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CTA Prototype Assignment Weight: 20% of Final Grade As discussed in class, in order for a clinical trial to be conducted in Canada, a Clinical Trial Application must be filed and approved by Health Canada before it can begin. As a regulatory affairs associate working for a large multinational pharmaceutical company, you have been asked to prepare a CTA for a new oncology product named “Sheridanumab”. The proposed study is for “An Open-label, Multicenter, Single-arm, Phase II Study of Sheridanumab in Patients with Germline BRCA1/2 Mutation and Platinum-sensitive Recurrent Ovarian Cancer”. You have previously held a pre-CTA meeting with Health Canada and have been given the green light to proceed with a CTA. 1. Create a prototype of your CTA, listing all relevant documents that you would need to file and what CTD section it would go in. If a CTA section does not apply, please indicate N/A. Please organize your Modules using the following tabular format:
2. Indicate what guidance document(s) you used to determine how to build your CTA prototype. 3. Summarize the differences between a CTA and IND.
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An instance of a confidence interval can be observed in a medical journal, news article, or scholarly source. Summarize the study or article. Are the
An instance of a confidence interval can be observed in a medical journal, news article, or scholarly source. Summarize the study or article. Are the sample size and level of confidence utilized in constructing the confidence interval disclosed in the article or study? Elucidate the significance of the confidence interval