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