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RegisterEvidences for GCP [GxP / QC / QA]
Hi Jasim,
You may ask the CRO to provide any certification (if they have any) stating the GCP compliance from any of the regulatory agency (may not be same agency to which you have submitted the study) and if no formal certification is available, you may ask for the list of audit reports and compliance reports for regulatory audits different regulatory audits conducted at that CRO indicating that procedures are established for regulatory compliance.
In addition, ask the principal investigator to give a declaration stating that GCP was followed during the study conduct and you may keep the GCP training evidence received by the key study personnel.
Other comments are appreciated.
Regards,
Debbie.
You may ask the CRO to provide any certification (if they have any) stating the GCP compliance from any of the regulatory agency (may not be same agency to which you have submitted the study) and if no formal certification is available, you may ask for the list of audit reports and compliance reports for regulatory audits different regulatory audits conducted at that CRO indicating that procedures are established for regulatory compliance.
In addition, ask the principal investigator to give a declaration stating that GCP was followed during the study conduct and you may keep the GCP training evidence received by the key study personnel.
Other comments are appreciated.
Regards,
Debbie.
Complete thread:
- Evidences for GCP Jasim Uddin 2012-08-23 20:52
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