Management of Clinical Trials Christina K. HANSEN 30 Jun 1994 19:19 EST
I've recently subscribed to this list, so please excuse this
posting if an earlier discussion has covered this topic.
Several faculty and administrators at University of
California Irvine are discussing the possibility of setting
up an Office of Clinical Trials (OCT), which would provide
support services related to human subjects committee
applications, budgeting, cost management, and contract
negotiations. The goal is to reduce the time delays now
experienced in processing clinical studies through the IRB
and the Office of Contract and Grant Administration.
Currently, OCGA negotiates the clinical trial agreements and
would continue to have authority for this aspect of the
process. One model is to have OCGA run the entire OCT.
Since I'm responsible for both the IRB and the Contracts and
Grants staff, this could be re-engineering at its finest, or
a complete disaster offering no time or cost savings to
anyone. Thus, I'm interested in hearing from others who
have something similar at their universities. Specifically:
how is it organized/to whom does the office report?
how is it staffed?
how is it funded, i.e., is there any flat charge for
how is it working?
any suggestions for improvements?
For those who do not have such an organization, but who think they can
offer some suggestions, I'd like to hear your comments too. Send them
directly to me and I'll provide a summary to the RESADM subscribers.
Christina Hansen, Director
Office of Contract and Grant Administration
University of California, Irvine
(714)856-5677 - FAX (714)725-2094