Feasibility & Start-Up

Clinical Trials

A study is considered a clinical trial when it contemplates the controlled, clinical testing in human subjects of investigational new drugs, devices, treatments, or diagnostics, or comparisons of approved drugs, devices, treatments, or diagnostics, to assess their safety, efficacy, benefits, costs, adverse reactions, and/or outcomes. This clinical trial definition is used for calculating indirect cost (IDC) Rate for PI-initiated Clinical Trials.

In addition, a clinical trial is most often used in conjunction with obtaining new drug or device approval from the U.S. Food and Drug Administration, although they can be designed with the sole purpose of collecting and analyzing data about an approved drug or device in order to contribute to medical knowledge about the treatment of a disease or medical conditions.

PI-Initiated vs. Industry-Initiated Clinical Trials

Studies may be conducted under an industry-developed protocol or a principal investigator-developed protocol. 

For details, go to the PI-Initiated vs. Industry-Initiated Clinical Trials Quick-Reference Guide.

National Institutes of Health (NIH)

The National Institutes of Health (NIH) has recently clarified its clinical trials definition.

Go to the NIH Clinical Trials page for more information.

IRB Guidance

Consent Development

With few waivers and exceptions, researchers must obtain and document prospective consent from the research subject before initiating any screening or study procedures. Any exceptions must be reviewed and approved by the IRB beforehand. 

Consent Form Templates

When developing a consent document, you should start with the appropriate Consent, Assent and Screening Informed Consent forms for your study. With rare exceptions, new consent forms should include all applicable standards language and follow the layout of the consent form templates. These templates include required regulatory elements and UC/UCSD-required language.

Choosing a Consent Form Template

Rather than dividing the templates into biomedical and behavioral templates, they are divided into the templates used for minimal risk studies, greater than minimal risk studies or both. It is important to use the consent template that best fits the type of research you are conducting. For example, if you are conducting a study that involves the use of investigational or approved drugs, devices, diagnostics, therapeutics; or studies that may be considered interventional research, use the Biomedical greater than minimal risk consent form template.

If you are unsure which template to use, please contact the UCSD's Office of IRB Administration.

IRB Guidance for All Research Studies

Documentation of informed consent: Federal and state regulations direct that informed consent be documented, in general, with a written consent form approved in advance by the IRB and incorporating the required elements of consent. The participant or his/her legally authorized representative reads, signs and dates the consent form. The person obtaining consent also signs and dates the consent form. A signed copy of the consent form is given to the participant or, when appropriate, to his/her legally authorized representative. 

Note: No changes may be made to the form without prior approval from the IRB.

The IRB may ask for the inclusion of additional elements of consent that are recommended by the Common Rule, including:

• A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable
• Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent
• Any additional costs to the subject that may result from participation in the research
• The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
• A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject
• The approximate number of subjects involved in the study

Please contact the UCSD's Office of IRB Administration for questions or study-related issues.

Formating Guidelines

Refer to the Consent form Standards and Sample Language, for guidance on the following:

1. General Instructions about how to prepare and format the consent form
2. Section by Section Instructions about how to complete each section of the Consent Form for Greater Than Minimal Risk Studies (Biomedical Focus) template. Keep this document readily available as you prepare the consent form
3. Suggested Language for each section of the consent form template
4. Required Language for all consent forms

Special Considerations for Research Involving Tissue Storage

If you plan to save blood or tissue for future research, review the Research Involving Use and Storage of Data and/or Human Biological Specimens.

Some of the issues that may need to be addressed in the Biological Specimens consent form include:

• Whether the tissue be used for future studies or a different research purpose in the future
• Whether the tissue will remain identifiable
• What the risks of breach of confidentiality are

Regulatory requirements

The UCSD's Office of IRB Administration and the Food and Drug Administration (FDA) enforce federal regulations covering informed consent in research involving human subjects.

• Title 45-Code of Federal Regulations (CFR)-Part 46, Sections 46.116 and 46.117 apply to human research conducted or funded in whole or part by the Department of Health and Human Services (DHHS).
• Title 21 CFR-Part 50 applies to research involving products regulated by the FDA.

These regulations are applied to all human research at UCSD. The purpose of these guidelines is to assist investigators in planning the consent process and consent documents to be used in their research studies, in accord with federal regulations and HRPP standards. Additional information and examples are available at the UCSD and UCLA IRB websites.

