The Small Business Act (Essay) - 550 Words

Contract Administration and Management. The Small Business Act (Essay Sample) Content: Running Head: CLINICAL TRIALSClinical trials and their benefitsNameCourseInstitutionTutorDateClinical trialsDefinitionClinical trials are studies done to carry out an assessment determining the viability of a medical strategy, treatment, or devices. They assess the effects created if such strategies are implored to a human subject. The studies are carried out to show the best-recommended approach that work best for various illnesses or a certain group of individuals (Yang, 2010). The studies are also effective in helping carry out a decision or effecting a decision based on outcome of the study. The trials are conducted only when satisfactory information available to match health authority standards. Research specialists enroll volunteers or patients into pilot studies to conduct specific tests depending on the product type and development stage (Yang, 2010). Clinical trials vary in intensity. They can be performed in a single country or multiple countries. They are expensive to carry out. The burden of payment is usually bestowed on the sponsor of the research. Sponsors may include government agency or health organizations (Yang, 2010).Functional rationaleThe objectives of clinical trial are to test how well medicine will work on patients. For every clinical trial, there exists a guideline of how to carry out the trial (Yang, 2010). The plan discusses what is to be done, how it will be done, and the importance of all aspect in the study. This includes the importance the general study. There are rules guiding on how to choose the participants in the study. The main factor in choosing the participants is volunteering when a person has sufficient knowledge (Pocock, 2004). They volunteer's health status will be determined by the study since some may need healthy individuals and others may need individuals with certain diseases (Pocock, 2004).In other instances, gender is used to determine a viable volunteer. There are independent committees set to determine the procedures and monitor the whole exercise. These committees are made up of physicians, statisticians, and members of the community. The committee emphasizes the need to educate all the subjects liable to tests so that they can know the effects of every aspect of the trials (Pocock, 2004). In so doing, the subjects will be well aware of the risks involved such that volunteering shall be out of free will. Since the tests are conducted to human subjects, they are eligible to many legal aspects (Pocock, 2004). They are carried out in four phases. Because the life of an individual may be at risk during the trials, the law provides strict guidelines that facilitate a safe environment for the subject (Pocock, 2004). The shared responsibilities for the safety of the subject heighten safety measures during actual studies. In most cases, women are not subjected to these trials because of several reasons. These reasons are either the woman is in the age of childbearing, is preg nant, and/or she becomes pregnant during the study. Local site investigators carry out continuous assessments to determine the safety of the subject (Pocock, 2004...