Log in
Register|
santosh ☆ India, 2012-12-21 14:37 (4935 d 06:15 ago) Posting: # 9741 Views: 5,088 |
|
|
Dear Sir, we had planned BE, replicate, four period study of sample size 40. But in First period due to short of Volunteers we planned to do study in two groups with 20 subject in each group. My question shall I have to follow same pattern in next three periods or I will go with 40 subjects in set as I was planned first. Regards, Santosh Edit: Category & subject line changed. [Helmut] |
|
drgunasakaran1 ★★  2012-12-22 13:20 (4934 d 07:31 ago) @ santosh Posting: # 9746 Views: 4,290 |
|
|
Dear Mr Santosh, ❝ But in First period due to short of Volunteers we planned to do study in two groups with 20 subject in each group. You cannot change the Study design (from single group to multiple groups) during the study execution for the reason of shortage of volunteers. It is a major protocol violation. If you have captured the execution of studies in groups in the EC approved protocol itself, then you can execute the study. In that case, it is preferable to dose in two groups for the remaining periods also. — 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 |
|
santosh ☆ India, 2012-12-24 09:09 (4932 d 11:42 ago) (edited on 2012-12-24 13:54) @ drgunasakaran1 Posting: # 9751 Views: 3,834 |
|
|
Dr_Dan ★★ Germany, 2012-12-27 13:17 (4929 d 07:35 ago) @ santosh Posting: # 9757 Views: 3,236 |
|
|
Dear Santosh As far as I understood you already started the first group. For the second group the study conduct should be the same as for the first group, i.e. it will not be possible to run the remaining periods with both groups together at the same time since then you would have different wash out periods between the treatments. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
|
santosh ☆ India, 2012-12-27 13:34 (4929 d 07:17 ago) @ Dr_Dan Posting: # 9758 Views: 3,231 |
|
|
Helmut ★★★   Vienna, Austria, 2012-12-27 15:50 (4929 d 05:01 ago) @ santosh Posting: # 9760 Views: 3,202 |
|
|
Dear Santosh, we had to edit all your replies so far. Please follow the Forum’s policy in the future and delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! — 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 |
Ing. Helmut Schütz