Dear Clinical Research Community,
As part of our ongoing commitment to enhancing operational efficiency and incorporating valuable insights from our inaugural OCTA customer experience survey, we are excited to announce several updates scheduled to take effect in January 2024.
New Training Opportunities:
We are introducing two advanced series courses designed to further empower our clinical research professionals:
- CTO 203: Coverage Analysis Guidance and Concepts: A comprehensive exploration of coverage analysis (CA), including its significance, determining when a CA is necessary, collaboration with analysts, review processes, and study team sign-off.
- CTO 204: Clinical Trial Budgeting Guidance and Concepts: In-depth coverage of clinical trial budget components, effective collaboration with analysts, review procedures and negotiation strategies with industry partners.
Target Audience: CRCs, Clinical Research Supervisors/Managers, and PPMs involved in industry-sponsored clinical trials with the Office of Clinical Trial Activation.
Required for staff members delegated by the Principal Investigator to approve draft coverage analysis and internal budget.
Changes to Budgeting Services:
Starting January 2024, budgeting services will be exclusively reserved for studies where OCTA handles the budget draft and negotiations with the industry sponsor. For studies managing their own clinical trial budgets, please utilize our online resources available here UCSF Budgeting Services.
- Procedural Pricing Estimates:
- If OCTA is not preparing the study budget, use the OCTA Procedural Pricing Request Form for price estimates related to costs billed in APeX (or Epic).
Study Pipeline Updates:
We understand legitimate delays may occur, and our team is available to address concerns and expedite the process. To ensure that our resources are used effectively and to streamline our operations, we propose to cancel OCTA submissions that are unable to proceed.
- Cancellation Policy:
- Studies on hold for more than 45 consecutive calendar days will be canceled in the OCTA pipeline if no actionable reply is received within 7 days of notification.
- This is not a termination or withdrawal of your study but a pause in the review process within OCTA.
- You can resubmit your study when ready via the Clinical Trial Activation Request Form.
- Check Your Study Status:
- Monitor the status of your OCTA study submission through the Current Activation Pipeline Dashboard.
- Mitigate delays by reviewing target completion dates and sharing these dates with your study sponsor.
- Please submit your study to OCTA and the IRB of record within 14 calendar days of each other.
We remain dedicated to providing exceptional support, and our team is ready to assist with any inquiries or challenges you may encounter. Feel free to reach out and let us work together to ensure a smooth and efficient activation process.
Thank you for your continued collaboration.
Best regards,
Christy
Christy Anton, MBA
Director, Office of Clinical Trial Activation | OCTA
University of California, San Francisco
Campus Box 0962 | San Francisco, CA 94158
tel: 628.286.5154
Find the status of your OCTA study submission here:
Current Activation Pipeline Dashboard
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