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
Leave a Reply
Want to join the discussion?Feel free to contribute!