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Language:
English
Total Size:
1.3 GB
Info Hash:
CA35D3B5998211AFDFCBCD8E1A182555E32AC4EC
Added By:
Added:
Jan. 1, 2024, 5:15 p.m.
Stats:
|
(Last updated: May 6, 2025, 7:09 p.m.)
| File | Size |
|---|---|
| Get Bonus Downloads Here.url | 182 bytes |
| 1. Welcome.mp4 | 14.3 MB |
| 2. Breaking Down the Myths.mp4 | 35.4 MB |
| 3. Course Objectives and Content.mp4 | 5.7 MB |
| 1. Daily Life as a Regulatory Medical Writer.mp4 | 16.8 MB |
| 2. Staying Up to Date as a Medical Writer and Final Tips for Success.mp4 | 12.0 MB |
| 1. The Who, What, Where, When, and Why of Medical Writing.mp4 | 31.2 MB |
| 1. Guidances, Templates, and Style Guides.mp4 | 23.6 MB |
| 1.1 ICH E3.pdf | 249.7 KB |
| 1.2 ICH E6.pdf | 689.3 KB |
| 1.3 M4.pdf | 261.8 KB |
| 1.4 M4E(R2).pdf | 470.3 KB |
| 1.5 M4S.pdf | 115.5 KB |
| 2. Walk-Through of ICH E6 Guidance.mp4 | 82.8 MB |
| 3. The Value of Templates in Medical Writing.mp4 | 26.7 MB |
| 4. Walk-Through of the Transcelerate Protocol Template (Contents of a Template).mp4 | 71.5 MB |
| 4.1 CPT_CoreBWE-v009.docx | 305.9 KB |
| 5. Style Guides The Medical Writer's Go-To Resource.mp4 | 12.9 MB |
| 6. Other Software and Tools for Success.mp4 | 31.3 MB |
| 1. Steps for Developing a Regulatory Document - Part 1.mp4 | 22.2 MB |
| 2. Steps for Developing a Regulatory Document - Part 2.mp4 | 55.9 MB |
| 3. Walk-Through of Example Timeline.mp4 | 38.7 MB |
| 1. Writing Effective Regulatory Documents.mp4 | 25.1 MB |
| 2. Working Collaboratively to Develop Documents.mp4 | 22.2 MB |
| 3. Tips for Moving Documents Through the Development Process.mp4 | 40.8 MB |
| 3.1 Example document review notification email.pdf | 134.4 KB |
| 4. Challenges in Medical Writing.mp4 | 40.6 MB |
| 5. How Medical Writers Add Value to Their Teams.mp4 | 15.8 MB |
| 1. Types of Regulatory Documents and the Common Technical Document (CTD).mp4 | 38.1 MB |
| 2. Regulatory Submissions and Applications.mp4 | 45.2 MB |
| 3. Content of the CTD - Part 1.mp4 | 11.9 MB |
| 4. Content of the CTD - Part 2.mp4 | 10.9 MB |
| 5. Content of the CTD - Part 3.mp4 | 25.5 MB |
| 6. Clinical Trial Documents and Other Regulatory Documentation.mp4 | 17.9 MB |
| 1. What is a Clinical Trial Protocol.mp4 | 29.0 MB |
| 2. Clinical Trial Design.mp4 | 16.2 MB |
| 3. Controls and Bias Elimination.mp4 | 20.4 MB |
| 4. Objectives, Endpoints, Population, and Assessments.mp4 | 31.0 MB |
| 5. Process for Protocol Development.mp4 | 20.5 MB |
| 6. Walk-Through of the Transcelerate Protocol Template (Sections of a Protocol).mp4 | 223.9 MB |
| 7. Protocol Tips and When to Amend.mp4 | 16.2 MB |
| 1. What is an Investigator's Brochure (IB).mp4 | 12.6 MB |
| 2. Content of an IB - Sections 1 through 5.mp4 | 28.3 MB |
| 3. Content of an IB - Sections 6 and 7.mp4 | 17.9 MB |
| 4. IB Tips and When to Update.mp4 | 16.2 MB |
| 1. What is a Clinical Study Report (CSR).mp4 | 21.8 MB |
| 1.1 CSR_CoreBWE-v004.docx | 142.1 KB |
| 2. Non-Data vs Data Sections of a CSR.mp4 | 19.2 MB |
| 3. Other Components of a CSR Safety Narratives, CSR Synopsis, and Appendices.mp4 | 24.6 MB |
| 4. CSR Tips and Types.mp4 | 22.2 MB |
| Bonus Resources.txt | 386 bytes |
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SOURCE: Regulatory Medical Writing Basics DevCourseWeb
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