Please contact the UCSD's Office of IRB Administration for questions and study-related issues.

Related Guidance, Tools & Templates

• Online Readability Tool
• PlainLanguage.gov (glossary of simplified words)
• NCI Dictionary of Cancer Terms
• NIH Consent Guidance
• HHS.gov Required Elements of Informed Consent

Please contact UCSD's Office of IRB Administration for questions or study related issues.  

Introduction | Coverage Analysis

Mission

To provide comprehensive coverage analysis and budgeting services for researchers and administrators to enhance their ability to achieve excellence in clinical research while adhering to University, Federal, and State guidelines to ensure billing compliance. 

What is a Coverage Analysis

A coverage analysis (CA) identifies the financial accountability for each item or service in a clinical trial.  It is an in-depth review of clinical trial documents, National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and published practice guidelines to determine the Medicare billing status of items and services that are documented in the research protocol.  As a result, services will be appropriately billed to a third party payor (e.g., Medicare, private insurance, or the patient), the trial sponsor, the study grant or other funding source.  

All studies involving human research subjects require a review for coverage analysis. A CA is required to use Medical Center resources and facilities. There are some scenarios where a CA is not required, such as studies only reviewing medical records. 

Coverage Analysis Review Objectives

1. Identify whether a study is a Qualifying Clinical Trial (QCT) that allows for billing certain study items/services to insurance pursuant to applicable laws and regulations; and
2. Determine billing designations for all patient care costs required by the study. Billing designations for study required items/services may either be: 
   • Routine Costs that may be billed to a study participant and/or their insurer(s); or
   • Study Costs for items/services that are primarily required for research purposes that should be funded by the respective study sponsor and/or internal study account.

How Routine Costs are Determined

The Centers for Medicare & Medicaid Services (CMS) provide guidance to help differentiate Routine Costs from Study Costs. National and Local Coverage Determinations, professional medical association guidance, and nationally recognized peer-reviewed publications are often utilized as resources to support Coverage Analysis billing designations.

The first step in Coverage Analysis is to determine if the study qualifies. It is a process for Principal Investigators to attest to Medicare that a clinical study meets certain Medicare qualifying criteria. When the study meets this criterion, it is a "qualifying clinical trial." This means that Medicare (and by extension, other insurance companies) will cover associated routine and expanded patient care during the clinical study. Routine care is also called "conventional care" and defines procedures/ services that would be performed absent a clinical study. Expanded care includes additional services such as clinically necessary monitoring of the effects the investigational drug or device, administration of the clinical study article (drug or device), procedures for prevention, diagnosing, and treatment of side effects or complications resulting from the patient’s participation in the clinical study (Medicare Clinical Trial Policy, NCD 310.1).

Office Of Coverage Analysis Administration | OCAA

Benefits of the Coverage Analysis

A coverage analysis ensures clinical research billing is compliant by Medicare standards, provides transparent clinical research transactions to prevent billing errors, and may be used as a tool to estimate costs and negotiate study budgets.

How is a Coverage Analysis Initiated and Who Completes the Review

A project submission to the Human Research Protection Program (HRPP) triggers an automated notification to OCAA for coverage analysis review.  OCAA comprises a team of analysts who specialize in Medicare policies and healthcare guidelines. The analysts work closely with the Principal Investigators (PI's) and their study teams to review and finalize the coverage analysis.   

Budgeting Services

OCAA now offers budgeting services for industry initiated clinical trials.  With the increasing costs and demand of clinical trials, our team offers full concierge services to execute your study budgets and to enhance your experience with the study sponsor.  We will develop a detailed budget and negotiate the figures with the sponsor to ensure the sponsor covers the full cost of conducting the study at UCSD.

What You Can Expect from Our Budgeting Service

Customer Service: We keep the PI apprised of the budget at all stages of the process.  We offer in-person meetings to review our budgets to ensure the PI’s input and budget goals are incorporated in our budgets.  Each budget will be assigned an experienced analyst that will be your main point of contact should you need any clarification.  Our analysts will be available via phone, email or in-person meetings to ensure the budget meets your needs.

Comprehensive Reviews: We capture all of the costs of conducting the clinical trial.  In our budget development process we identify and budget for all costs from the beginning with study start-up costs all the way through to study close out costs, direct and indirect costs, per patient costs, personnel costs, invoice costs, supplies/equipment and facility costs, and central office fees.

