August 2026: Issue 006

Message from the CCR Co-Directors

Dear CCR Community,

Welcome to August issue of the CCR Newsletter! As summer winds down and we head into fall, we're excited to share a few important updates with our study teams.

First, we're pleased to announce a new Chair for our Faculty Advisory Council (FAC): Dr. Jennifer Graves. We're grateful for her leadership as the FAC continues to evolve, and we invite you to read more about Dr. Graves later in this issue.

We also want to flag two upcoming opportunities to connect with us directly. Our next Study Team Town Hall will be held virtually on August 27. We'll also host a special virtual Bioinformatics, Biostatistics, and Data Science (BIDS) Study Team Town Hall on September 11, to provide updates and gather feedback on several BIDS offerings, including e-Recruitment, Epic Forward, Cloud DX, and related initiatives. We encourage all study team members to attend — these sessions are a great chance to ask questions, share feedback, and stay current on CCR resources and processes.

As always, thank you for your continued partnership. We look forward to a productive fall together and to seeing you at the upcoming Town Halls.

Warm regards,

Dr. Kathryn Gold and Dr. Mark Wallace,

Co-Directors, ACTRI CCR

CENTER FOR CLINICAL RESEARCH (CCR) UPDATES

Meet the incoming FAC Chair, Dr. Jennifer Graves

Leading the ACTRI's Faculty Advisory Council (FAC) is the new FAC Chair Dr. Jennifer Graves, MD, PhD, MAS. Dr. Graves is Vice Chair of Human Research and Professor of Neurosciences at UC San Diego. She is dual fellowship trained in neuroimmunology and neuro-ophthalmology and directs the multiple sclerosis centers and research programs at UC San Diego, Rady Children's Hospital, and the San Diego VA. She brings extensive experience in multi-center clinical trials and a strong commitment to advancing UC San Diego's research enterprise.

The FAC is comprised of UC San Diego faculty investigators and gives study teams a direct channel to ACTRI leadership, which ensures the concerns, ideas, and day-to-day experiences of the research community shape how ACTRI operates and evolves.

Meeting monthly, FAC members represent their departments by surfacing feedback, flagging barriers to conducting clinical research, and advising leadership on ways to strengthen workflows, policies, and services. The Council also helps shape the agenda for CCR Town Halls and reviews the insights that come out of them.

Current additional FAC Members:

Dr. Monica Tincopa — Gastroenterology
Dr. John Ravits — Neurology
Dr. Michael Wilkinson — Cardiology

Interested in Joining the FAC?

The FAC is actively recruiting new members. UC San Diego faculty investigators who want to help shape the future of clinical research at ACTRI are encouraged to apply. Contact ACTRI-CCR@health.ucsd.edu for more information.

New Hazardous Clean Room Facility Now Available at ACTRI IDS

The Investigational Drug Service (IDS) pharmacy at ACTRI has completed construction and certification of a new hazardous compounding clean room, now fully operational to support investigational drug preparation for trials involving hazardous and biohazardous agents.

Facility Capabilities

The new clean room is equipped with:

A certified Biological Safety Cabinet (BSC) for hazardous sterile compounding
A dedicated glovebox for handling biohazardous materials, including gene therapy products and other advanced therapeutics requiring specialized containment

The facility is certified in accordance with USP <800> hazardous drug handling standards and institutional environmental health and safety requirements, and is staffed by IDS pharmacy personnel trained in hazardous and biohazardous product handling.

What This Means for Study Teams

Study teams planning trials involving hazardous compounds, cytotoxic agents, gene therapies, or other biohazardous investigational products can now utilize ACTRI IDS for:

Hazardous and biohazardous sterile compounding and preparation
Storage and handling of investigational products requiring specialized containment
Support for trials previously limited by lack of on-site hazardous compounding capability

IDS encourages study teams with upcoming or active protocols involving these product types to reach out to IDS early in study start-up so they can plan pharmacy workflows, staff training coordination, and any site-specific requirements. Contact CTRI-IDSPharm@ucsd.edu with questions or to begin planning.

