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Instructions |
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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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Medicaid is partially federally funded and partially state-funded. As we all know, not every State is equal in per capita income, and the number of
Medicaid is partially federally funded and partially state-funded. As we all know, not every State is equal in per capita income, and the number of poor and disabled is equally unbalanced. Under the Affordable Care Act (ACA), Medicaid funding was expanded, yet some states opted out of accepting the
