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RegisterRequirement of temperature data before dosing [Study Performance]
Dear Ohlbe,
Thanks for reply.
I would like to inform that sponsor is not going to give stabiity data to CRO.
My point is whether we can dose the subject if we do not have temperature data from dispatch of IP from Sponsor's manufacturing site to CRO.
Whether it is an safety issue for subject?
Thanks for reply.
I would like to inform that sponsor is not going to give stabiity data to CRO.
My point is whether we can dose the subject if we do not have temperature data from dispatch of IP from Sponsor's manufacturing site to CRO.
Whether it is an safety issue for subject?
Complete thread:
- Requirement of temperature data before dosing anky1212 2017-07-20 08:08
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Requirement of temperature data before dosing Ohlbe 2017-07-20 09:57
- Requirement of temperature data before dosinganky1212 2017-07-20 10:21
- Requirement of temperature data before dosing Ohlbe 2017-07-20 10:24
- Requirement of temperature data before dosing anky1212 2017-07-20 11:33
- Requirement of temperature data before dosing ElMaestro 2017-07-20 12:13
- Requirement of temperature data before dosing anky1212 2017-07-20 11:33
- Requirement of temperature data before dosing Ohlbe 2017-07-20 10:24
- Requirement of temperature data before dosinganky1212 2017-07-20 10:21
- Requirement of temperature data before dosing Ohlbe 2017-07-20 09:57
Ing. Helmut Schütz