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vivekanand ☆ India, 2013-05-24 16:17 (4758 d 10:38 ago) Posting: # 10642 Views: 6,379 |
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Dear All 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. comment required! Also can U provide me any reference for the same Regards G.Balavivekanand Edit: Category changed. [Helmut] |
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ElMaestro ★★★ Denmark, 2013-05-24 16:57 (4758 d 09:59 ago) @ vivekanand Posting: # 10643 Views: 5,088 |
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Hi vivekanand, ❝ 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. — Pass or fail! ElMaestro |
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drgunasakaran1 ★★  2013-05-24 20:12 (4758 d 06:43 ago) @ vivekanand Posting: # 10650 Views: 5,222 |
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Dear MR Balavivekanand, ❝ Please suggest me that Quality assurance unit of CRO has the right to audit Institutional ethics committee working for the CRO QA department of a CRO can audit the Institutional Ethics Committee. Most of the Indian CROs QA department used to do the same. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
Ing. Helmut Schütz