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Module: Clinical Research Management (level 9) Assignment Title: Case study of a Phase III Clinical Trial Instructions: Choose a therapy area or disease that you are interested in. Find a phase III clinical trial that has been completed and reported in this area and read up on all the relevant/published information you can find. Write a concise summary of the trial you chose, highlighting the following: Title and reference numbers and objectives framework and model used in trial endpoints/outcomes of trial safety and side effects results of the trial This will allow us to see that you have a good understanding of the clinical trial Answer the following questions about the trial: What worked well about this trial? What did not work well in this trial? If you were the PI, what changes would you make to this trial? This will allow us to see that you can critically analyse the clinical trial and give your own opinions Give a list of your references. Use Zotero and Harvard referencing and find reputable and relevant sources for your information e.g. www.clinicaltrials.gov, www.clinicaltrialsregister.eu and https://www.ema.europa.eu/en/medicines as well as academic databases. Deadline Sunday 3rd April 2022 @ 11pm Rules and Guidelines: Submit pdf file of assignment through Turnitin on Moodle by Sunday 3rd April 2022 @ 11 pm. A maximum of three submissions are allowed – each version overwrites the previous one. A similarity value of more than 30% will be investigated further and marks may be deducted. Please sign and submit a cover sheet with your assignment (attached below). Plagiarism of any kind will not be tolerated. At best, any plagiarised sections of the assignment will be excluded from marking and at worst, a case of academic misconduct will be initiated (which could result in sanctions). No extensions will be allowed and late submissions will be subject to penalties (10% loss of awarded marks for up to one week late, 20% loss of awarded marks for up to two weeks late and a cap of 40% on anything submitted over two weeks late). Marks will be awarded under the following headings – see rubric below for details.
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