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)
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Criteria
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Ratings
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Pts
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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.
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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.
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13 pts
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This criterion is linked to a Learning OutcomeCTD Format
CTD Module aligns with table of contents
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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
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15 pts
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This criterion is linked to a Learning OutcomeSummary Content
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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
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25 pts
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Total Points: 53
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