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 letter is to accompany this submission to FDA.  You are the company representative as a regulatory professional so you will sign this letter.  Please also include the label.  Submission includes CTD Module 1, 2, 3, 4, & 5.
Rubric
CTD Module (2)
Criteria
Ratings
Pts
This criterion is linked to a Learning OutcomeTable of Contents Updated
For each CTD Module provide an updated table of contents to reflect the sections of the CTD.
15 ptsExcellentCompletes all sections of the CTD Module 1, 2, 3, 4, & 5 as instructed.
13 ptsGoodCompletes CTD Module 1, 2, 3, 4, & 5 with only one error or one incomplete line.
0 ptsNeeds ImprovementCTD Module 1, 2, 3, 4, & 5 is incomplete without explanation.
15 pts
This criterion is linked to a Learning OutcomeCTD Format
CTD Module aligns with table of contents
15 ptsExcellentFollows CTD Module 1, 2, 3, 4, & 5 format, spelling and grammar correct with no more than 2 errors.
10 ptsGoodFollows CTD Module 1, 2, 3, 4, & 5 format, spelling and grammar appropriate with no more than 3 – 5 errors.
0 ptsPoorDoes not follow CTD Module 1, 2, 3, 4, & 5 format
15 pts
This criterion is linked to a Learning OutcomeSummary Content
20 ptsExcellentProvides studies and product information under appropriate headings
12 ptsGoodSome studies and product information are not under appropriate headings
0 ptsPoorDoes not provides studies and product information under appropriate headings
20 pts
Total Points: 50

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 have learned
  • A way to achieve clarity and a better understanding of what you are learning; look at your experience in order to analyze and learn from what took place
  • A way of making meaning out of what you study
It is not:
  • Just conveying information
  • Pure description
  • Straight forward decision or judgment
  • Simple problem solving
  • A summary of course notes
  • A standard university essay
Questions to Explore
  • What did you learn from this course? About yourself? About working in the field?
  • Did your experience fit with the listed outcomes of the course? Why or why not? What was successful? Why? What would you do differently? Why?
Characteristics of Reflection Essays
  • It is purposeful – not just jotting down notes or thoughts.
  • It is personal – it explores the relationship between the writer and what was learned
  • It is perceptive and includes:
    • Analysis – what are the causes and effects of learning
    • Synthesis – how do the components relate to each other? What have you learned?
    • Evaluation – your attitude towards the subject. How have you been affected?
  • It is polished – although it does not use research sources, reflective writing must meet standards of precision, clarity, conciseness, and correctness of any other style of formal writing.
Reflection Essays – Expectations
  • Critically engage with concepts from your course by making connections between your observations, experiences and opinions.
  • Explain and analyze these concepts from your point of view using original ideas.
Drafting Your Reflection
  • Think about it.
  • Explore the significance.
  • Organize your reflection. Start with an account of what you have learned and explain its significance.
  • Elaborate on your ideas. Use precise, vivid language to convey what you learned.
  • Avoid clichés.
  • Edit and proofread.
  • Read the reflection back to yourself aloud. Check for clear organization and graceful transitions.
  • Run a spell check.
Rubric Points for Reflection Assignment
  • Be written if first person.
  • Describe the significance of what you learned in the course.
  • Use figurative language, dialogue or other techniques to recreate the experience for the reader.
  • Make observation(s) about your career/work experience based on what you learned.
  • Address the points listed in the course reflection.
  • Organized, concise, clear and meets standards of formal writing.
Please add your course reflection to your digital portfolio. Provide a link to you portfolio and the reflection to the course instructor as well as submitting your reflection here.
Rubric
Reflection Rubric for CRM courses
Criteria
Ratings
Pts
This criterion is linked to a Learning OutcomeWritten in 1st person and includes personal observations
5 ptsNoviceLittle or no use of 1st person point of view. Does not tie observation to course concepts.
15 ptsCompetentMostly written in 1st person point of view. Is able to ties most of observations to course concepts. Provides general analysis of what was learned.
25 ptsProficientReflection observations are written from 1st person point of view. Clearly ties concepts from the course to observations about what was learned. Clearly explains and analyzes what was learned.
25 pts
This criterion is linked to a Learning OutcomeSignificance
5 ptsNoviceExplanation of significance is vague, little thought given to significance. Does not apply original thought or reflect on the impact of job, industry, or career plans.
15 ptsCompetentDescribes and explains significance of what was learned in the course. Includes original thoughts and ideas. Generally reflects on the impact of what was learned on industry is general.
25 ptsProficientDescribes and explains significance of what was learned in the course. Includes original thoughts and ideas. Reflects on the impact of what was learned on own job or career plans.
25 pts
This criterion is linked to a Learning OutcomeAddress Reflection Points
5 ptsNoviceReflection mentions, but does not address the points of assignment.
15 ptsCompetentReflection addresses most of the points in a general manner. Includes at least one personal observation and experience.
25 ptsProficientReflection addresses the points outlined in the reflection assignment, providing personal observations and experiences.
25 pts
This criterion is linked to a Learning OutcomeOrganization & Language
5 ptsNoviceWriting is not well organized, does not provide transitions and does not follow formal writing standards.
15 ptsCompetentReflection conveys to writer’s experience and is generally organized. Follows writing standards with few mistakes
25 ptsProficientReflection clearly conveys the writer’s experience. It is concise, organized and transitions smoothly using appropriate headings. Follows the standards of formal writing including grammar and spelling. Language used in reflection allows the reader to experience the writer’s experience.
25 pts
Total Points: 100

