for both a site-based clinical research team and a sponsor-based clinical research team.

Sponsor-Based Clinical esearch Team

Data Coordinator

According to obinson (2009, p. 9), "the primary role of a data coordinator is to ensure that the clinical trial database is accurate and complete, ready for data analysis."

Education equirements

A degree in a biological science (obinson, 2009)

Professional Skills

Some of the most important professional skills a data coordinator ought to possess are "an eye for detail and methodical approach" (obinson, 2009, p. 9).

Experience equirements

Like any other key role in clinical research, experience in this case does matter. In most cases, 2-3 years worth of experience is deemed sufficient.

Interpersonal Skill equirements

According to obinson (2009), of key relevance to this position is the ability to communicate well with…...

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References

Fedor, C.A., Cola, P.A. & Pierre, C. (2006). Responsible Research: A Guide for Coordinators. Remedica.

Robinson, M. (2009). How to get a Job and Manage your Career in Clinical Research. Institute of Clinical Research.

Stakeholders in Clinical esearch Trials
There are various stakeholders involved in clinical trials. These include, but they are not limited to, funding agencies, the patient, the government, regulatory and oversight boards, the general public, insurers (if any), and the industry. In essence, these stakeholders not only influence, but also contribute to the process as well as outcome of clinical trials in a variety of ways. Below, I concern myself with three key stakeholders: the government, industry, and the subject.

Government: the government is actively involved in the regulation of clinical trials. It is important to note that typically, the government plays the regulatory role through various federal agencies such as the Food and Drug Administration - FDA. FDA, for instance, plays an active role in trials that involve "new drugs or significant new uses for already-approved drugs, through the Investigation New Drug (IND) Application process" (Institute of Medicine, 1999, p. 4). For…...

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References

Gelband, H. (1999). A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Mechanisms. Washington, DC: National Academies Press.

Kutz, G.D. (2009). Human Subjects Research: Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation: Congressional Testimony. Darby, PA: Diane Publishing Co.

National Institutes of Health -- NIH. (2014). FAQs About Clinical Studies. Retrieved from  http://clinicalcenter.nih.gov/participate/faqaboutcs.shtml

Volunteering for a Clinical esearch Trial
People accept to participate in clinical trials as volunteers for a number of reasons. In addition to fulfilling that inherent desire to help others, most people feel that participating in such trials helps move science forward (National Institutes of Health - NIH, 2014). Clinical trials, in essence, "look at new ways to prevent, detect, or treat disease" (NIH, 2014). Personally, I have never participated in a clinical trial. Neither has any member of my family, or friend to whom I'm closely acquainted.

It is important to note, from the onset, that if I met the criteria for a future trial, I would most definitely participate in the same. I would volunteer because deep inside, I feel that this would be good for humanity. Diseases bring about a great deal of misery and suffering to people, confining some to their beds forever, causing others to die miserable…...

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References

Fitzpatrick, S. (Ed.). (2005). The Clinical Trial Protocol. Marlow, Buckinghamshire: Institute of Clinical Research.

National Institutes of Health -- NIH. (2014). NIH Clinical Research Trials and You. Retrieved from  http://www.nih.gov/health/clinicaltrials/basics.htm#3

monitoring and the role of clinical monitor have become the focus of a growing amount of attention in recent years due to the centrality of these functions to the success of research studies. This paper reviews the literature to determine why the clinical research associate (CA)/clinical monitor is the most important contact that a site has with a sponsor, how the monitoring function can contribute to the success or failure of a study and what CAs can do to maximize the effective of their monitoring strategy. Finally, a summary of the research and important findings concerning these issues are presented in the conclusion.
Why is the clinical research associate (CA)/clinical monitor the most important contact that the site has with the sponsor?

Although every study setting is unique, CAs are generally tasked with the supervision and support of the administration of a clinical trial and monitoring its progress for a sponsor…...

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References

CRA certification. (2015). Association of Clinical Research Professionals. Retrieved from  http://www.acrpnet.org/MainMenuCategory/Certification/CRACertification.aspx .

Hurst, C. & Dennis, B. P. (2013, Fall). Developing a clinical research associate training program at Dillard University: The impact of collaboration. ABNF Journal, 24(4), 104-109.

Goals
Thank you in advance for your consideration of my application to become a scholar-practitioner at alden University. My goals dovetail ideally with alden's mission statement and I have always been an eager, quick learner thirsty for opportunities to help other people while bettering and challenging myself. I know that the alden experience will challenge me and that is exactly what I expect and look forward to.

I pursue the field of clinical research because I know I am competent to work in this field and moreover, I consider the opportunity to participate in research that can potentially improve the lives of millions of people an exciting and wholly worthwhile endeavor. Helping to transform our society, which faces so many health-related issues, is a goal I approach with clarity and deep concern. hether it is finding remedies and solutions for heart disease, for breast cancer, or genetic disorders -- or, in…...

