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RegisterEvidences for GCP [GxP / QC / QA]
Dear all
We have conducted BE Study in India through a CRO and submitted the report to one regulatory authority. But regulatory authority has asked to provide evidences that the study has been conducted following Good Clinical Practices. Could you please tell us what evidences we can ask from our CRO regarding GCP?
Would appreciate your kind response.
Sincerely
Jasim Uddin
Edit: Category changed. [Helmut]
We have conducted BE Study in India through a CRO and submitted the report to one regulatory authority. But regulatory authority has asked to provide evidences that the study has been conducted following Good Clinical Practices. Could you please tell us what evidences we can ask from our CRO regarding GCP?
Would appreciate your kind response.
Sincerely
Jasim Uddin
Edit: Category changed. [Helmut]
Complete thread:
- Evidences for GCPJasim Uddin 2012-08-23 20:52 [GxP / QC / QA]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Evidences for GCP Debbie 2012-08-24 16:53
- Evidence? Helmut 2012-08-24 19:28
- Evidence? Jasim Uddin 2012-09-04 12:06
Ing. Helmut Schütz