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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:

CTD Module/Section

Document(s) you would provide in the section – if there are specific forms that need to be completed, please list which ones

1.1 Table of Contents

E.g. a table of contents for Modules 1-3

1.2.1 Drug Submission Application Form

1.2.2 Information on Prior-related applications

Etc.

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:
• The Prototype project should follow the APA format with font size 12 and 1.5 spacing, Times New Roman.
• Provide each question and your response following it. Include all references.
• A title page should be included in addition to the page limit. The title page should contain informtion such as Student Name, Student ID, Prototype title, course code etc.
• The marking rubric is atached for your reference.

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