gracehung
☆    

Taiwan,
2014-02-11 12:44
(4519 d 20:55 ago)

Posting: # 12393
Views: 1,605
 

 Retention of testing sample [Regulatives / Guidelines]

Dear all,

After completion of clinical trial, could we send the retention samples from trial site back to CRO who conduct project management, bioanalysis, PK/statistical analysis and issue final report? And could we retain the reserve samples in CRO?
According to FDA guideline, the reserve samples should not send back to the study sponsor or drug manufacturer. Could we look on the CRO as a independent third party?

Best Regards,

Grace
UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,572 registered users;
366 visitors (0 registered, 366 guests [including 16 identified bots]).
Forum time: 10:39 CEST (Europe/Vienna)

The real struggle is not between the right and the left
but between the party of the thoughtful
and the party of the jerks.    Jimmy Wales

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5