Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1) Revision 3 of March 2010
Hi Everyone, I would like to get peoples opinion on the submission of revisions to informed consent documents to Reg/Ethics in light of this revised detailed guidance. Note that the revised detailed guidance is also applicable for ethics committees (despite the title!!!) The guidance is very clear that "substantial" amendments are submitted to Reg/Ethics for approval and that "non-substantial" amendments are not submitted to Reg/Ethics - the sponsor may implement non-substantial changes without Reg/Ethics approval.
In the case that a "non-substantial" change is made to an ICF (so for example and administrative update that does not have significant impact on patient safety etc) then would you think that the change can be implemented without prior review/approval by a Reg/Ethics committee? In light of this new guidance it seems very clear that if a sponsor classifies the amendment as non-substantial then there is no requirement for submission to appropriate body. But ICHGCP does state that important changes to the ICF have to be prior reviewed by IRB/IEC before they can be used. So I think that there is still some ambiguity
I would really appreciate any thoughts on this.
Many Thanks.