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 have learned
  • A way to achieve clarity and a better understanding of what you are learning; look at your experience in order to analyze and learn from what took place
  • A way of making meaning out of what you study
It is not:
  • Just conveying information
  • Pure description
  • Straight forward decision or judgment
  • Simple problem solving
  • A summary of course notes
  • A standard university essay
Questions to Explore
  • What did you learn from this course? About yourself? About working in the field?
  • Did your experience fit with the listed outcomes of the course? Why or why not? What was successful? Why? What would you do differently? Why?
Characteristics of Reflection Essays
  • It is purposeful – not just jotting down notes or thoughts.
  • It is personal – it explores the relationship between the writer and what was learned
  • It is perceptive and includes:
    • Analysis – what are the causes and effects of learning
    • Synthesis – how do the components relate to each other? What have you learned?
    • Evaluation – your attitude towards the subject. How have you been affected?
  • It is polished – although it does not use research sources, reflective writing must meet standards of precision, clarity, conciseness, and correctness of any other style of formal writing.
Reflection Essays – Expectations
  • Critically engage with concepts from your course by making connections between your observations, experiences and opinions.
  • Explain and analyze these concepts from your point of view using original ideas.
Drafting Your Reflection
  • Think about it.
  • Explore the significance.
  • Organize your reflection. Start with an account of what you have learned and explain its significance.
  • Elaborate on your ideas. Use precise, vivid language to convey what you learned.
  • Avoid clichés.
  • Edit and proofread.
  • Read the reflection back to yourself aloud. Check for clear organization and graceful transitions.
  • Run a spell check.
Rubric Points for Reflection Assignment
  • Be written if first person.
  • Describe the significance of what you learned in the course.
  • Use figurative language, dialogue or other techniques to recreate the experience for the reader.
  • Make observation(s) about your career/work experience based on what you learned.
  • Address the points listed in the course reflection.
  • Organized, concise, clear and meets standards of formal writing.
Please add your course reflection to your digital portfolio. Provide a link to you portfolio and the reflection to the course instructor as well as submitting your reflection here.
Rubric
Reflection Rubric for CRM courses
Criteria
Ratings
Pts
This criterion is linked to a Learning OutcomeWritten in 1st person and includes personal observations
5 ptsNoviceLittle or no use of 1st person point of view. Does not tie observation to course concepts.
15 ptsCompetentMostly written in 1st person point of view. Is able to ties most of observations to course concepts. Provides general analysis of what was learned.
25 ptsProficientReflection observations are written from 1st person point of view. Clearly ties concepts from the course to observations about what was learned. Clearly explains and analyzes what was learned.
25 pts
This criterion is linked to a Learning OutcomeSignificance
5 ptsNoviceExplanation of significance is vague, little thought given to significance. Does not apply original thought or reflect on the impact of job, industry, or career plans.
15 ptsCompetentDescribes and explains significance of what was learned in the course. Includes original thoughts and ideas. Generally reflects on the impact of what was learned on industry is general.
25 ptsProficientDescribes and explains significance of what was learned in the course. Includes original thoughts and ideas. Reflects on the impact of what was learned on own job or career plans.
25 pts
This criterion is linked to a Learning OutcomeAddress Reflection Points
5 ptsNoviceReflection mentions, but does not address the points of assignment.
15 ptsCompetentReflection addresses most of the points in a general manner. Includes at least one personal observation and experience.
25 ptsProficientReflection addresses the points outlined in the reflection assignment, providing personal observations and experiences.
25 pts
This criterion is linked to a Learning OutcomeOrganization & Language
5 ptsNoviceWriting is not well organized, does not provide transitions and does not follow formal writing standards.
15 ptsCompetentReflection conveys to writer’s experience and is generally organized. Follows writing standards with few mistakes
25 ptsProficientReflection clearly conveys the writer’s experience. It is concise, organized and transitions smoothly using appropriate headings. Follows the standards of formal writing including grammar and spelling. Language used in reflection allows the reader to experience the writer’s experience.
25 pts
Total Points: 100

