Clinical Trials

Clinical Trials Guidance and Policy

A clinical trial is a human subjects research study whose primary purpose is to assess the safety and/or efficacy in humans of a drug, device, diagnostic, treatment, preventive measure, or similar intervention through testing of the intervention on patients in a clinical setting.

• Budget
  • Indirect Cost Policy for Clinical Trials
  • Significant Financial Interest Disclosure (GIM 10)
• Documents Required by OSP
  In order for OSP to begin working on a clinical trial agreement, the following documents must be received. It is strongly recommended that all of those documents be attached to the eGC1 when it is submitted. If they are not attached, work on the agreement will be delayed until they are received.

  • eGC1
  • Draft clinical trial agreement
  • Draft clinical trial protocol
  • Draft informed consent form
  • Sponsor contact information
• General
  • Clinical Research Budget and Billing (CRBB) Toolkit
  • Increase in HSD fee for industry-initiated clinical trials
  • 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
  AstraZeneca	July 23, 2009	July 23, 2014
  Bayer Healthcare Pharma, Inc.	June 12, 2009	June 12, 2014
  Bristol Myers Squibb	May 12, 2005	December 12, 2011
  Bristol Myers Squibb Medical Imaging	August 24, 2004	None
  Cephalon	January 31, 2007	January 31, 2010
  Cook	June 18, 2009	June 18, 2016
  Eisai Medical Research, Inc.	September 22, 2009	September 22, 2014
  Eli Lilly and Company	August 16, 2002	None
  Fred Hutch Incoming Subcontract Form	September 1, 2011	None
  General Electric Co. (Comp. Research)	January 1, 2006	January 1, 2013
  General Electric Co. and Healthcare	August 19, 2004	August 18, 2011
  Genzyme Corporation	October 1, 2009	None
  Glaxo Smith Kline	June 8, 2004	None
  Hoffman-LaRoche, Inc.	June 16, 2004	None
  Hoosier Oncology	August 3, 2011	None
  ImClone Systems Corp.	December 4, 2009	December 4, 2014
  Infinity Pharmaceuticals	February 3, 2011	February 3, 2016
  Intermune	April 9, 2004	None
  Medtronic, Inc.	May 12, 2011	May 12, 2016
  Merck(Revised)	October 20, 2005	January 20, 2012
  Millennium Pharmaceuticals	February 24, 2009	None
  Novartis Pharmaceuticals Corp.	February 20, 2009	February 20, 2014
  Novo Nordisk	September 9, 2009	None
  Pfizer (Includes Wyeth Studies: 3/25/10)	January 31, 2009	January 31, 2014
  Pharmacyclics, Inc.	July 20, 2011	None
  Roche Laboratories	June 7, 2004	None
  Sanofi-Aventis	August 6, 2008	August 6, 2013
  SCCA Network Site Agreement	August 2, 2011	August 2, 2013
  Seattle Genetics	July 22, 2010	July 22, 2015
  Vertex	December 3, 2008	None
  Medivation **	June 2007	None
  Hollis-Eden **	July 2008	None
  Kinex Pharmaceuticals **	April 2010	None

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

• Templates
  • Preclinical Trial Nondisclosure Agreement