It’s more than just a handshake. Contract negotiation is a critical part of any successful research enterprise, and our industry contracting experts are finding new ways to improve turnaround times for contract execution. From new master contracts to a toolkit for Investigator Initiated Trials, our team is on the hunt for better ways to negotiate and finalize clinical trial agreements, which gets clinical trials up-and-running more efficiently.
Erick Jenkins, UCD (Work
Valerie Ody, UCD
Tam Tran, UCI
Ann Ciminera, UCLA
Maria Rutecki, UCLA
Ursula Prins, UC Riverside
Sanaz Masha, UCSD
Lauren Sanfilippo, UCSD
Sierra Clark, UCSF
Andrew Jones, UCOP
Brian Russ, UCOP
Program Manager, UC BRAID
Measure and improve clinical trial contracting performance
Share best practices and lessons learned
Increase collaboration for multisite clinical trial agreement (CTA) negotiations
Mitigate redundant effort and conserve resources
UC Master and Accelerated Clinical Trial Agreements
UC BRAID convened a regional network of contracting directors to operationalize and measure common metrics as a basis for performance improvement efforts.
For example, when comparing the average days to contract terms finalized, both the UC Master Agreements and the Accelerated Clinical Trial Agreement (ACTA) were 45% faster when compared to the contracts which did not use a master agreement. These analyses led us to identify, share and implement best practices across our institutions.
Increasing Efficiency for Investigator Initiated Trials
Investigator Initiated Trials (IITs) may encounter pitfalls leading to study delays. These webpages provide guidance on the information needed when starting an IIT to facilitate efficient contracting and move the trial forward as quickly as possible.
Each page highlights information about elements of the study, questions that the contracting office will need answered, or checklist items for the PI to accomplish. Click here to download all the text as a pdf!
Overview of Toolkit Contents
2. Study Plan
7. Other Situations
Contracting Rationales Library
The 5 UC Academic Medical Centers and UCOP have created a document that, on a term by term basis, provides background, policies, legal requirements, resources, and negotiation recommendations to expedite clinical trial negotiations with industry.
The Library's goal is to reduce negotiation time for new and intermediate negotiators and improve consistency system-wide.
The Library has been completed and is now available to UC contracting officers.
Collaboration in Action
Measuring and Improving Contracting Performance in the University of California Contracting Network
This article summarizes the findings of an 18-month examination of performance metrics across the 5 UC health campuses, including methods for data collection and harmonization, plus operational definitions for measured variables agreed upon by the UC contracting offices.
Tam Tran, MPH, UCI
LeeAnna Bowman-Carpio, UCLA
Nate Buscher, UC BRAID
Jennifer J. Ford, MBA, UCSD
Erick Jenkins, JD, MS, UCD
Hillary Kalay, JD, MPP, UCOP
Terry Nakazono, MA, UCLA
Helene Orescan, JD, UCLA
Rachael Sak, RN, MPH, UC BRAID
Irene Shin, JD, UCSF
Pamela Davidson, PhD, UCLA