Competitive Timelines: Our review and first draft of the budget will be sent out to the sponsor within 4 - 6 weeks of receiving the budget request through ePD.  

Quality: After the study has started, we will follow up with your team for feedback.  In the event the budget provided to you does not capture the appropriate costs we will renegotiate the budget with the sponsor.   

What is the Cost of the Budgeting Service

For NEW studies: $3,250 (Inclusive of OH)

For AMENDMENTS to existing studies: $1,300 (Inclusive of OH)

How to Request Our Budgeting Service

Submit requests through the online form

Contact Us

For general inquiries please contact us at: ocaa@ucsd.edu or 858-534-4761

Drug/Device Coverage Requirements

Device study Coverage Requirements

Investigators participating in an Investigational Device Exemption (IDE) Study that plans to request reimbursement for study procedures and materials from Medicare or third-party payers must ensure the following:

1. CMS IDE study coverage has been approved by CMS or local Medicare contractor
   • CMS approval of coverage for Category A devices applies to  the routine care items and services required by the study, but not the experimental device
   • CMS approval of coverage for Category B devices allows for coverage of the routine care items and services required by the study as well as the investigational device.
2. Other devices that may be covered by Medicare include
   1. Premarket Approval (PMA)
   2. Humanitarian Device Exemption (HDE)
   3. 510(k) approved devices
   4. IRB-approved Non-Significant Risk (NSR) device

Drugs Study Coverage Requirements

Medicare will cover the cost of QCTs that are conducted under an Investigation New Drug (IND) reviewed by the FDA. IND exempt studies are deemed automatically qualified for coverage until further qualifying criteria are available. Once the qualifying criteria are available, the Principal Investigators of the study must certify that the study meets all qualifying criteria for Medicare coverage of routine costs. The new qualification will apply to the prospective study charges generated.

Please click here for more contact information.

Data Management Guidance

Data Management Guidance

Data management plans (DMPs) encourage researchers to think about how they will responsibly handle the data they collect, and are required by many funders. The National Science Foundation (NSF) requires that all grant proposals be accompanied by a data management plan. Other federal funding agencies have similar requirements or will have soon. This guidance will serve as a starting point to guide researchers through the data life cycle process with available tools either on campus or through the California Digital Library (CDL).

• Data Management General Guidance
• UCSD Library Data Management Best Practices
• CDL Examples of Data Management Plans
• NSF Data Management Plan Policy

Researchers who are required to submit a data management plan as part of a funding proposal may wish to consult the DMPTool. The UCSD Research Data Curation Program can provide additional guidance on managing and sharing research data. 

You may also find useful information from the UCLA Library Data Management for the Sciences, which also provides a guide to best practices for management of research data, including links to data services and selected repositories sorted by broad subject areas.

Data Storage Information

• UCSD Library Data Storage, Backup, Repositories and Sharing

UCSD Guidance on the proper handling of sensitive data can be found in the UCSD Guidelines for Handling Sensitive Data. 

Guidance from UCSD HRPP: 

• UCSD Guidance on HIPAA  Privacy Rule Information 
• SOPP Privacy and Confidentiality of Research Records
• SOPP Confidentiality of Collected Specimens or Data

Accrual to Clinical Trials (ACT)

The ACT Network is a real-time, open access platform allowing researchers to explore and validate feasibility for clinical studies

UC San Diego Altman Clinical and Translational Research Institute (ACTRI) is pleased to announce that it has partnered with the Accrual to Clinical Trials (ACT) Network to bring real-time cohort exploration and discovery to its researchers. Initially developed as UCReX, ACT has evolved into a network that incorporates >120 million lives, spearheaded by UCSD, University of Pittsburgh, Harvard and UT Southwestern.

ACT was developed by members of the Clinical and Translational Science Awards (CTSA) Program consortium to enable cohort discovery using a web interface in a HIPAA-compliant manner, without requiring study-specific IRB approval. It offers open-access to a national network of leading academic medical research centers and generates aggregate patient count data from an investigator's real-time, iterative searches. Using ACT, UC San Diego Health researchers can explore patient populations, confirm and demonstrate study feasibility, and identify potential partners for multi-site studies. ACTRI is one of the first 21 CTSA hubs across the country to launch the ACT Network. Now linking 48 hubs and a Trial Innovation Network (TIN) resource, the ACT hubs share ontologies, governance and data use agreements. UCSD has performed cohort discovery searches for the TIN. Led by UCSD with University of Pittsburgh, UT Southwestern and Harvard, the NCATS ACT network is an important tool for research design to assure studies are performed at the appropriate hubs.

