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RegisterContracted Phase 1 Trial QA & Compliance [GxP / QC / QA]
Dear Madam/Sir,
A sponsor contracted a Phase 1 trial to the CRO, CRO conducted the trial and followed their own SOP's in all the aspects including the TMF also, after completion of the trial all the documents sent to the sponsor, here my question is according to whose SOP these documents should maintain. What happens, if any regulatory body audits the CRO for this study.
Thanks and regards,
A sponsor contracted a Phase 1 trial to the CRO, CRO conducted the trial and followed their own SOP's in all the aspects including the TMF also, after completion of the trial all the documents sent to the sponsor, here my question is according to whose SOP these documents should maintain. What happens, if any regulatory body audits the CRO for this study.
Thanks and regards,
Complete thread:
- Contracted Phase 1 Trial QA & Complianceraghavendra_s 2010-04-29 11:29
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Contracted Phase 1 Trial QA & Compliance Dr_Dan 2010-04-29 12:14
- Contracted Phase 1 Trial QA & Compliance Ohlbe 2010-04-29 12:14
- Contracted Phase 1 Trial QA & Compliance raghu 2010-04-29 18:23
- Contracted Phase 1 Trial QA & Compliance Debbie 2010-05-30 18:37
- Contracted Phase 1 Trial QA & Compliance Dr_Dan 2010-06-02 11:33
- Contracted Phase 1 Trial QA & Compliance Debbie 2010-05-30 18:37
Ing. Helmut Schütz