Quick Access to Commonly Used Forms and Documents

• Clinical Research Services Request Form
• Velos Access Request Form
• Study In-Service Request Form
• Current Recharge Rates
• Clinic Access Request
• ACTRI CCR Service Request Process Overview

Getting a study started at any of our research clinics follows a streamlined four-step process:

Step 1: Submit a Clinical Research Services Request Form
This form must be submitted six months before the desired study start date. It allows study teams to select from ACTRI’s suite of services needed to conduct the study, including:

• Regulatory Support (IRB Submission)
• Research Study Support (Coordinators & Language Translation)
• Clinic Use (Research Study Visits)
• Clinical Trials Project Management
• Pharmacy (Investigational Drug Services)
• Imaging Services (MRI)
• Data Safety Monitoring Board (DSMB)
• Regulatory Affairs (IND/IDE Submission)

If "Clinic Use" is selected, the form will prompt the requestor to upload the study protocol and informed consent form. Clinic management will then review the request to assess feasibility. If approved, the requestor will be notified and instructed to proceed to Step 2.

Step 2: Velos Account and Coverage Analysis Requirements
All studies utilizing ACTRI clinics must have a Velos record and study team must have a Velos account (only UCSD affiliated). To obtain Velos access, study teams must submit the Velos Access Request Form six months before the desired study start date. On the form, select "Velos Services" and complete the required fields. Velos training is required to gain access. To request Velos training please email ctri-velos@health.ucsd.edu 

If your study involves billable items at UC San Diego Health hospital, a UC San Diego Coverage Analysis (CA) is required in addition to the Velos setup to ensure proper billing of these procedures. If your study requires a Coverage Analysis or if you are unsure whether one is needed, please contact the Office of Coverage Analysis Administration (OCAA) at ocaa@health.ucsd.edu for guidance.

A UC San Diego-affiliated study team member must enroll the patient in Velos and update to ensure accurate billing. This individual must complete Velos training before performing these tasks.

For any Velos-related questions, please contact ctri-velos@health.ucsd.edu

Step 3: Submit a Study In-Service Request Form
The Study In-Service Request Form is a formal request to initiate a study at the designated clinic. After the clinic director reviews the study protocol, they will determine if an in-service is required. If deemed necessary, the director will reach out to coordinate and schedule the in-service accordingly. It must be submitted at least two months before the study start date (minimum of one month with prior email notification to the Clinical Operations Specialist at dmarrufo@health.ucsd.edu).

Required Documents:

• Final protocol and informed consent form
• Nursing orders for each visit
• Study checklist
• Financial chart string information (provided once the study contract is executed)

Step 4: Budget, Service Agreement and Additional Considerations:

The study team must email a completed prebuild checklist to the site's Clinic Operations team (dmarrufo@health.ucsd.edu). Once received, the clinic operations team drafts the budget using the current recharge rates and sends it to the principal investigator (PI) for approval. A Service Level Agreement (SLA), signed by the PI via DocuSign, finalizes this step. The signed SLA initiates study setup in Clinical Conductor (scheduling and billing software). Submission of the Study In-Service Form also triggers an internal ACTRI study review (safety and scientific review, if needed).

Safety and Scientific Review
To ensure patient safety and uphold research standards, all studies undergo a safety review by ACTRI’s clinic medical directors. This review assesses whether clinic staff and resources can safely support the study.

Additionally, PI-initiated and non-federally funded grant studies must undergo a scientific review, mandated by the National Center for Advancing Translational Sciences (NCATS). This review evaluates key study components, including:

• Objectives and scientific rationale
• Study design and eligibility criteria
• Endpoints, statistical analysis, and data management

The scientific review process takes approximately one month. Study teams should account for this when submitting their Study In-Service Request.

Study Team Access Requirements
Study team members are required to submit their clinic access request at least one month before the study start date. This request initiates the process for securing access to the following:

• Badge Access for Clinic Door (ACTRI@La Jolla Only)
• Badge Access for Lab (ACTRI@La Jolla Only)
• Clinical Conductor Training

Upon submission of the clinic access request, the Clinic Director will assess the required training for study staff.

