Clinical Trial Excellence Campaign (CTEC)

The Clinical Trial Excellence Campaign (CTEC) aims to scale tried and tested operational improvements to the clinical trial activation process.

Clinical trials are foundational to discovery and treatment development in human research. To start or “activate” a clinical trial at UCSF requires strong collaboration across multiple stakeholders and application of best practices.

Units within the Office of Research have been working behind the scenes to identify these best practices to optimize clinical trial activation. We now know what operational changes can make your research journeys easier and more effective and are making it a priority to introduce these optimizations to more study teams.

Campaign Goals

The campaign is an ongoing and iterative process aiming to improve internal and external engagement, knowledge and satisfaction of key stakeholders including study staff, investigators, sponsors and CROs.

Initial goals are to:

Shorten activation times* and improve the overall activation process
Improve communication and transparency on the activation process
Develop a culture of shared responsibility between operational units, study teams, and external stakeholders including sponsors and CROs

*A key metric of performance in the campaign is the time from first submission of a protocol into the system (IRB or OCTA) through to contract execution. The campaign aims to achieve an institutional median of 90 days for this metric.

Campaign Elements

Below are four key elements that study teams can engage with as the campaign begins. Please note that some elements may be more relevant to your research than others.

Streamlining the coverage and budget review process

What this means

Improved Result

Resources

Study teams now benefit from a single budget and coverage workflow to obtain approval in one touchpoint.

As part of the Campaign, the goal for review and approval is 5 calendar days.

This reduces steps in review and sign-off processes for budgets and coverage analysis and streamlines communication between OCTA and the study team.

NEW: Monthly Advanced Trainings for Study Staff:

CTO 203: Coverage Analysis Guidance & Concepts
CTO 204: Clinical Trial Budgeting Guidance and Concepts

NEW: Combined CA/Budget Review Guide for PIs and Study Teams

NEW: PI Proxy approval of the draft coverage analysis and internal budget. Delegation of this responsibility is at the discretion of the PI and their department. The above training courses are required for any staff.

PI: Please click here to approve delegation.

Improving the activation process through pre-submission quality-check tools for study teams

What this means

Improved Result

Resources

Study teams will use tools and checklists to guide the submission process. Process guidance will also be given to Sponsors to elucidate the offices and analysts working on different aspects of activation.

Sponsors will be able to review and approve mandatory informed consent language before the study team drafts the ICF.

This reduces back and forth with Sponsors on document prep and review and provides greater transparency of the steps within the activation process.

NEW: Study Team Guide
for UCSF Industry Clinical
Trial Activation

NEW: Sponsor Guide for
UCSF Clinical Trial
Activation

Optimizing parallel processing by training study teams to submit materials in parallel

What this means

Improved Result

Resources

Study teams will be prepared to submit materials to various systems simultaneously, rather than submitting in a serial fashion.

This reduces the number of days between system submissions and optimizes the opportunity for central units to process the contract, budget/coverage analysis, and regulatory review in parallel. This will also help maintain version control across units.

NEW: Study Team Guide
for UCSF Industry Clinical
Trial Activation

NEW: Sponsor Guide for
UCSF Clinical Trial
Activation

Enhancing the IRB review process with PI engagement with committees

What this means

Improved Result

Resources

In cases where it is deemed to be beneficial, PIs may be invited to attend IRB Committee meetings during which their study is being reviewed to address any questions and concerns.

Near 50% reduction in median time to IRB approval, compared to clinical trials that did not apply this method.

"Attending the IRB meetings as Principal Investigator has facilitated addressing potential queries in real-time as well as gaining a deeper understanding and appreciation for the specific issues that are considered by the IRB during the trial activation process. I see this as a valuable step in the trial activation process particularly for investigator-initiated trials."

Rahul Aggarwal, MD

NEW: To support strong UCSF IRB applications and reduce IRB approval time use the UCSF IRB Initial Submission Checklist

New in 2024

Additional campaign elements will be rolled out starting in Q1 of 2024, including:

Optimizing activation when recruiting non-English speaking populations
Focus on activation workflow challenges at ZSFG
Improving the activation process by providing additional tools, new and updated training courses, and best practices to a variety of study designs and sponsorships
And more!

Get Involved

The campaign is now in a phase where we need your collaboration! As you start to use the new campaign offerings, or engage in parts of the new activation process, we encourage your feedback to enrich this iterative process and make these changes even better.

What our central teams will offer:

Operational scaling of initiatives shown to be effective
Training, resources, and support for CTEC initiatives
Outreach to study sponsors
Continual internal effort and initiatives for process improvement

Requests from study teams, sponsors and CROs:

Engagement with our new processes and trainings
Feedback on what is working well and what is not working well
Commitment to collaboration

Are you a study Sponsor or Clinical Research Organization (CRO) that wants to get involved or learn more about this initiative? Contact us at [email protected].

Meetings

September 2024 - IRB DEIA Efforts

Date & Time

Speakers & Topics

Materials

September 25, 2024

12:10 pm – 1 pm

Edward Kuczynski, Director, Human Research Protection Program (HRPP)
UCSF Institutional Review Board’s (IRB) Diversity, Equity, Inclusion, & Accessibility (DEIA) Efforts

April 2024 - UCSF CTEC Sponsor & CRO Webinar

Date & Time

Speakers & Topics

Materials

April 24, 2024

12 pm – 1 pm

Dominica Randazzo, Associate Director for CTO
UCSF CTEC Sponsor & CRO Webinar

Recording

March 2024 - CTO Research Forum

Date & Time

Speakers & Topics

Materials

March 7, 2024

12 pm – 1 pm

Dominica Randazzo, Associate Director for CTO
Industry Clinical Trial Activation Guide for study teams

Recording

October 2023 - Quarterly Office of Research Town Hall

Date & Time

Speakers & Topics

Materials

October 16, 2023

11 am – 12 pm

Harold Collard, MD, MS
Welcome, About the Office of Research
Natalie Nardone, PhD and Payam Nahid, MD, MPH
About the Clinical Trial Excellence Campaign
Ida Sim, PhD, MD and Mandy Terrill
Uses of High-Performance and Knowledge Computing in Research

Recording

Frequently Asked Questions

Are all these improvements relevant to my research?

How will you measure success?

Are the current campaign components all that you will cover?

This is only the beginning! The CTEC plans to introduce even more elements starting in Q1 2024, including:

Enhancing studies recruiting non-English speaking populations
Focusing on challenges at our affiliate sites with variable workflows
Providing central support (e.g., navigator, liaison) to point teams towards needed resources
Providing additional tools, training courses, and best practices to a variety of study designs and Sponsorships
And more!

What are the campaign’s values?

I-TAM does not account for study activation time prior to submission to the IRB or OCTA. How do you aim to support study teams in this work?

We recognize the time a protocol spends in the activation pipeline does not account for the time that study teams and sponsors and other stakeholders spend in start-up for a clinical trial. Throughout the campaign, tools, guides, and training will be available to support study teams and sponsors. Many of these will directly support the pre-submission process and streamline the activation pipeline for central processing.

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