Contracting

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. 

Campus Leads
 

Erick Jenkins, UCD

Valerie Ody, UCD

Tam Tran, UCI (Work Group Lead)

Tamika Merrick, UCLA

Maria Rutecki, UCLA

Sanaz Masha, UCSD

Lauren Sanfilippo, UCSD

Monica Smith, UCSF
Andrew Jones, UCOP



Contact
David Grady
Program Coordinator, UC BRAID
david@ucbraid.org

415-514-8281

Goals

  • 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

   1. Home

   2. Study Plan

   3. Protocol

   4. Budget

   5. Funding

           5a. Multiple Funding Sources

   6. Modifications and Changes

   7. Other Situations

           7a. Correlative Studies

           7b. Subcontracts

           7c.  Consortium Agreements

Contracting Rationales Library

The 5 UC Academic Medical Centers and UCOP are creating 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 is expected to be completed and available to UC contracting officers in Winter/Spring of 2019/2020.

 

Collaboration in Action

Measuring and Improving Contracting Performance in the University of California Contracting Network

ABSTRACT
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. 

Authors

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

© 2019 by the University of California Biomedical Research, Acceleration, Integration, & Development (UC BRAID).
Question? Email: info@ucbraid.org