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RegisterContracted Phase 1 Trial QA & Compliance [GxP / QC / QA]
Hi,
is it compulsory that the original documents shall be retained by the trail sit (CRO)?
If, the sponsor has asked to provide the original documents and asked the CRO to retain the copy of the documents.
as per Dr. Dan's comments in the above post, as per CMP/ICH/135/95, i could not find any statement saying that the trail site(CRO) must retain the original documents.
instead, as per the ICH-E6 GCP guidance (page no 50), the original copy of the CRF shall be maintained by the sponsor and a copy shall be retained with the investigator/institution.
please comment whetther the trail related original documents should be kept with trail site (CRO) or the sponsor.
Regards,
is it compulsory that the original documents shall be retained by the trail sit (CRO)?
If, the sponsor has asked to provide the original documents and asked the CRO to retain the copy of the documents.
as per Dr. Dan's comments in the above post, as per CMP/ICH/135/95, i could not find any statement saying that the trail site(CRO) must retain the original documents.
instead, as per the ICH-E6 GCP guidance (page no 50), the original copy of the CRF shall be maintained by the sponsor and a copy shall be retained with the investigator/institution.
please comment whetther the trail related original documents should be kept with trail site (CRO) or the sponsor.
Regards,
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 & ComplianceDebbie 2010-05-30 18:37
- Contracted Phase 1 Trial QA & Compliance Dr_Dan 2010-06-02 11:33
- Contracted Phase 1 Trial QA & ComplianceDebbie 2010-05-30 18:37
Ing. Helmut Schütz