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Registerinstitutional ethics committee audit [GxP / QC / QA]
Hi vivekanand,
This is one of the sore areas of GCP. ICH E6 is not very specific about it; in countries where you buy the service from an IEC/IRB it is quite common to audit them. This would be e.g. in USA. In other countries it may not be common at all, and sometimes the IEC will even not accept to be audited.
I personally think auditing IEC's/IRB's is a clear necessity in some cases.
❝ Please suggest me that Quality assurance unit of CRO has the right to audit Institutional ethics committee working for the CRO
❝
❝ However QA (quality assurance) and Ethics committee operates independently.
This is one of the sore areas of GCP. ICH E6 is not very specific about it; in countries where you buy the service from an IEC/IRB it is quite common to audit them. This would be e.g. in USA. In other countries it may not be common at all, and sometimes the IEC will even not accept to be audited.
I personally think auditing IEC's/IRB's is a clear necessity in some cases.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- institutional ethics committee audit vivekanand 2013-05-24 14:17
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- institutional ethics committee auditElMaestro 2013-05-24 14:57
- institutional ethics committee audit drgunasakaran1 2013-05-24 18:12
Ing. Helmut Schütz