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kishan_123 ☆ India, 2019-11-06 16:27 (1630 d 00:05 ago) Posting: # 20757 Views: 3,870 |
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Dear Forum, Greetings. I would like to know your views on following situation. If a clinical site have only one PI and there are no other senior person such as Director/Head other than PI. In Such Case QA should report to whom and all the QA SOP should be reviewed & Approved by whom. Would appreciate your feedback. Regards, Kishan |
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PharmCat ★ Russia, 2019-11-07 18:18 (1628 d 22:15 ago) @ kishan_123 Posting: # 20761 Views: 3,094 |
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Hello! What quality standards do you implementing? |
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kishan_123 ☆ India, 2019-11-11 06:01 (1625 d 10:32 ago) @ PharmCat Posting: # 20781 Views: 3,041 |
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❝ What quality standards do you implementing? Hello,, We are implementing Clinical Research (BABE) Quality Standards in one of the Hospital Site. Kr, |
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ElMaestro ★★★ Denmark, 2019-11-11 10:14 (1625 d 06:18 ago) @ kishan_123 Posting: # 20782 Views: 3,012 |
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Hi, ❝ If a clinical site have only one PI and there are no other senior person such as Director/Head other than PI. In Such Case QA should report to whom and all the QA SOP should be reviewed & It is not uncommon that small sites do not have a classical structure with independent QA. However, such sites are by the nature of the game usually subcontracted by someone who has the overarching QA task, and who does the auditing and final QA review. Therefore, independence of QA, which is a formally enforced requirement, is assured in such cases. The organised system with site investigator files, trial master files, source pave the way for its relatively easy implementation. The people doing QA at such sites could as well be called something else, like QC employees. — Pass or fail! ElMaestro |
Ing. Helmut Schütz