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RegisterRetention of testing sample [Regulatives / Guidelines]
Dear all,
After completion of clinical trial, could we send the retention samples from trial site back to CRO who conduct project management, bioanalysis, PK/statistical analysis and issue final report? And could we retain the reserve samples in CRO?
According to FDA guideline, the reserve samples should not send back to the study sponsor or drug manufacturer. Could we look on the CRO as a independent third party?
Best Regards,
Grace
After completion of clinical trial, could we send the retention samples from trial site back to CRO who conduct project management, bioanalysis, PK/statistical analysis and issue final report? And could we retain the reserve samples in CRO?
According to FDA guideline, the reserve samples should not send back to the study sponsor or drug manufacturer. Could we look on the CRO as a independent third party?
Best Regards,
Grace
Complete thread:
- Retention of testing samplegracehung 2014-02-11 11:44
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Ing. Helmut Schütz