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RegisterRequirement of temperature data before dosing [Study Performance]
Hi All,
Please note following scenario,
Sponsor going to ship IP today but sponsor is not able to sent temperature data during shipment of product to CRO. Dispensing has been done without having temperature data during shipment. Tommorrow, there is dosing of subject.
Is it any concern for dispensing as well as dosing of subject even though temperature data during shipment not available?
Please provide your view on above scenario (along with guidance if available).
Please note following scenario,
Sponsor going to ship IP today but sponsor is not able to sent temperature data during shipment of product to CRO. Dispensing has been done without having temperature data during shipment. Tommorrow, there is dosing of subject.
Is it any concern for dispensing as well as dosing of subject even though temperature data during shipment not available?
Please provide your view on above scenario (along with guidance if available).
Complete thread:
- Requirement of temperature data before dosinganky1212 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 dosing anky1212 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 dosing anky1212 2017-07-20 10:21
- Requirement of temperature data before dosing Ohlbe 2017-07-20 09:57
Ing. Helmut Schütz