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dshah ★★ India/United Kingdom, 2021-03-02 17:19 (1143 d 04:13 ago) Posting: # 22238 Views: 2,384 |
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Greetings All! Generally sponsors does monitoring for clinical phase, but up to how much extent sponsor can monitor ongoing bioanalysis? As per WHO- QA of CRO can decide up to which extent the data can be shared during ongoing analysis, but can sponsor completely monitor the bioanalysis? In my opinion, sponsor shall not monitor the BA phase as they can influence the analysis and ultimately the study outcome. They may assign thir party for monitoring of BA phase. Regards, Dshah |
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Ohlbe ★★★ France, 2021-03-04 19:24 (1141 d 02:08 ago) @ dshah Posting: # 22243 Views: 1,868 |
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Dear Dshah, The bioanalytical part of the study is just as important as the clinical part and should deserve just as much QC and QA efforts from the sponsor as the clinical part. Therefore having the sponsor monitor or audit bioanalysis is, in itself, not a problem and I would actually encourage a better sponsor oversight. What could be discussed is whether the monitoring or audit could take place in-process or only once activities are completed. However if you have processes in place with robust SOPs and stick to them, and make clear to the sponsor representatives in advance that they shall not try and influence in any way e.g. the acceptance of analytical runs or the re-analysis of certain samples, but only check compliance with GCP, GLP and your SOPs, it should be feasible. Still, I would recommend never to leave the sponsor representative alone with junior staff and to ensure there is always somebody there with enough authority to resist undue sponsor pressure. — Regards Ohlbe |
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dshah ★★ India/United Kingdom, 2021-03-06 05:32 (1139 d 16:00 ago) @ Ohlbe Posting: # 22249 Views: 1,856 |
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Dear Ohlbe! Actually I am from sponsor side. I agree for oversight or even the review of run that has completed, but shall sponsor monitor on going BA runs? ❝ make clear to the sponsor representatives in advance that they shall not try and influence in any way So shall CRO share their SOP and then sponsor shall make agenda? Thank you for your guidance. Regards, Dshah |
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Ohlbe ★★★ France, 2021-03-09 00:12 (1136 d 21:20 ago) @ dshah Posting: # 22251 Views: 1,776 |
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Dear Dshah, ❝ […] shall sponsor monitor on going BA runs? Up to you. It is neither made mandatory, nor forbidden by any guideline, as far as I know. ❝ ❝ make clear to the sponsor representatives in advance that they shall not try and influence in any way ❝ So shall CRO share their SOP and then sponsor shall make agenda? The CRO should either make their SOPs available in advance (so that the monitor or auditor can prepare his visit) or at least make them available at the site during the visit. The monitor or auditor will decide what he wants to monitor or audit based on the sponsor's own SOPs and using his brain. But again, he should check compliance with regulations, guidelines and the lab's SOPs, but not interfere with the study conduct. Decisions remain with the study director, in accordance with GLP. — Regards Ohlbe |
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dshah ★★ India/United Kingdom, 2021-03-09 18:01 (1136 d 03:31 ago) @ Ohlbe Posting: # 22253 Views: 1,754 |
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Greetings Ohlbe! Thank you for your valuable suggestion. Regards, Dshah |
Ing. Helmut Schütz