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Works Cited

Walden University. (2014). M.S. In Clinical Research Administration. Retrieved November 3

2014, from http://info-waldenu.edu.

At ____, I served for a year as Editor in Chief for the North American Students Association (NASA), two years as NASA Vice-President for the UAG Student Body, and three years as class president. I was also elected by university officials to represent the UAG at the National AMSA Conventions in Washington DC, and Chicago, IL. I was fortunate enough to receive medical accreditation at the federal level and to be awarded the certificate as best Medical Pasante in the ____ Region.

In ____, I managed to acquire the donation of an ambulance [for/from] the ____ [from/for] the City of Laredo, Texas. Finally, some of the work from which I derived the most personal satisfaction was in connection with teaching 5th and 8th Grade Spanish at the University of Incarnate Word, in Guangzhou, China.

Personal Qualities

I have developed an in-depth knowledge of medical treatment processes and terminologies and possess a fluent command…...

Participation in Clinical esearch Trial: Strategies esearchers Use to Increase ecruitment for the Studies
Strategies esearchers use to Increase ecruitment for their Studies

In order to conduct successful qualitative research, researchers need to recruit the right participants for clinical trials. However, there are many setbacks when it comes to identification and recruitment of these participants due to various problems, such as differing personal preferences, ineffectiveness of the research methods used, demographics, and character traits of the target population. According to Funa and colleagues (2014), one effective strategy that can be used to increase research participants is to fully understand the target population. They state that differences in cultures, education levels, and values may discourage the participants, and researchers need to take time to discover the topics they are sensitive to, what they believe in, and the level of education they have attained. However, the effectiveness of this strategy is not guaranteed…...

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References

Funa, N.A., Rimando, M., B, Christiana, A.M., Fowles, R.W., Davis, T.L., Martinez, L.M., & Sealy, D. (2014). Recruitment in qualitative public health research: Lessons learned during dissertation sample recruitment. The Qualitative Report, 19(1), 1-17. Retrieved 13 March 2015 from  http://www.nova.edu/ssss/QR/QR19/namageyo-funa1.pdf 

Insight Medical Publishing Limited (2012). World Health Report 2012: No Health Without Research. Thematic Collections. Vol. 2(1) 113-126

Purdue University (2014). Recruitment of Human Participants. The Purdue University Library. Retrieved 14 March 2015 from  https://www.irb.purdue.edu/docs/Guidance_Recruitment_of_Human_Participants.pdf

Contract esearch Organizations eality
There are numerous reasons that can explicate the fact that contract research organizations or COs have become so popular of late in the conduct of clinical trials. Some of these pertain to basic financial necessities. The prices of materials used in clinical trials and in the pharmaceutical business in general are increasing. According to Forbes (2011), "A survey by W Baird analyst Eric Coldwell found 42% of this year's drugmakers say prices rose in this year's second quarter, up from one-third in the first quarter." Thus, because the basic materials involved in testing for pharmaceuticals has increased, outsourcing this process has become a much more viable option for those looking to conduct clinical trials.

Additionally, it is critical to note that in certain instances organizations are cutting back on their expenses. Such a statement certainly applies to pivotal aspects of research and development. In fact, there are several…...

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References

Silverman, E. (2011). Why contract research organizations are so hot. Forbes. Retrieved from  http://www.forbes.com/sites/edsilverman/2011/10/04/why-contract-research-organizations-are-so-hot/ 

Silverman, E. (2013). What contract research organizations are doing to keep employees. Forbes. Retrieved from  http://www.forbes.com/sites/edsilverman/2013/08/19/what-contract-research-organizations-are-doing-to-keep-employees/

Prison Condition in USA vs. ussia
In assessing the human rights conditions of maximum security facilities, human rights groups look into 3 main areas: the duration of confinement; the conditions of confinement, and the criteria of eligibility. Each of these areas must be looked into individually and then considered in the context of the entire situation (Human ights Watch). Quite a number of concerns have been raised about the human rights conditions of the individuals held in prisons including: mistreatment of inmates / detainees by prison officials; unsafe conditions; and lack of sufficient legal protection (United States Department of State, n.d.). This paper also compares the situation of prison facilities in the United States and ussia.

Introduction

The Standard Minimum ules, or the SMs for the Treatment of Prisoners are one of the most important international agreements on how prisoners should be handled. The SMs were adopted in 1955 by a special United…...

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References

Hounshell, B. (2010). What are Russian prisons like? Retrieved March 15, 2016 from  http://foreignpolicy.com/2010/12/28/what-are-russian-prisons-like/ 

Human Rights Watch (n.d.). Supermax Prisons: an overview. Retrieved March 15, 2016 from  https://www.hrw.org/reports/2000/supermax/Sprmx002.htm#TopOfPage 

Markovic, V. (2000). Maximum Security Prisons: A Comparative Analysis. CRIME AND JUSTICE INTERNATIONAL, 16(39), 9-10.