ACT is available to all UC San Diego Health researchers at no charge, but registration is required.

Register for ACT

More information about ACT

Data Management  Tools and Resources

Data Collection Tools

• Citation Management
• Research Software Licensing
• Case Report Form (CRF) resource from NINDS

Data Processing Tools

Clinical Trials and Sample Repositories

Velos eResearch is an integrated software system for managing clinical trials. The software links to the UCSD Health's Epic Electronic Medical Record System to provide improved information and integration for clinical research projects. One module within this platform, called eSample, will track biological samples and link them to the Electronic Health Record. A robust support team assists investigators in implementing their protocols, study budgets, and calendars. Velos eResearch is a web-based system that supports

• Creation of budgets
• Creation of protocols with calendars
• Scheduling of subjects
• Electronic case report forms
• Tracking visits and events
• Creation of invoices
• Reporting

Request Velos Access under the Biomedical Informatics tab on the BMI Request Form.

Simple Studies and Surveys

• REDCap (Research Electronic Data Capture) is a secure, web-based application for building and managing online surveys and databases.
• With REDCap's streamlined process for rapidly developing projects, an investigator may create and design projects using 1) the online method from his or her web browser and the Online Designer; and/or 2) the offline method by constructing a 'data dictionary' template file in Microsoft Excel, which can be later uploaded into REDCap. Both surveys and databases (or a mixture of the two) can be built using these methods.
• REDCap provides automated export procedures for seamless data downloads to Excel and common statistical packages (SPSS, SAS, Stata, R), as well as a built-in project calendar, a scheduling module, ad hoc reporting tools, and advanced features, such as branching logic, file uploading, and calculated fields.

Request REDCap Access under the Biomedical Informatics tab on the BMI Request Form.

Electronic Health Record Queries

The Clinical Data Warehouse for Research (CDWR) pulls a subset of the data from the Electronic Health Record system and allows investigators to query patient information in a HIPAA-compliant manner. The data are primarily drawn from UC San Diego Medical Center's Clinical Data Warehouse, which contains data from more than 2.4 million patients collected during the last two decades, and represents 5.8 million outpatient visits, over 130,000 Emergency Department visits, and over 1.8 million inpatient admissions.

Patient Information Extract Service (PIES) in electronic health records is a service that identifies specific patients, and extracts identified, de-identified, or limited patient-level datasets from electronic medical for clinical research projects. An approval by the Institutional Review Board (IRB) is required for extracting identified and limited datasets. Our support team will execute queries on CDWR and return results to users, as approved by their IRB protocols. For more information, submit a BMI Request Form. 

If only counts of patients matching certain criteria are required, please use the Accrual to Clinical Trials tool. To request an account, please fill out a Service Request Form.

NOTICE: If you plan on collecting data for the purpose of human subjects research, your project must be reviewed and approved by your Institutional Review Board.

Other Data Management Resources

• Data Management for Clinical Research Online Course.  Coursera offers FREE online courses in a variety of subjects and specialties from 62 leading Universities and Colleges worldwide. UCLA is one of the teaching institutions, and new Universities are signing up every month. You do not receive a grade for the class, but if you participate and successfully complete all assignments and tests then you receive a certificate upon completion. All you have to do is go to the site, create a login, browse offered courses and sign up. When the course is about to begin you will receive an email with all the details. This course is called Data Management for Clinical Research, and it is being offered by Vanderbilt University (the creators of REDCap). Here is the link to the class details: https://www.coursera.org/course/datamanagement.
• Merritt is a new cost-effective repository service from the University of California Curation Center (UC3) that lets the UC community manage, archive, and share its valuable digital content.   For more information, see merritt.cdlib.org or contact UC3.
• The University of California Curation Center (UC3) is a creative partnership bringing together the expertise and resources of the California Digital Library (CDL), the ten UC campuses, and the broader international curation community to foster collaborative analysis, projects, and solutions to ensure the long-term viability and usability of curated digital content. 

