Epanova | AMRN Message Board Posts

Amarin Corporation plc

  AMRN website

AMRN   /  Message Board  /  Read Message

 

 






Keyword
Subject
Between
and
Rec'd By
Authored By
Minimum Recs
  
Previous Message  Next Message   Post Message   Post a Reply return to message boardtop of board
Msg  4409 of 4736  at  6/20/2019 8:57:58 AM  by

sphericalkutz


 In response to msg 4405 by  ex_hacker202
view thread

Re: Epanova

 In the situation you describe, it is highly likely that each patient still in the trial would need to sign a new version informed consent that reflects the important changes made to the trial (i.e. length change in the trial given the circumstances).  
 
In longer term run studies it is not uncommon for there to be 2 or even 3 versions of the informed consent signed and on file at the site.  it is not uncommon for there to be several amendments to protocols do to study duration as we'll.  
 
Its a pain for sites and monitors to track just like IND safety reports issued during long term studies are a pain to track and get acknowledgement by each sites IRB.   Each sites IRB would have to approve of the changes prior to initiating the process of re-consenting with the new version.  Oh the paperwork!
 
As always, the patient is allowed to continue by signing the revised consent or withdrawing of consent and exiting the study.  The patient is allowed to do this at any point in the trial anyway for a number of different reasons and that is standard language in the designed consents. 
 
JMO
 
kutz 


     e-mail to a friend      printer-friendly     add to library      
| More
Recs: 2     Views: 132
Previous Message  Next Message   Post Message   Post a Reply return to message boardtop of board

Replies
Msg # Subject Author Recs Date Posted
4412 Re: Epanova ex_hacker202 0 6/20/2019 11:24:47 AM


About Us  �  Contact Us  �  Follow Us on Twitter  �  Members Directory  �  Help Center  �  Advertise
Not a member yet? What are you waiting for? Create Account
Want to contribute? Support InvestorVillage by donating
� 2003-2018 Investorvillage.com. All rights reserved. User Agreement
   
Financial Market Data provided by
.


Loading...