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raghavendra_s ★ 2010-05-25 11:15 (5463 d 21:46 ago) (edited on 2010-05-25 12:18) Posting: # 5371 Views: 6,328 |
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Dear Madam/Sir, In a BA/BE setup, usually companies have screening and study specific ICF to make sure that they screen large number of volunteers so that they can be enrolled in the studies with in 21 days from screening. If the company has one single ICF which talks about both screening and study specifics and they screen 50 volunteers but study requires 20 volunteers. Can we put remaining 30 screened volunteers in another study after reconsenting for the other study without screening them within 21 days. Kindly suggest. Thanks and regards, |
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bharat ☆ India, 2010-05-25 13:51 (5463 d 19:09 ago) @ raghavendra_s Posting: # 5373 Views: 5,443 |
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Dear Raghavendra yes, you can include that subject with consent for other study. but you should have study specific icf and for screening if any additional test is there in relation with drug then you shoud carried out that extra test. if u have any concern pls. let me know regards bharat Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post and that one! [Helmut] |
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Helmut ★★★   Vienna, Austria, 2010-05-25 13:56 (5463 d 19:04 ago) @ raghavendra_s Posting: # 5374 Views: 5,347 |
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Dear Raghavendra, "leftover subjects"?! In using such a term I suspect you see them as objects rather than human beings. Reconsider you ethical approach to clinical studies. — 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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raghavendra_s ★ 2010-05-25 17:46 (5463 d 15:14 ago) @ Helmut Posting: # 5377 Views: 5,270 |
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Dear Helmut, Thank you for correcting me. Its not my true intention to treat/call the research participants unethically. Its happened due to my poor language editing skills. Kind regards, |
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Helmut ★★★ Vienna, Austria, 2010-05-25 19:01 (5463 d 14:00 ago) @ raghavendra_s Posting: # 5378 Views: 5,272 |
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Dear Raghavendra, sorry for my rude tone. Coming from a post-Nazi-country I'm sensitized to everything sounding like "Human Guineapigs". — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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YT ☆ Thailand, 2010-05-25 14:06 (5463 d 18:54 ago) @ raghavendra_s Posting: # 5375 Views: 5,293 |
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Dear raghavendra_s IMHO I think we could not automatically enroll the remain subject to be studied for the new project. The reason is those subjects signed the ICF for the specific study. Although you will work on a new ICF for new study, but the activities about laboratory screening and physical examination will happen before the new ICF has been signed. YT |
Ing. Helmut Schütz