Entries by James

Module 6 CTD Assignment HCR577

Module 6 CTD Assignment HCR577 Module 6: Comprehensive CTD Due Apr 24 by 11:59pm Points 50 Submitting a text entry box, a website url, a media recording, or a file upload Available Mar 16 at 12am – May 1 at 11:59pm Combine your CTD.  Include the table of contents and each module in order for a complete submission. Create a cover […]

Course Reflection Assignment HCR 577

Course Reflection Assignment HCR 577 Due Monday by 11:59pm Points 100 Submitting a text entry box Available Mar 30 at 12am – Apr 29 at 11:59pm What is Reflective Writing? It is: A way of thinking to explore your learning and to express your views. An opportunity to gain self-knowledge, deepen your thought and understanding A careful consideration of what you […]

HCR 577 Course Reflection

HCR 577 Course Reflection Due Monday by 11:59pm 4/27/2026 Points 100 Submitting a text entry box Available Mar 30 at 12am – Apr 29 at 11:59pm What is Reflective Writing? It is: A way of thinking to explore your learning and to express your views. An opportunity to gain self-knowledge, deepen your thought and understanding A careful consideration of what you […]

HCR 577-Final Exam

HCR 577-Final Exam Points 125   Questions 5   Available Apr 10 at 12am – May 2 at 11:59pm   Time Limit None Instructions The final exam consists of five (5) Essay Questions. In you answer for each question provide 3 paragraphs (4-5 sentences) to answer the question topic. Include at least 3 references for each question. Each question […]

HCR 577 Module 5: CTD Modules 4 and 5

HCR 577 Module 5: CTD Modules 4 and 5 Due Wednesday by 11:59pm- 4/15/2026   Points 50   Submitting a file upload   Available Mar 18 at 12am – May 1 at 11:59pm Complete CTD – Modules 4: Nonclinical/technical requirements & 5: Clinical Studies & Reports; Benefit-Risk Information. Refer to Module 2 References in the Learning Materials Folder for specific instructions […]

HCR577Discussion Post Module 5

HCR577Discussion Post Module 5 Discussion Topic: Module 5: Discussion PostModule 5: Discussion Post Instructions Benefit Risk The discussion this week is a bit different that previous discussions. This discussion has three (3) parts. These include (1) Identifying/listing 3 benefit risk dimensions and then discuss benefit risk. (2) For your Peer review, choose two dimensions identified […]

Applied Project Reflection Assignment- HCR 593

Applied Project Reflection Assignment- HCR 593 Module 10: Applied Project Reflection (100 pts) Due Sunday by 11:59pm Points 100 Submitting a text entry box or a file upload Available until Apr 16 at 11:59pm Applied Project Reflection Instructions The Applied Project is the culmination of the Regulatory Science Program. In this course, you applied the concepts learned throughout the program to a […]

HCR 593 Final AP submission

HCR 593 Final AP submission Module 11: HCR 593 Final Applied Project Submission (250 pts)*** THIS IS IT!! 🙂 Due Apr 19 by 11:59pm Points 250 Submitting a text entry box or a file upload File Types doc and docx If you have made it to this page and are ready to submit your project, CONGRATULATIONS for making it to the […]

HCR 577 Summary Group 4 Project 2

HCR 577 Summary Group 4 Project 2 Summary Module 5: Group Assignment: Project Management Steps to Ensure a Successful Submission Due Thursday by 11:59pm Points 100 Submitting a file upload Available Mar 18 at 12am – Apr 17 at 11:59pm Your team (same groups as the country presentation) is responsible for the project management of the submission your company’s NDA to FDA. […]

HCR 577 CTD module 4&5 Assignment

HCR 577 CTD module 4&5 Assignment Module 5: CTD Modules 4 and 5 – due date Wednesday 15/2026 Due Wednesday by 11:59pm Points 50 Submitting a file upload Available Mar 18 at 12am – May 1 at 11:59pm Complete CTD – Modules 4: Nonclinical/technical requirements & 5: Clinical Studies & Reports; Benefit-Risk Information. Refer to Module 2 References in the Learning Materials […]