Cancelled: Review and Finalization of CV/Death Case Report Forms for Non-Cardiovascular Studies

Dear
Registrants to the September 6th CSRC meeting;

We
are sending you this message to notify you that the September 6th CSRC meeting at
White Oak-FDA to review Cardiovascular CRF forms for use in non-CV studies has
been cancelled
.

While
we regret this last minute cancellation and any inconvenience it may create,
after direct discussion with colleagues at FDA it seems clear that there will
be far greater value to the cardiac safety objectives of this effort if we
extend the scope and the timeframe of preparations for the meeting itself.

Since
scheduling the September 6th meeting the CSRC has received an
exciting number of significant comments on the draft case report forms that
were to be reviewed.  The meeting planners felt strongly that with the degree
and diversity of comments there is a need for additional review and planning,
and hence that the September 6th meeting should be re-scheduled.

We
do plan to start a working group through the CSRC to continue to plan for an
open meeting review of these CV CRFs.  Again, we deeply apologize for any
inconvenience this may have caused for you in planning your travels.  It
is our hope that you would continue to maintain your interest in this important
area and participate in future events to be planned.  If you would like to
participate in the CSRC working/planning group on this topic, please notify
Valarie Morrow (valarie.morrow@duke.edu).  We will
keep you informed of any additional planned meetings related to CV CRFs.

 

Sincerely,

 

John
Finkle

Mitchell
Krucoff