Module 3: CTD Module 2: Product Summary – HCR577
Module 3: CTD Module 2: Product Summary – HCR577
Module 3: CTD Module 2: Product Summary
- Due Thursday by 11:59pm- March 26
- Points 50
-
Submitting a file
-
Module 3: CTD Module 2: Product SummaryUsing the CTD scenario provided in Module 1/ Week 1 and your assigned drug, complete the Module 2 Quality Summary of the CTD. Refer to Module 2 References in the Learning Materials Folder for specific instructions and requirements for the CTD. Be sure to have a table of contents. Where you cannot find information on a given topic then write “not available”.This is a “copying” assignment. You will use your package insert and other reference material to complete the CTD. While the instructions may indicate that you write a paragraph it is simply indicating that you copy and paste a paragraph from your source materials.Additional guidance can be found in:
- Due Thursday by 11:59pm
- Points 50
- Submitting a file upload
-
Available Mar 18 at 12am – March 26 at 11:59pm
-
RubricCTD ModuleCriteriaRatingsPtsThis criterion is linked to a Learning OutcomeTable of Contents UpdatedFor each CTD Module provide an updated table of contents to reflect the sections of the CTD.10 ptsExcellentCompletes all sections of the CTD Module correctly.8 ptsGoodCompletes CTD Module with only one error or one incomplete line.0 ptsNeeds ImprovementCTD Module is incomplete without explanation.10 ptsThis criterion is linked to a Learning OutcomeCTD FormatCTD Module aligns with table of contents15 ptsExcellentFollows CTD format, spelling and grammar correct with no more than 2 errors.13 ptsGoodFollows CTD format, spelling and grammar appropriate with no more than 3 – 5 errors.0 ptsPoorDoes not follow CTD format15 ptsThis criterion is linked to a Learning OutcomeSummary Content25 ptsExcellentProvides studies and product information under appropriate headings15 ptsGoodSome studies and product information are not under appropriate headings10 ptsPoorDoes not provides studies and product information under appropriate headings25 ptsTotal Points: 50
Module 1: Overview of Common Technical Document (CTD) Assignments
CTD Module Preparation
In this class, you are preparing a submission for the FDA. You know that the FDA requires the submission in the Common Technical Document (CTD) format. This format is new to your company. You want to ensure that management has time to review and approve each section to prevent delays due to the need to address feedback and comments.
You will use ADA formatting for your CTD. Each Section must be completed with information received in class or by researching your assigned drug.Refer to the classroom materials and online guidelines and guidance for CTD formatting.
- During Module 1/Week 1, you will identify the drug for this CTD drug in the discussion.
- During Modules/Weeks 2,3,4 & 5, you will use your assigned drug to complete each of the Modules.
- For Module 4 & 5, research types of studies that may be performed during clinical studies. List at least 3-5 studies for these sections.
- In Module 6, finally you will assemble the CTD into a single document. Then, preparing for submission, you will prepare a 1 page cover letter to the health authority and add this to the CTD and submit to complete the assignment.
Leave a Reply
Want to join the discussion?Feel free to contribute!