Clinical Research Investigator

Question: Describe about the major responsibilities of a clinical research investigator? Answer: Introduction: Clinical research is a research which requires group of people to examine the safety, tolerance, dose and action of a drug. Clinical research obeys a pre- planned protocol. Clinical trial is also known as clinical research. A clinical investigator regulates the full method of clinical research. And the clinical investigator is responsible for all the process. Clinical investigators have so many responsibilities. And the investigator should follow them to get a perfect and appropriate result of the clinical research. It is mandatory to check and follow the plan of clinical research because a fail of clinical research means wastage of huge money. So all the member who are associated to clinical research should have enough knowledge to achieve the goal. Body: The clinical investigators regulate good clinical practice. The clinical investigators prepare a design of the clinical research and also maintain the quality of the clinical research. A good clinical practice is delivered by International Conference of Harmonization Guidelines (investigator responsibilities - regulation and clinical trials, 2015). Good Clinical Practice is a standard for conduct, monitoring, design, performance, reporting, auditing of clinical trials that produces guarantee that the reported results and data are believable and precise. The design of clinical trial certifies the integrity and quality of data which are assembled in clinical trial and also secures the safety, rights and welfare of participants of research. The whole clinical research is performed in the supervision of the clinical investigator. The clinical research investigator is an independent person who actually organizes a clinical research. By the instant direction the new drug is distribut ed to a subject (Guidance for Industry Investigator Responsibilities Protecting the Rights, Safety, and Welfare of Study Subjects, 2015). The investigation is regulated by a team of persons and the head is the clinical research investigator in the whole team. The investigator is also responsible for each of the opinion of the whole team. The investigator conducts and begins the investigations. The clinical research investigator has the power to control and stop the research immediately. The clinical research investigator should have appropriate knowledge to perform, conduct, design, monitoring the whole research. It is the responsibility of the clinical research investigator to supervise and conduct the research process. The investigator should inform the subject initially that it is the investigational process of new drug development. The clinical research investigator has some general responsibilities, and also they control the drug which is used for the research (Ccr.med.keio.ac .jp, 2015). It is the responsibility of the clinical research investigator to keep the record and hold the record for further investigation. The clinical research investigator should maintain the sufficient record of the character of the drug. It is the responsibility of clinical research investigator to keep all clinical data and also precise case history. The investigator should maintain the data appropriate to the investigation on each person administered and also investigational drug which is used as control (Baer et al., 2011). An investigator is needed to preserve all the clinical record data. The clinical trial data are preserved for two years because two years are required for the approval of the marketing application for the investigational drugs. The drug is investigated for the approval of marketing application. After two years the investigation is terminated if the marketing application is not approved. There are four investigator reports. And the reports are safety repo rts, progress report, final report and financial disclosure. It is the responsibility of the investigator to cover any adverse effects that is shocking or life threatening or serious or surprising. The clinical research investigator punctually covers any adverse event which is caused by the drug (roles and responsibilities in clinical trial, 2015). The clinical research investigator responsibilities are control of investigational drug, record holding and keeping and report forming. The clinical research investigator is disqualificated if the frequently intentional failure is observed. So the responsibility of the investigator is very important. Food and Drug Administration delivers a notice to the clinical research investigator and gives a chance to explain. Conclusion: The responsibility of the clinical research investigator is very crucial. And the clinical research investigator is responsible for the whole process (Nichd.nih.gov, 2015). A set of people or a specific person in required in clinical research. Their actions or tissues are needed for the study of clinical research. So the full method is very critical to handle. And the responsibility of a investigator is very important because the whole method of clinical research depends on the clinical research investigator. A predefined procedure or a master plan is needed for developing a clinical research. And this predefined procedure or master plan is created by the clinical research investigator. So the responsibility of the clinical research investigator is very important and significant. References: Baer, A., Devine, S., Beardmore, C. and Catalano, R. (2011). Clinical Investigator Responsibilities.Journal of Oncology Practice, 7(2), pp.124-128. Ccr.med.keio.ac.jp, (2015).Module 3: Investigator Role Responsibilities. [online] Available at: https://www.ccr.med.keio.ac.jp/e_learning/UM_E-Learning_US/mod03/index.html [Accessed 10 Mar. 2015]. Guidance for Industry Investigator Responsibilities Protecting the Rights, Safety, and Welfare of Study Subjects. (2015). [online] Available at: https://www.fda.gov/downloads/Drugs/.../Guidances/UCM187772.pdf [Accessed 10 Mar. 2015]. investigator responsibilities - regulation and clinical trials. (2015). [online] Available at: https://www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM283301.pdf [Accessed 10 Mar. 2015]. Nichd.nih.gov, (2015).Clinical Trials Clinical Research. [online] Available at: https://www.nichd.nih.gov/health/clinicalresearch/Pages/index.aspx [Accessed 10 Mar. 2015]. roles and responsibilities in clinical trial. (2015). [online] Available at: https://www.centerwatch.com/pdfs/s11604_ch4.pdf [Accessed 10 Mar. 2015].