Clinical Trials

Clinical Trials Guidance and Policy

Clinical trials are biomedical or behavioral research studies in which the safety, pharmacokinetics, or therapeutic effect of an intervention, or the effectiveness of a diagnostic procedure is being evaluated. Not all Clinical Trials are Industry Sponsored, though most are.

• Budget
  • Indirect Cost Policy for Clinical Trials
  • Significant Financial Interest Disclosure (GIM 10)
• General
  • Clinical Research Budget and Billing (CRBB) Toolkit
  • Guide to Clinical Studies at the UW
  • Registering your Clinical Trial with ClinicalTrials.gov
• Human Subjects
  • Clinical Trials and the IRB
  • Enrollment Incentive Prohibition
  • Western Institutional Review Board
• Master Clinical Trial Agreements

  Company	Effective/Signed	Expiration
  Abiomed	June 25, 2008	None
  Actelion	November 21, 2008	None
  Activbiotics	June 20, 2003	None
  Amgen	May 5, 2008	None
  Bristol Myers Squibb	May 12, 2005	May 12, 2010
  Bristol Myers Squibb Medical Imaging	August 24, 2004	None
  Cephalon	January 31, 2007	January 31, 2010
  Eli Lilly and Company	August 16, 2002	None
  General Electric Medical Systems	August 19, 2004	August 18, 2011
  Glaxo Smith Kline	June 8, 2004	None
  Hoffman-LaRoche, Inc.	June 16, 2004	None
  Intermune	April 9, 2004	None
  Merck	(Revised)October 20, 2005	October 20, 2010
  Millennium Pharmaceuticals	February 24, 2009	None
  Novartis Pharmaceuticals Corp.	February 20, 2009	February 20, 2014
  Pfizer	January 31, 2009	January 31, 2014
  Roche Laboratories	June 7, 2004	None
  Sanofi-Aventis	August 6, 2008	August 6, 2013
  Vertex	December 3, 2008	None
  Medivation **	June 2007	None
  Hollis-Eden **	July 2008	None

  ** Master CTAs through the Prostate Cancer Clinical Trial Consortium, for members only.

• Templates
  • Participation Agreement (PA)
  • Preclinical Trial Nondisclosure Agreement