Feasibility Guidance & Scientific Review

Protocol Development

Clinical Trial Protocol Development

Every clinical investigation begins with the development of a clinical protocol. A research protocol is a document that describes how a clinical trial will be conducted (background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project), and the methods used to ensure the safety of the trial subjects and integrity of the data collected.

• Title Page (General Information)
• Background Information
• Objectives/Purpose
• Study Design
• Selection and Exclusion of Subjects
• Treatment of Subjects
• Assessment of Efficacy
• Assessment of Safety
• Adverse Events
• Discontinuation of the Study
• Statistics
• Quality Control and Assurance
• Ethics
• Data and Safety Monitoring Plan
• Data handling and Recordkeeping
• Publication Policy
• Project Timetable/Flowchart
• References
• Supplements/Appendices

The NIH provides many resources for protocol development to assist investigators in writing and developing clinical research protocols that are in compliance with regulatory/GCP requirements. Some NIH institutes have a mandatory requirement for using their protocol template.

Study Design consultation and assistance are available at UCSD. Please see the ACTRI Regulatory Support unit for more information.

Please review the ICH-GCP Protocol Checklistfor additional guidance.

Sample Protocol Templates and Resources:

• UCSD Protocol Templates
• NIDCR-Interventional Protocol Template (Drug, Device, Behavioral)
• NIAID Clinical Research Toolkit- Clinical Trials Protocol Templates
• NCI-CTEP Protocol Development Templates and Guidelines
• NINDS Glossary of Clinical Research Terms

Study Management Tools

What is 21 CFR Part 11?

21 CFR Part 11 outlines the federal requirements that help to ensure that electronic records are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. 

Does 21 CFR Part 11 apply to me?

The first step in becoming compliant with the regulations is to determine whether or not you are required to be compliant. The following questions can help lead to the determination:

1. Is your clinical trial conducted under an approved IND?
2. Is your clinical trial conducted under an approved IDE?
3. Does your grant specify that your computer systems must comply with 21 CFR Part 11 or similar requirements?

If you answered yes to any of these questions, your electronic systems of record that are being used to meet predicate rules are required to comply with 21 CFR Part 11.

The second step of the process is to identify the computer systems you are using in your clinical trial.

Addressing the following can help identify all of the computer systems associated with your trial:

1. Are you using an outside laboratory for laboratory analysis?
2. If so, is the laboratory accredited?
   • If the laboratory is not accredited, assurance should be required in regard to the data quality
3. Are you using a UCSD laboratory for analysis?
   • If yes, the instruments being used should be compliant
4. Are you entering data directly into an electronic database?
   • If yes, the database must be compliant
5. Are you entering data (from paper) into an electronic database?
   • If yes, then the database must be compliant (as discussed in the Scope of Guidance for Industry: Computerized Systems Used in Clinical Trials)
6. Are you using electronic logs?
   • If yes, then the logs must be compliant

Please Note: Not validating your electronic system(s) of record may result in regulatory citations. If you have any questions or concerns about your system, reach out to the ACTRI Center for Clinical Research.

What software features are necessary to be 21 CFR Part 11 compliant?

Security

• Define which individuals shall have access to the software - a current list shall always be available
• Define what the user roles are for the software (i.e. administrator, data entry, approver, etc.) and what each role can do
• Access to software shall require each user to have a unique username and password
• A defined number of incorrect login attempts shall lock the user from the software
• A defined time of inactivity shall lock the software for a given user

Audit Trails

An audit trail shall be implemented that allows a means to reconstruct data modification.

The audit trail shall include: the name of the user that made the entry, what was changed (not obscuring the original value), the date and time of change and the reason for change.

Electronic Signatures/Digital Signatures

If electronic signatures will be used, they must include the following:

1. Name of signer
2. Time and Date of signature
3. Meaning of signature

Note: An electronic signature consists of two components: id code (username) and password.  This is different than the initial login to the software.

Reporting

Users must have the ability to obtain meaningful data from the software.

Software Workflow

The software shall be designed in such a way that a logical process workflow is incorporated (i.e. you are unable to approve until all required pieces are completed).

Record Protection

Data must be backed up on a regular basis

Standard Operating Procedures

1. Standard Operating Procedures ensure the consistent use of the software
2. Procedures should be developed on how the software will be used for a specific task
3. Procedures shall also be developed for administrative functions of the software: how to add users, etc.
4. Procedures should also be developed for activities that happen outside of the software in order to ensure the most accurate data

Training

Training should be documented to verify that only trained individuals are using the software.