Rosen, A. (2012). Inside Russia's Prison System. Retrieved March 15, 2016 from  http://www.theatlantic.com/international/archive/2012/10/inside-russias-prison-system/263806/

Letter to Support the Genetic Information Nondiscrimination Act of 2008 (GINA)
The Genetic Information Nondiscrimination Act of 2008 (GINA) is an Act of U.S. Congress that makes it illegal for employers and health insurance companies to use genetic information against an individual. For instance, if a person has a genetic predisposition to a particular disease that runs in his or her family tree, an insurer is not allowed to use that information as a reason for denying coverage to that person. Likewise, a company may not discriminate against individuals based on their genetic information. GINA also has implications beyond either of these two instances. This letter will discuss why it is important that GINA be supported by Americans and their representatives in Congress.

Body

The first reason GINA should be supported is that it does help to protect individuals from discrimination by health insurance providers. A genetic predisposition to a particular disease…...

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References

GINA. (2008). U.S. Equal Employment Opportunity Commission. Retrieved from  https://www.eeoc.gov/laws/statutes/gina.cfm 

National Human Genome Research Institute. (2015). Genetic Discrimination. NIH.

Retrieved from https://www.genome.gov/10002077/genetic-discrimination/

Patent Protection on Clinical esearch: The Primary Sources of Innovation in the Drug and Device Development Process
When it comes to biopharmaceutical research, the United States is the best country in the world and it is currently the largest pharmaceutical market. It has invested immensely in research and development, especially in the biopharmaceutical sector, and it holds numerous intellectual property rights for a majority of the drugs developed. According to the U.S. Food and Drug Administration, FDA (2014), all drug companies have to seek the organization's approval before they sell new drugs, and these drugs have to be tested accordingly to guarantee the safety of the public. Adherence to these requirements often makes markets increasingly competitive and in the recent past, the increasing demand for innovation in pharmaceutical companies has necessitated new approaches to be applied in the drug and device development process. This is particularly because pharmaceutical companies have…...

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References

Gold, R, E., Kaplan, W., Orbinski, J., Logan, S.H., & Marandi, S.N. (2009). Are Patents Impeding Medical Care and Innovation? PLoS Medicine Vol. (7)1 e1000208. Retrieved 13 March 2015 from http://www.plosmedicine.org/article/fetchObject.action?uri=info:doi/10.1371/journal.pmed.1000208&representation=PDF

The United States Food and Drugs Administration (2014). FDA Basics. About FDA. Retrieved 13 March 2015 from  http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194949.htm

QuintilesIMS services the healthcare industry and plans on expanding their reach internationality. Turkey is a country that has experienced changes in recent years. They offer universal healthcare with private health insurance options for individuals. The county is also looking for foreign investors within their healthcare sector, presenting a great opportunity for growth for the company.
Quest Diagnostics is also looking to expand and they offer laboratory services and information for clinical trials. Thanks to deregulation of clinical trials, more clinical trials may be formed without need for extensive research and concise data. Quintiles IMS is a data-driven company that has recently experienced a megamerger and has yet to eliminate or introduce all of their services. Quest Diagnostics has remained fairly stable and could provide options for Turkey faster than QuintilesIMS. However, the company can beat their competition through their data-driven approach.

They have the technological innovation Quest Diagnostics lacks as well as…...

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References

Bel lHolding. (2017). VALUES | Bell Holding. Retrieved from http://www.bellholding.com/en/11-degerler/

CBS News. (2017, May 22). Turkey protests "aggressive" U.S. action in embassy clash - CBS News. Retrieved from  http://www.cbsnews.com/news/turkey-protests-aggressive-us-action-over-embassy-clash/ 

Frost & Sullivan. (2017, February 12). Global Healthcare Industry Outlook, 2017. Retrieved from  https://www.frost.com/c/10024/sublib/display-report.do?id=K152-01-00-00-00 

Gloor, P. (2012). Making the e-Business Transformation. Springer Science & Business Media.

Health Record Utilization in Research and Data Analysis

Health records, traditionally used for patient care, can be a valuable asset for research and data analysis. Their comprehensive and longitudinal nature provides insights into health trends, treatment patterns, and patient outcomes.

Research Applications of Health Records

- Clinical Research: Studying the effectiveness of new treatments, comparing different medications, and identifying risk factors for diseases.
- Epidemiological Studies: Investigating the spread and distribution of diseases, monitoring health trends, and identifying at-risk populations.
- Health Outcomes Research: Evaluating the impact of healthcare interventions and policies on patient health and well-being.
- Big Data Analysis: Aggregating and analyzing health records....