Learning Objective This group formative assessment will test your understanding of multiple aspects of clinical trials,
Posted: Thu Mar 31, 2022 8:00 am
- Learning Objective This Group Formative Assessment Will Test Your Understanding Of Multiple Aspects Of Clinical Trials 1 (171.64 KiB) Viewed 126 times
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Learning Objective This group formative assessment will test your understanding of multiple aspects of clinical trials, including types, design and phases. This assignment will test your ability to apply good clinical practice in a clinical trial in the industry. Assignment Topic You will be submitting a written component and you will be presenting your assignment to the class. You will be required to set up a clinical trial for a pharmaceutical product of your choice. This product can be a new drug you wish to test or an existing drug for the treatment of a disease/condition not initially intended for treatment You need to ensure that you follow and apply all clinical trial practice guidelines that you have been taught in class. Scope This is a group project comprising five to six members per group. This assignment will have two components: Written assignment When designing your clinical trial, you need to pay close attention to the following: • Your clinical trial must adhere to the principles set out in the Nuremberg Code, Declaration of Helsinki as well as the International Conference of Harmonisation. • The type and design selected for your trial must be appropriate and a clear discussion on why you chose that specific type and design. Briefly outline the phases of the clinical trials and what participants will be included and excluded from your trial. Outline the financial implications/requirements of your trial. • Outline and discuss the key role players in your trial and the importance thereof. • Discuss how the trial will be monitored. Highlight the important documentation needed for your trial, include a draft of one document in the appendix of your assignment. . .
Assignment Topic You will be submitting a written component and you will be presenting your assignment to the class. You will be required to set up a clinical trial for a pharmaceutical product of your choice. This product can be a new drug you wish to test or an existing drug for the treatment of a disease/condition not initially intended for treatment. You need to ensure that you follow and apply all clinical trial practice guidelines that you have been taught in class. Scope This is a group project comprising five to six members per group. This assignment will have two components: Written assignment When designing your clinical trial, you need to pay close attention to the following: • Your clinical trial must adhere to the principles set out in the Nuremberg Code, Declaration of Helsinki as well as the International Conference of Harmonisation. • The type and design selected for your trial must be appropriate and a clear discussion on why you chose that specific type and design. Briefly outline the phases of the clinical trials and what participants will be included and excluded from your trial. • Outline the financial implications/requirements of your trial. • Outline and discuss the key role players in your trial and the importance thereof. • Discuss how the trial will be monitored. Highlight the important documentation needed for your trial, include a draft of one document in the appendix of your assignment. .