Contracting

OVERVIEW

The current UC contracting landscape is perceived by investigators as cumbersome, time consuming and a factor in delaying the start of clinical studies. By industry it is perceived as a major barrier to partnership particularly for multi-site studies. The contracting initiative is tasked with identifying policy changes, new infrastructure, standardized procedures or processes that will reduce the barriers to clinical research contracting for the institution, for individual researchers, and external partners.

GOALS 

  • Assess current contracting processes, determine potential causes of variability and delay, and develop processes for improvement 
  • Improve communication efforts across the UC system through training, work groups and tools that support collaboration and communication
  • Provide resources to the UC research community in support of consulting engagements 

ACCOMPLISHMENTS to DATE

  • Increased number of UC-wide Master Clinical Trial Agreements (CTAs): UCOP led efforts to meet the initial goal of establishing Master CTAs with 5 major companies was met, surpassed and doubled in 2011 and the number of master CTAs continue to grow.
  • Standardized Material Transfer Agreements (MTAs): UCSD led efforts for all UC campuses to have a single consolidated office for managing MTAS. UC-wide agreement to use the UBMTA template as the default agreement was reached.
  • Developed the Online Training for Clinical Trial Negotiators Program: UCOP led in the development and implementation of the curriculum. Content provides new contracting employees with the background knowledge needed to negotiate agreements and ensure consistency in training across the UC campuses
  • Conducted pilot data collection study to measure contract negotiation and execution processes across 5 UC biomedical campuses. Analyses are ongoing and will continue to inform process evaluation and improvements for trial activation and understand the time needed to complete these processes.
  • Development of a UC-wide clause library prototype: UC Irvine led efforts to develop a prototype, production version of the clause library. A process for deployment of the clause library at interested campuses is being developed.
  • Piloted a UC-wide contracts database: UCSF led efforts to develop a secure, production version of the UC-wide centralized repository of contracts, searchable to find companies, terms and types of studies.  Future goals include establishing definitions and evaluating implementation at each campus.

LEADERSHIP

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S. Claiborne (Clay) Johnston,
MD, PhD 
Director, Clinical and
Translational Science Institute
Assoc Vice Chancellor of Research
UC, San Francisco
clay.johnston@ucsfmedctr.org
P: 415-502-7487  


Helene Orescan, JD
Director, Clinical Trials Administration Office
UC, Los Angeles
horescan@mednet.ucla.edu
P: 310-794-0137

CONTACT

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Rachael Sak, RN, MPH
Clinical and Translational Science Institute
UC, San Francisco
rachael.sak@ucsf.edu
P: 415-514-8058