Log in
Register|
vish14184 ★ India, 2007-06-04 09:16 (6966 d 07:05 ago) Posting: # 772 Views: 5,084 |
|
|
Dear All, Can anybody tell me please contractual person became clinical investigator or not in BA/BE study. |
|
drdds ● 2007-06-04 11:11 (6966 d 05:09 ago) @ vish14184 Posting: # 774 Views: 4,041 |
|
|
Dear V, No, CI can not be contractual... Regards DDS |
|
vish14184 ★ India, 2007-06-04 12:03 (6966 d 04:17 ago) @ drdds Posting: # 775 Views: 3,970 |
|
|
Thanks DDS for your Reply, Please give me a reference. which guideline say that CI can not be contractual. If contractual CI well Qualified and trained in that case he/she became CI or not. -- Edit: Full quote removed. Please see this post! [HS] |
|
gagandeep ● 2007-06-08 09:36 (6962 d 06:44 ago) @ vish14184 Posting: # 789 Views: 3,921 |
|
|
Dear V, I know one organization where a pilot trial is currently going on with a contractual CI. I will look into the matter with interest, now that drdds is mentioning such a CI cannot exist. Would like to see any guidances relating to that.... do post a reply here in case you get to know about the guidance... Regards, Dr. Gagandeep Singh Senior Consultant Domain Consulting Team - Lifesciences Cognizant Technology Solutions |
|
hitesh shah ☆ India, 2007-06-28 09:50 (6942 d 06:31 ago) @ gagandeep Posting: # 843 Views: 3,816 |
|
|
Dear All, As per the WHO guidelines CI can be contractual. Refer 'Additional guidance for organizations performing in vivo bioequivalence studies'. Our study was approved by WHO were CI was a contractual investigator. Regards, Hitesh Shah |
Ing. Helmut Schütz