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 is worth 25 points each for a total of 125 points.
 
HCR577 Final Exam due
Started: Apr 12 at 12:03pm
Quiz 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 is worth 25 points each for a total of 125 points.
Question 125 pts
1-Discuss the impact of increased prescription drug costs.
2-Discuss 3D printing drugs.
3-Discuss that mergers and acquisitions continued   increase in the pharmaceutical industry.
4-What are combination products?
5-What the key considerations in preparing a clinical trial budget? (Module 4 Learning Materials, How to prepare a budget)

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 and requirements for the CTD.  Your submission will include Module 2, 3, 4 & 5.

The Comprehensive Table of Contents Headings and Hierarchy-2.pdf

CTD_Student_Guide_Assignment_Module 4 & 5.pdf

CTD_Student_Guide_Assignment_Module 4 & 5.docx

Rubric

CTD Module (3)

Criteria Ratings Pts
This criterion is linked to a Learning OutcomeTable of Contents Updated

For each CTD Module provide an updated table of contents to reflect the sections of the CTD.

13 ptsExcellentCompletes all sections of the CTD Module 2, 3, 4, & 5 correctly.

8 ptsGoodCompletes CTD Module 2, 3, 4, & 5 with only one error or one incomplete line.

0 ptsNeeds ImprovementCTD Module 2, 3, 4, & 5 is incomplete without explanation.

13 pts
This criterion is linked to a Learning OutcomeCTD Format

CTD Module aligns with table of contents

15 ptsExcellentFollows CTD Module 2, 3, 4, & 5 format, spelling and grammar correct with no more than 2 errors.

10 ptsGoodFollows CTD Module 2, 3, 4, & 5 format, spelling and grammar appropriate with no more than 3 – 5 errors.

0 ptsPoorDoes not follow CTD Module 2, 3, 4, & 5 format

15 pts
This criterion is linked to a Learning OutcomeSummary Content 25 ptsExcellentProvides studies and product information under appropriate headings

15 ptsGoodSome studies and product information are not under appropriate headings

0 ptsPoorDoes not provides studies and product information under appropriate headings