• Badge Access Only (Clinic Door): No additional training is required.
• Badge Access for Coordinators (Including Lab Access): Coordinators must complete training facilitated by the Clinical Operations Specialist, clinic staff, and an ACTRI coordinator. This training will focus on efficiently navigating the clinic environment.

ACTRI staff will coordinate scheduling for all required training sessions.

Study Launch
A study is officially open for scheduling once the following are completed:

1. SLA is signed
2. Safety (and scientific, if applicable) review is passed
3. Study is built in Clinical Conductor
4. Financial chart strings are available
5. Study is built in Velos

For more detailed information on the process, please refer to the ACTRI CCR Service Request Process Overview.

ACTRI@La Jolla Clinic FAQs

1. What is the role of the metabolic kitchen in clinical research? Our metabolic kitchen is specifically designed for clinical research, allowing for precise preparation and control of study-specific diets. It is equipped with professional-grade appliances and calibrated measurement tools to ensure consistency and adherence to strict nutritional protocols. This level of control is essential for nutrition-based studies, where even slight variations in diet composition can impact research outcomes.

2. What is a BSL-2 laboratory, and why is it important? Our BSL-2 laboratory is a specialized environment equipped to handle a wide range of biological agents safely and efficiently. It features biological safety cabinets, HEPA filtration systems, and advanced ventilation controls to ensure the safe processing and analysis of biological specimens. These measures help maintain study integrity while protecting both staff and participants from potential hazards.

3. How does your facility ensure participant safety and comfort? Participant safety and comfort are our top priorities. Our facility is equipped with state-of-the-art medical technology and dedicated overnight monitoring rooms to provide continuous observation when needed. Our experienced clinical staff delivers attentive, compassionate care, ensuring that participants feel safe and supported throughout the trial. Every aspect of our facility is designed to create a secure and comfortable environment for all study participants.

4. Can my trained study coordinators perform phlebotomy or ECGs? No, all sample collection, ECGs, and other clinical procedures are performed exclusively by our highly trained clinical staff. This ensures that every procedure is carried out with the highest level of accuracy, compliance, and participant safety. By entrusting these tasks to our dedicated professionals, we maintain study integrity and uphold the rigorous standards required in clinical research.

Operations FAQs

1. Can clinical research coordinators (CRC) from Rady Children’s utilize the ACTRI@Linda Vista space? Rady Children’s staff cannot utilize this space due to credentialing and liability restrictions as the ACTRI@Linda Vista clinic operates as part of UC San Diego Health. As a result, CRCs from Rady Children’s  are not permitted to conduct coordinator activities within this facility. However, the ACTRI offers coordinator services, which can provide a coordinator counterpart to support research activities at the ACTRI@Linda Vista clinic. This ensures compliance with institutional policies while facilitating seamless coordination for clinical trials. To request ACTRI coordinator services, please select “Coordinators & Language Translation” and submit a Clinic Service Request.

2. Can I submit the Study In-Service Request without an executed contract and chart string?
   Yes. While executed contracts and chart strings are required by the end of the study setup process, they are not necessary for the initial request. This allows study teams to collaborate with the ACTRI operations team while the study contract is still being negotiated.

3. Is there a different process for requesting studies to be opened at ACTRI@La Jolla and ACTRI@Linda Vista research clinics?
   No. Both clinics follow the same workflow for study setup. This simplifies the process for studies that will utilize both sites.

4. How can the study team support the safety and scientific review process?
   The Clinic Director’s administrative team will reach out to the PI directly with any questions, comments, or issues that require clarification.

UC San Diego researchers can access clinic-specific documentation by using their @health.ucsd.edu AD credentials.

If you are unable to access the file select “Request Access” or contact ctri-clinic@health.ucsd.edu

Clinic recharge rates

Clinic access requirements and guidelines

Policy Documents

Clinic document templates

Clinic and Laboratory documentation for research

 Bernadette Cale (bcale@health.ucsd.edu) or Patty Santana (pmoraes@health.ucsd.edu)