IDS looks forward to supporting the research community with this expanded capability and to help bring more complex, high-impact trials to UC San Diego Health.

Coming Soon: New Clinic Lab Sample Tracking System

The ACTRI La Jolla Main Clinic lab is transitioning from a paper and Excel-based process to a new digital sample tracking system, designed to improve visibility, strengthen the audit trail, and streamline communication with study teams.

Once launched, coordinators and study team members will receive an automated email confirming receipt of each logged sample, including key details such as storage location and the sample's unique ID — creating a clear, documented record for study files.

Clinic staff training is underway, with full rollout anticipated in the coming weeks. The new process will be incorporated into the CCR-017 ACTRI Clinic Laboratory Daily Operations SOP (PDF), and an updated SOP will be shared once finalized. A separate communication will also follow with more details on the new workflow, notifications, and the process for handling samples nearing their storage timeframe. Reminder that the placement of specimens into the freezers and refrigerator will continue to be the responsibility of clinic staff only. Watch for updates in your inbox and future newsletters.

One CCR Team Building — November 6

On November 6 from 1 to 4 PM, CCR staff will come together for our second One CCR Team Building session, building on the momentum and findings from our first meeting. Most staff will be unavailable during this time; however, all currently scheduled visits will be conducted as planned.

For urgent issues, contact the respective unit:

Clinics: Bernadette Cale at bcale@health.ucsd.edu
CRC: Fanny Delebecque at fdelebecque@health.ucsd.edu
CTSS: Ana Bhatt at abhatt@health.ucsd.edu

CCR Newsletter Archive Now Available

Missed a previous issue of the CCR Newsletter? Past editions are now archived and available anytime on the ACTRI website. Bookmark the page to catch up on updates, resources, and highlights from across the Clinic, CRC, and CTSS.

UPCOMING EVENTS

Study Team Town Hall

Date: August 27, 2026, 11 AM - 12 PM
Location: via Zoom
Study team members are invited to join CCR leadership for operational updates and open discussion. This forum provides an opportunity to share feedback and discuss priorities impacting clinical research support services.

If you would like to join this town hall and you have not yet received an invitation please email Amy Westermann at a2westermann@health.ucsd.edu.

Biomedical Informatics and Data Science (BIDS) Study Team Town Hall

Date: September 11, 2026, 10 - 11 AM
Location: via Zoom
Study team members are invited to join to hear about BIDS offerings, including e-Recruitment, Epic Forward, Cloud DX, and related initiatives.

If you would like to join this town hall and you have not yet received an invitation please email Amy Westermann at a2westermann@health.ucsd.edu.

CCR REMINDERS

CTSS FDA Submission Support — CTSS offers dedicated, full-service support for your FDA submission needs, from FDA communication and pre-IND/IDE meeting prep to complete IND/IDE submission management, so you can focus on the research. Reach out at actri-ctss@health.ucsd.edu to learn more.
Clinic Lab Computer Access: The computer in the corner of the La Jolla Main clinic lab is reserved for ACTRI staff only. Clinic leadership asks that CRCs and study team members use the computer located near the freezer instead. This is to prevent the data overload of the computer used by clinic lab staff.

CRC Service Spotlight: Research Expertise You Can Count On

Whether you're launching a multi-site PI-initiated research study, conducting a Phase I trial, or managing a complex industry-sponsored gene therapy clinical trial, ACTRI's experienced Clinical Research Coordinators (CRCs) are ready to support your success every step of the way. No study is too simple or too complex for our team.

With the flexibility to work across multiple UC San Diego Health campus locations throughout the city, our team brings expert research support wherever it's needed, helping your study run smoothly from start-up through closeout. Contact ACTRI-coordservices@health.ucsd.edu for any questions.