25 pts

Total Points: 53

PLACE YOUR ORDER NOW

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 by fellow students and discuss them. (3) And responding to at least 2 peer posts.
Initial Post
Part 1
List 3 Benefit Risk Dimensions. (10 points).
Discuss benefit risk,  discussion should be 3 paragraphs, with each paragraph being at least 4-5 sentences in length. (10 points).
Due on Wednesday at 11:59pm.
Peer Responses
Part 2: Review 2 (two) peer post and select two (2) Benefit Risk Dimensions from this student’s post and briefly discuss these 2 dimensions. (20 points)
Due on Sunday at 11:59pm.
Grading
Total points possible = 40.
See the grading rubric for a better understanding of how to get your best grade.  To access the rubric, click on the three vertical lines at the top of the page and select “show rubric.”
View the discussion rubric
Click on Reply to post to the discussion.
Module 5 Discussion Rubric (1)
Criteria
Ratings
Pts
This criterion is linked to a Learning OutcomeInitial Post
20 ptsExcellentThe post is comprehensive and fully answers the discussion prompt. Student used complete sentences, appropriate tone, and clear language.
10 ptsGoodThe post is comprehensive, but does not fully answer the discussion prompt. Student used complete sentences, appropriate tone, and mostly clear language.
0 ptsNeeds Significant ImprovementThe posting is not comprehensive and does not answer the discussion prompt. Student used Incomplete sentences, inappropriate tone, and/or unclear language.
20 pts
This criterion is linked to a Learning OutcomeReply Post
20 ptsExcellentStudent posted at least 1 reply to another student that was relevant to the discussion.
10 ptsGoodStudent posted one reply to another student, but it was not relevant or did not significantly contribute to the discussion.
0 ptsNeeds Significant ImprovementStudent did not post a reply, or reply contained incomplete sentences, inappropriate tone, and/ or unclear language.
20 pts
DISCUSSION MODULE 5 PART 2 & 3
Module 5 discussion board has been updated.  Part 3 was eliminated.  You are to post 2 peer responses related to benefit risk.
This topic is closed for comments.

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 final research project.  Your reflection of the projects should include some of the following points:
What we would like for you to do is to do an overall review of your project – how would you explain your topic to someone who is not in research?
  • Introduction: What is your project and why is it important to you? Basic literature review to support.
  • What is the main focus of the applied project?
  • Methodology: How did you approach your project? Any barriers to overcome?
  • Results/Outcomes: Discussion of your findings or what you created. Any future research? 
  • Do you find this claim to be clear? Interesting? Innovative?
  • What do you especially find compelling about doing your project?
  • What needs more explanation?
You are welcome to add tables/figures from your project, as well as paragraphs from the paper, to show off your work. Reflection should be in your own words, first person, with a maximum of 1,000 words (minimum of 450 words). Review guidelines and grading criteria: HCR 593 – Applied Project Reflective Writing.pdf

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 summit of this mountain! Take a moment to * take in the view *
Please submit your final Applied Project submission.
It will be reviewed by Turnitin for plagiarism, as with all other submissions. Review your Turnitin score and report carefully for any required updates. It is your responsibility to verify the authenticity of your work.
Maintain a copy of this project submission, all data you collected, and all consent forms (original), and follow all data privacy and safety requirements per your project and consent form details. As we know from clinical research requirements, if it wasn’t documented, it wasn’t done. See also ASU data integrity requirements: https://libguides.asu.edu/data . The department can, and often does, request access for verification if all other graduation requirements are met.
Make sure you check grammar, spelling, and verb tense. (Try Grammarly to support your efforts).
The final format must be in Word.doc/docx WITHOUT EXCEPTION. 
Applied Project – Final Paper
Criteria
Ratings
Pts
This criterion is linked to a Learning OutcomeTitle Page
Title Page is APA V.7. Creativity in title pages is not encouraged for a research project. Instead, use your creativity in graphs, figures and/or images in the paper to illuminate your points.
5 ptsFull Marks
0 ptsNo Marks
5 pts
This criterion is linked to a Learning OutcomeTable of Contents
Table of Contents include ALL of your five required sections and appendices. Add in any and all sub-headings used. If there is a graph or table in the results, it must be referenced correctly. See Module 10 page entitled Adding In Tables Graphs and Figures.
5 ptsFull Marks
0 ptsNo Marks
5 pts
This criterion is linked to a Learning OutcomeAbbreviations or Acronyms
Upon first introduction of an organization or phrase, acronyms and/or abbreviations are explained and consistently shortened as explained in the first iteration, throughout the document.
10 ptsFull Marks
0 ptsNo Marks
10 pts
This criterion is linked to a Learning OutcomeAbstract
Abstracts are generally kept brief (approximately 150-200 words). They differ by field, but in general, they need to summarize the article so that readers can decide if it is relevant to their work. The typical abstract includes these elements:

