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RegisterSubject selected into study with BMI not as per protocol [Study Performance]
Dear John,
This would not be acceptable for studies for EU submission. See the Q&A published by EMA's GCP inspectors working group. The protocol is not just something between the sponsor and the investigator: it is also approved by the IEC / IRB, and depending on the local regulations, by the regulatory authorities.
❝ Did you get sponsor's approval to allow those subjects to be enrolled into the study? I placed some studies in the past and have encountered this. The CRO would inform me, ask me to decide and sign a note to file.
This would not be acceptable for studies for EU submission. See the Q&A published by EMA's GCP inspectors working group. The protocol is not just something between the sponsor and the investigator: it is also approved by the IEC / IRB, and depending on the local regulations, by the regulatory authorities.
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Subject selected into study with BMI not as per protocol vivekanand 2013-04-29 14:35 [Study Performance]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Subject selected into study with BMI not as per protocol jag009 2013-04-29 15:17
- Subject selected into study with BMI not as per protocolOhlbe 2013-04-29 16:45
- Protocol deviation Helmut 2013-04-29 15:20
- Protocol deviation Dr_Dan 2013-04-29 16:54
- Protocol deviation Helmut 2013-04-29 17:26
- Protocol deviation Dr_Dan 2013-04-29 16:54
- Subject selected into study with BMI not as per protocol sarada06884 2013-04-30 12:34
- Subject selected into study with BMI not as per protocol jag009 2013-04-29 15:17
Ing. Helmut Schütz