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RegisterDose escalation and DMC [Design Issues]
posted by Helmut 
– Vienna, Austria, 2020-01-07 11:18 – Posting: # 21064
Views: 944
Hi Pharma_88,
I agree with what Ohlbe wrote.
Note that the decision on whether or not to proceed to the next cohort must not be done at the clincal site but by an external Data Monitoring Committee (DMC). See also the EMA’s Guideline.
I agree with what Ohlbe wrote.
Note that the decision on whether or not to proceed to the next cohort must not be done at the clincal site but by an external Data Monitoring Committee (DMC). See also the EMA’s Guideline.
—
Cheers,
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Cheers,
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- 3+3 Design Pharma_88 2020-01-07 08:09 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 3+3 Design Ohlbe 2020-01-07 11:25
- 3+3 Design Pharma_88 2020-01-08 09:55
- Subject replacement Ohlbe 2020-01-08 10:41
- 3+3 Design Pharma_88 2020-01-08 09:55
- Dose escalation and DMCHelmut 2020-01-07 12:18
- Dose escalation and DMC Pharma_88 2020-01-08 09:56
- 3+3 Design Ohlbe 2020-01-07 11:25
Ing. Helmut Schütz