Data monitoring in clinical trials : : a practical perspective / / Susan S. Ellenberg, Thomas R. Fleming, David I. DeMets.
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| Superior document: | Statistics in practice |
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| VerfasserIn: | |
| TeilnehmendeR: | |
| Place / Publishing House: | Hoboken, NJ : : Wiley,, 2019. |
| Year of Publication: | 2019 |
| Edition: | Second edition. |
| Language: | English |
| Series: | Statistics in practice.
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| Online Access: | |
| Physical Description: | 1 online resource (493 pages). |
| Notes: | Preceded by Data monitoring in committees in clinical trials : a practical perspective / Susan S. Ellenberg, Thomas R. Fleming, David L. DeMets. 2002. |
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Table of Contents:
- Responsibilities of the data monitoring committee and motivating illustrations
- Composition of a data monitoring committee
- Independence of the data monitoring committee : avoiding conflicts of interest
- Confidentiality issues relating to the data monitoring committee
- Data monitoring committee meetings
- Data monitoring committee interactions with other trial components or related groups
- Statistical, philosophical and ethical issues in data monitoring
- Determining when a data monitoring committee is needed
- Regulatory considerations for the operation of data monitoring committees
- Legal considerations for DMCs.