eBook - ePub
The Duty for Sponor Oversight in Clinical Trials
Practical Guide: 2nd Edition Clinical Data Review
- 75 pages
- English
- ePUB (mobile friendly)
- Available on iOS & Android
eBook - ePub
The Duty for Sponor Oversight in Clinical Trials
Practical Guide: 2nd Edition Clinical Data Review
About this book
The first edition of the practical guide related to the topic The Duty for Sponsor Oversight in Clinical Research outlined the underlying requirements as well as possible approaches to implement it efficiently in small and mid-sized companies. This was based on a master's thesis released in April 2019. The next edition will focus on the Clinical Data Review which includes all aspects to be considered, for example, the outcome of the overall monitoring oversight activities. Furthermore, to describe and show examples of a standardized score assignment to ensure a unique process of the assessment.
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Please note we cannot support devices running on iOS 13 and Android 7 or earlier. Learn more about using the app.
Yes, you can access The Duty for Sponor Oversight in Clinical Trials by Doris Breiner in PDF and/or ePUB format, as well as other popular books in Biological Sciences & Science General. We have over one million books available in our catalogue for you to explore.
Information
Table of contents
- The Duty for Sponor Oversight in Clinical Trials
- Preamble
- Table of Content
- 1. Introduction
- 2. Underlying Rationale and Assumptions to the Approach
- 3. Definition of the Clinical Data Review
- 4. Clinical Data Review Details
- 5. Risk Score Calculation
- 6. Safety Management and Reporting Review as well as Clinical Data Coding Review (ICH-GCP 5.16, 5.17)
- 7. Quality Control
- 8. Sponsor Oversight Plan – Cross References
- 9. Conclusion
- References
- List of Tables
- Abbreviations
- Copyright