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Ken Peh ★ Malaysia, 2014-06-21 12:31 (4391 d 11:27 ago) Posting: # 13112 Views: 3,332 |
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Dear All, Can Principal Investigator (GCP) be Study Director (GLP) in BE study ? Is there a conflict of interest or bias if the same person holds the role of Principal investigator and also Study Director ? Highly appreciate your comment. Thank you. Regards, Ken |
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Helmut ★★★   Vienna, Austria, 2014-06-21 13:11 (4391 d 10:47 ago) @ Ken Peh Posting: # 13113 Views: 2,725 |
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Hi Ken, ❝ Can Principal Investigator (GCP) be Study Director (GLP) in BE study ? IMHO, no (see below why). A person qualifying in both areas would be of a rare breed anyhow. ❝ Is there a conflict of interest or bias if the same person holds the role of Principal investigator and also Study Director ? Whereas the clinical part of BE studies generally is open, the analytical part is blinded for treatment. In your construction the Study Director could access the randomization, which is not a good idea. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Ken Peh ★ Malaysia, 2014-06-23 10:42 (4389 d 13:16 ago) @ Helmut Posting: # 13120 Views: 2,640 |
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Dear Helmut, Thank you for your comment. What if the Study Director does not involve in the analysis of samples ? Study director has no hands on. The sample are assayed by analysts who are blinded to the samples. Does it make sense ? Regards, Ken |
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PK_Lover ☆ Portugal, 2014-06-24 19:44 (4388 d 04:14 ago) @ Ken Peh Posting: # 13135 Views: 2,556 |
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Dear Ken, Study Director is the ultimate responsible for the bioanalytical work. Even if there is no hands on on the technical work the decisions are made by him so the incompatibility remains. I agree with Helmut. Regards! |
Ing. Helmut Schütz