A statement of the problem and objectives
A statement of the significance of the work
A summary of employed methods or your research approach
A summary of findings or conclusions of the study
A description of the implications of the findings

20 ptsFull Marks
0 ptsNo Marks
20 pts
This criterion is linked to a Learning OutcomeChapter 1: Introduction
Include background, identify the gap, and add a rationale
30 ptsFull Marks
0 ptsNo Marks
30 pts
This criterion is linked to a Learning OutcomeAims / Objectives
The Objective of your applied project MUST be evident in the thesis statement, research questions, method, results and conclusion. Alignment is critical.
15 ptsFull Marks
0 ptsNo Marks
15 pts
This criterion is linked to a Learning OutcomeChapter 2: Review of Literature
30 ptsFull Marks
0 ptsNo Marks
30 pts
This criterion is linked to a Learning OutcomeChapter 3: Methods
1. Method is defined (if literature review, a seminal work is used to define what that means).
2. Method is clear. If you did a literature review, exactly how you did it, so it can be replicated, must be listed step by step. If you used a survey, which survey, who or how was it designed, what questions(APPENDIX), how did you pick your subjects to survey, include an Appendix of the consent form as well. What was the method used to deliver and receive the surveys?
Method used must be evident in the results collected. Method used most also be evident in the introduction where you outline the thesis. As such, Method must have alignment within your paper.
30 ptsFull Marks
0 ptsNo Marks
30 pts
This criterion is linked to a Learning OutcomeChapter 4: Results
Aligned with Thesis, research questions, method and conclusion. Results RESTATE the research question/s and shortly describe the method used to answer the questions. Results are clear (this cannot be stated strongly enough). Results are graphed or figured for clarity where possible. The entire scope of the project is evident in this section. For example, if 20 research articles were synthesized from the literature, the reader can clearly decipher what the student researcher found THEMATICALLY. If the results come from surveys, the summary of the survey findings is clearly listed so that any reader could understand the link between methods to the results.
20 ptsFull Marks
0 ptsNo Marks
20 pts
This criterion is linked to a Learning OutcomeChapter 5: Discussion
Discussion takes the results section and “discusses” them. Using the literature in your introductory literature review (or results if necessary), the student researcher, describes the most likely reason for the findings in the results section. If the results are in line with your assumptions (in the thesis) then STATE THAT OR ANY DIFFERENCE FROM YOUR THESIS. This is critical.
30 ptsFull Marks
0 ptsNo Marks
30 pts
This criterion is linked to a Learning OutcomeChapter 6: Conclusion
The conclusion discusses final takeaway points from the results and discussion, limitations of the research, future directions of similar research (important!) any unique findings or unusual findings.
30 ptsFull Marks
0 ptsNo Marks
30 pts
This criterion is linked to a Learning OutcomeReferences
All referenced articles/books/etc. are listed and associated accurately in citations throughout the paper. There is no material in your paper that is not original work other than the referenced material as listed.
References and citations are in APA style version 7.
one resource: 
https://owl.purdue.edu/owl/research_and_citation/resources.htmlLinksLinks to an external site.

one resource: https://owl.purdue.edu/owl/research_and_citation/resources.htmlLinksLinks to an external site.


