Our Services

Get 15% Discount on your First Order

Hide Assignment Information Turnitin This assignment will be submitted to Turnitin.

March 7, 2024

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:

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.

image1.gif

>Applied Sciences homework help

Share This Post

Order a Similar Paper and get 15% Discount on your First Order

Related Questions

4/2/24, 9:47 PM Case – HRM402 Training and Development (2024MAR04FT-1) 1/3 Module 3 – Case LEARNING STYLES; DEVELOPMENT OF TRAINING Assignment

4/2/24, 9:47 PM Case – HRM402 Training and Development (2024MAR04FT-1) 1/3 Module 3 – Case LEARNING STYLES; DEVELOPMENT OF TRAINING Assignment Overview Signature Assignment: Body of Knowledge, Introduced level In this assignment, your knowledge skills will be assessed at the “introduced” level. In MGT411, they will be assessed at the

1 Juvenile Court Probation Officer Report on Jennifer Scott’s Case Simone Ross Working with Juvenile Offenders December

1 Juvenile Court Probation Officer Report on Jennifer Scott’s Case Simone Ross Working with Juvenile Offenders December 8, 2023 Juvenile Court Probation Officer Report on Jennifer Scott’s Case Jennifer Scott, a 15-year-old bi-racial female with ADHD, Substance Abuse Disorder (Marijuana), Conduct Disorder, and Post-Traumatic Stress Disorder, is currently facing juvenile

Identify the research question(s) for this study. Provide a critique of the conceptual underpinnings/research tradition of this study. Provide a

Identify the research question(s) for this study. Provide a critique of the conceptual underpinnings/research tradition of this study. Provide a critique of the research design. Please provide critique and answer these 3 questions based off the article attached. must contain at least two citations with corresponding reference

Complete both sections of this assignment please. Cognitive Development Activities For this assignment, use the Cognitive

Complete both sections of this assignment please. Cognitive Development Activities For this assignment, use the Cognitive Development Activities template to create three standards-based instructional activities. Refer to Piaget’s stages of cognitive development theory, Gardner’s theory of multiple intelligences, or Kohlberg’s theory of moral development to guide the design of your

As we read and talk about generalization, identify 2 specific concepts from this week’s readings and video that you can use in your current position.

As we read and talk about generalization, identify 2 specific concepts from this week’s readings and video that you can use in your current position. Share with your classmates what your current position is (behavioral analyst), and how you can use those two concepts. Be sure to reference and cite

Assignment Overview Communication Effective communication boosts productivity, fosters teamwork, reduces

Assignment Overview Communication Effective communication boosts productivity, fosters teamwork, reduces misunderstandings, drives employee engagement, and improves decision-making to build a successful workplace culture. **Complete SLP 3 before Case 3** Session Long Project 3 Resources 13 Strategies For Breaking Down Silos And Boosting Interdepartmental Communication (2023) How to Improve Cross-Functional Communication

Assignment Overview The Diverse Workplace Cultural Intelligence (CQ) drives understanding across diverse

Assignment Overview The Diverse Workplace Cultural Intelligence (CQ) drives understanding across diverse backgrounds and enhances workplace inclusion. Diversity brings varied perspectives, but challenges may arise from misunderstandings and biases. Inclusion, propelled by CQ, ensures diverse talents are harnessed, fostering innovation and collaboration despite inherent workplace challenges. Complete SLP 3 before

Description It is important to understand all of the functions within a particular supply chain. Although most supply chains do have similar functions,

Description It is important to understand all of the functions within a particular supply chain. Although most supply chains do have similar functions, the structure and elements can vary greatly. Therefore, it is important for you to not only be able to identify the various functions within a supply chain,

Instructions attached Summary-Response September 12, 2018 WRTG 111 Summary Response #3 Article #1: ” Financial Health is Public Health”

