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RegisterContracted Phase 1 Trial QA & Compliance [GxP / QC / QA]
Hi Debbie
you are right, there is no recommendation whether the trail related original documents should be kept with trail site (CRO) or the sponsor. This should be clarified in an agreement. Usually the original essential documents are kept with the trial site since also some documents which should not be forwarded to the sponsor (e.g. Subject Identification Log) are kept there together with internal (not essential but original) documents (staff, timetables, certificates) which might become important during an inspection. I know that some sponsor like to have the original documentation but I see no need for that.
I hope this helps.
Kind regards
Dan
you are right, there is no recommendation whether the trail related original documents should be kept with trail site (CRO) or the sponsor. This should be clarified in an agreement. Usually the original essential documents are kept with the trial site since also some documents which should not be forwarded to the sponsor (e.g. Subject Identification Log) are kept there together with internal (not essential but original) documents (staff, timetables, certificates) which might become important during an inspection. I know that some sponsor like to have the original documentation but I see no need for that.
I hope this helps.
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 & 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 & ComplianceDr_Dan 2010-06-02 11:33
- Contracted Phase 1 Trial QA & Compliance Debbie 2010-05-30 18:37
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