Hide Assignment Information | ||||||||||
Turnitin™ | ||||||||||
This assignment will be submitted to Turnitin™. | ||||||||||
Instructions | ||||||||||
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.
General Instructions: | ||||||||||
Learning Theories Principles and Quality Health Care The advanced practice nurse role is a career in which the advanced practice
Learning Theories & Principles and Quality Health CareThe advanced practice nurse role is a career in which the advanced practice nurse must learn any new theories and principles and apply them to every aspect of their career. Teaching new theories and principles is the main guide for educational systems so