Links to an external site. to an external site.
10 ptsFull Marks
0 ptsNo Marks
10 pts
This criterion is linked to a Learning OutcomeFormat: APA 7th edition format and Grammar
APA is more than referencing and citation. It is a method of writing. Be sure your paper has alignment between research questions, thesis statement, method, results, and conclusion. Verify that formatting is APA and grammar is correct. Papers should be 3-8 sentences per paragraph with flow from one paragraph to the other. New categories are identified with headings and subheadings. Sentences are active voice (not passive). Citations are correctly formatted. No running head but page numbers, margins and font are per APA.
15 ptsFull Marks
0 ptsNo Marks
15 pts
Total Points: 250

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. The market for your drug is highly competitive therefore meeting the timelines is critical. Prepare a timeline and assign roles and responsibilities to specific team members, as listed.
  • Quality Control
  • Validation Engineering
  • Formulation
  • Manufacturing
  • Regulatory
  • Quality Assurance
  • Facilities
  • Logistics
For Week 5, prepare a presentation to share with the development team. Show in the slides how this approach would be successful.
Provide 3-5 topics / questions where the FDA may request additional information and how you would manage this request.
Summary
Prepare a 1 page summary, ADA style, for your proposal to be submitted with your presentation. Submission to FDA: Dec 2027
Rubric
Group PowerPoint & Summary (1)
Criteria
Ratings
Pts
This criterion is linked to a Learning OutcomePowerPoint
50 ptsExcellentPowerPoint presentation has a cover sheet, 1 slide with recommendation, 3-4 slides discussion, 1 slide conclusion, 1 slide with references.
35 ptsGoodany 1 of these missing: PowerPoint presentation has a cover sheet, 1 slide with recommendation, 3-4 slides discussion, 1 slide conclusion, 1 slide with references.
15 ptsNeeds Improvement2 or more missing: PowerPoint presentation has a cover sheet, 1 slide with recommendation, 3-4 slides discussion, 1 slide conclusion, 1 slide with references.
50 pts
This criterion is linked to a Learning OutcomeSummary Format
20 ptsExcellentFollows APA format, spelling and grammar correct with no more than 2 errors.
10 ptsGoodFollows APA format, spelling and grammar appropriate with no more than 3 – 5 errors.
5 ptsPoorDoes not do or does not following instructions and does not meet requirements.
20 pts
This criterion is linked to a Learning OutcomeSummary Content
30 ptsExcellentProvides a detailed summary of product and supports with 3 or more references, one of which must be from the ASU library. Meets 1 page requirement.
15 ptsGoodGeneral description that covers points, includes at least 2 references, one must be from the ASU library. Meets 1 page requirement.
0 ptsPoorDoes not do or work turned in does not meet assignment requirements. Does not meet 1 page requirement, either too long or too short.
30 pts
Total Points: 100

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 Folder for specific instructions and requirements for the CTD.  Your submission will include Module 2, 3, 4 & 5.
Rubric
CTD Module (3)
Criteria
Ratings
Pts
This criterion is linked to a Learning OutcomeTable of Contents Updated
For each CTD Module provide an updated table of contents to reflect the sections of the CTD.
13 ptsExcellentCompletes all sections of the CTD Module 2, 3, 4, & 5 correctly.
8 ptsGoodCompletes CTD Module 2, 3, 4, & 5 with only one error or one incomplete line.
0 ptsNeeds ImprovementCTD Module 2, 3, 4, & 5 is incomplete without explanation.
13 pts
This criterion is linked to a Learning OutcomeCTD Format
CTD Module aligns with table of contents
15 ptsExcellentFollows CTD Module 2, 3, 4, & 5 format, spelling and grammar correct with no more than 2 errors.
10 ptsGoodFollows CTD Module 2, 3, 4, & 5 format, spelling and grammar appropriate with no more than 3 – 5 errors.
0 ptsPoorDoes not follow CTD Module 2, 3, 4, & 5 format
15 pts
This criterion is linked to a Learning OutcomeSummary Content
25 ptsExcellentProvides studies and product information under appropriate headings
15 ptsGoodSome studies and product information are not under appropriate headings
0 ptsPoorDoes not provides studies and product information under appropriate headings
25 pts
Total Points: 53