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RegisterContracted Phase 1 Trial QA & Compliance [GxP / QC / QA]
Dear raghavendra
You said that after completion of the trial all the documents were sent to the sponsor. I think you sent copies but kept the originals, right? According to CMP/ICH/135/95 you have to keep the essential documents at your side and for this you should follow your SOPs.
Kind regards
Dan
You said that after completion of the trial all the documents were sent to the sponsor. I think you sent copies but kept the originals, right? According to CMP/ICH/135/95 you have to keep the essential documents at your side and for this you should follow your SOPs.
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Contracted Phase 1 Trial QA & Compliance raghavendra_s 2010-04-29 11:29
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Contracted Phase 1 Trial QA & ComplianceDr_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
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