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
While this campaign will be an ongoing and iterative process, the 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
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.
Element |
What this means |
Improved Result |
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Improving the activation process through pre-submission quality-check tools for study teams:
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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. |
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Optimizing parallel processing by training study teams to submit materials in parallel:
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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.
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Enhancing the IRB review process with PI engagement with committees: |
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. |
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Streamlining the budget and coverage review process:
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Study teams will benefit from a single budget and coverage workflow to obtain approval in one touchpoint.
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This reduces steps in review and sign-off processes for budgets and coverage analysis and streamlines communication between OCTA and the study team. |
Coming in 2024
Additional campaign elements will be rolled out starting in Q1 of 2024, including:
- Enhancements for studies recruiting non-English speaking populations
- Focus on challenges at our affiliate sites with variable workflows
- Providing additional tools, training courses, and best practices to a variety of study designs and Sponsorships
- And more!
Get Involved
The CTEC 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.
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].
Town Hall Meeting
Date |
Topic |
Speakers |
Recording |
| October 16, 11 a.m. – 12 p.m. | Quarterly Office of Research Town Hall – October 2023 |
Speakers & Topics
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Recording |
Frequently Asked Questions
1. Are all these improvements relevant to my research?
You may find some campaign elements more useful than others depending on the nature of your research. Please use this Qualtrics form to get in touch with the unit(s) responsible for the optimizations that will be most useful for your work.
2. How will you measure success?
Our initial metric of success is shorter activation time for study teams, meaning that teams will be able to bring their idea to fruition in a shorter amount of time and using a more streamlined and efficient process.
3. 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!
4. What are the campaign’s values?
The CTEC is rooted in the following values to foster the best outcomes for all stakeholders in the clinical trial activation process:
- Engagement, collaboration, and synergy
- Equity and diversity across participants, PIs, and study teams
- Service and responsiveness
- Shared responsibility and accountability
- Transparency, trust, and open dialogue