Instructions attached Summary-Response September 12, 2018 WRTG 111 Summary Response #3 Article #1: ” Financial Health is Public Health” (Jason Q. Purnell) Summary: In the reading selection for this week, “Financial Health is Public Health”, Jason researched that seventy-two percent of adults worried about money “at least some of the

EXAMPLE ONE: Search Procedure A systematic review of the literature for behavioral feeding interventions with children that did not include

EXAMPLE ONE: Search Procedure A systematic review of the literature for behavioral feeding interventions with children that did not include escape extinction or other intrusive interventions was conducted in accordance with the PRISMA guidelines (Moher et al., 2009). The PRISMA model entails four tiers: (1) identifying articles, (2) screening articles,

I’m particularly fond of the high-quality graphics and animations that Slots City offers in their slot games. It’s not just about the chance to win;

I’m particularly fond of the high-quality graphics and animations that Slots City offers in their slot games. It’s not just about the chance to win; it’s the immersive experience that makes me return. Additionally, being able to play on my Android device without any hitches is a big plus for

In this module, we have discussed a couple of specific work performance issues and the protocols supervisors should apply in resolving them. In this

In this module, we have discussed a couple of specific work performance issues and the protocols supervisors should apply in resolving them. In this project, please demonstrate your understanding of addressing staff performance problems in an appropriate and effective manner. Select one of the below frequently occurred staff issues, Frequent

Background Readings Urich, A., & Open Textbook Library. (2023). Methods for stress management.

Background Readings Urich, A., & Open Textbook Library. (2023). Methods for stress management. Pennsylvania State University. Chapter 1 Stress Chapter 10 Implementing a Stress Reduction Plan Carr, D. (2014). Introduction: What is stress? Worried sick (DGO – Digital original ed., pp. 1). Rutgers University Press. Chapter 2: Sweating the Small

How have your life and professional experiences prepared you for the WGU B.S. Nursing Prelicensure program?  Previous experience  Educational

How have your life and professional experiences prepared you for the WGU B.S. Nursing Prelicensure program?  Previous experience  Educational background  Community involvement  How can the WGU nursing program prepare you to deliver and/or support healthcare to the community in which you live?  Tell us about the characteristics, abilities, and skills

This is what I sent but the instructor said I did not follow the Rubic. Please work on improving it for me. ABA

This is what I sent but the instructor said I did not follow the Rubic. Please work on improving it for me. ABA 520 Module 6 Project Behavior Skills Training Proposal One day of professional development will be provided to the Outreach Program (the RBTs employed by the local school

Petroleum 1.0.1.. mid-term. Name: 1 The following test is a mix between (multiple choices and true or false statement): Answer 40 questions

Petroleum 1.0.1.. mid-term. Name: 1 The following test is a mix between (multiple choices and true or false statement): Answer 40 questions . ————————————————————————————————————————– 1.The company’s successful advertising campaign resulted in a substantial pay rise for the marketing executive. 1. A: marketing executive 2. B: accountant 3. C: landman 2.The

3/25/24, 5:11 PM Case – MGT407 Principles of Human Resource Management (2024MAR04FT-1) 1/5 Module 2 – Case ACQUIRING AND RETAINING

3/25/24, 5:11 PM Case – MGT407 Principles of Human Resource Management (2024MAR04FT-1) 1/5 Module 2 – Case ACQUIRING AND RETAINING TALENT Signature Assignment: Information Literacy, Introduced level In this assignment, your information literacy skills will be assessed at the “introduced” level. The information literacy rubric will be useful for this

3/25/24, 5:12 PM SLP – MGT407 Principles of Human Resource Management (2024MAR04FT-1) 1/4 Module 2 – SLP ACQUIRING AND RETAINING

3/25/24, 5:12 PM SLP – MGT407 Principles of Human Resource Management (2024MAR04FT-1) 1/4 Module 2 – SLP ACQUIRING AND RETAINING TALENT Overview Signature Assignment: Written Communication, Reinforced level In this assignment, your written communications skills will be assessed. The written communications rubric will be useful for this purpose. In the