Validation

A quality validation methodology shall be used to ensure the system (software, people, etc) is performing as intended.  It is important to understand that you are validating a SYSTEM and not just the software.

If you have any questions or concerns about your system, reach out to the ACTRI Center for Clinical Research.

Information and Tools for Validating a System

Validation Plan

The Validation Plan is a document that outlines the process that will be used for validating a specific system. The plan will discuss the specific risk of the system and outline the documents that will be written (how many SOPs).

Functional Requirements

These documents will outline the specific requirements of a system. Typical items covered in a Functional Requirements documents are: User Roles, User Access, Process Workflow and 21 CFR Part 11 Requirements (Audit Trail, Electronic Signature). 

These documents are crucial to a successful system validation. Requirements must be written concisely represented. The example below uses content for an Audit Log:

Audit Log report

•  User that made the change
•  Reason for change
•  Previous Value
•  New Value
•  Date/Time of Change

Server Requirements

This document will outline the necessary hardware and architecture for a system.

Design/Configuration Document

A Design/Configuration Document will outline how the specific software was designed and include any specific configuration. 

Installation Qualification

Installation Qualification verifies Server Requirements were met and also verifies the Design/Configuration of the software. 

Operational/Performance Qualification

This document "tests" the Functional Requirements document. It will include challenge testing. It is important to ensure all error messages display as necessary. This testing also ensures the workflow is as intended.

Final Validation Report

The Final Validation Report summarizes the testing (including deviations) and is used to release the software for production use. 

Change Control

After validation has been completed, all changes to the system must be maintained through a change control process. Here are example templates of information necessary for a compliant change control process:

• Preapproval
• Closure

More references for validating systems and 21 CFR Part 11

• Inspections of Sponsors, CROs and Monitors
• Guidance for Industry Computerized Systems Used in Clinical Investigations
• General Principles of Software Validation; Final Guidance for Industry and FDA Staff

If you have any questions or concerns about your system, reach out to the ACTRI Center for Clinical Research.

Related Tools, Guidance and Templates

• 21 CFR Part 11
• Scope of Guidance for Industry: Computerized Systems Used in Clinical Trials)
• Validation Plan Example template
• Functional Requirements Example template
• Design/Configuration Document Example template
• Installation Qualification Example template
• Operational/Performance Qualification Example template
• Final Validation Report Example template
• Change Control Preapproval
• Change Control Closure
• Inspections of Sponsors, CROs and Monitors
• Guidance for Industry Computerized Systems Used in Clinical Investigations
• General Principles of Software Validation; Final Guidance for Industry and FDA Staff

If you have any questions or concerns about your system, reach out to the ACTRI Center for Clinical Research.

The UC San Diego Health Clinical Research Billing (CRB) department is responsible for assuring that charges for research participants are reviewed for routing to the appropriate responsible party: participant insurance or research study.

Click here to learn more.

The Sanford Stem Cell Institute is a global hub for stem cell science and innovation in space, advancing stem cell research through collaborative, multi-disciplinary interactions using state-of-the art core research facilities for stem cell translational medicine, and an extensive Alpha Stem Cell Clinic Network across the state of California to conduct clinical trials of promising new regenerative medicine. Learn more about the Sanford Stem Cell Institute here.

Contact

Sanford Stem Cell Institute at
Sanford Consortium for Regenerative Medicine

Location:
2880 Torrey Pines Scenic Drive 
La Jolla, CA 92037
Mailing:
9500 Gilman Drive #0695
La Jolla, CA 92093-0695
Email: 
sanfordstemcell@ucsd.edu

Sanford Stem Cell Institute at
Advanced Cell Therapy Laboratory (ACTL)

Location:
10300 Campus Point Drive, Suite 1249
San Diego, CA 92121
Mailing:
9500 Gilman Drive #0695
La Jolla, CA 92093-0695
Email: 
actl@ucsd.edu

Sanford Stem Cell Institute at
Jacobs Medical Center

Location:
9300 Campus Point Drive
La Jolla, CA 92037
Mailing:
9500 Gilman Drive #0695
La Jolla, CA 92093-0695 
Email: 
alphastemcellclinic@ucsd.edu

Sanford Stem Cell Institute at
Koman Family Outpatient Pavilion

Location:
9400 Campus Point Drive
La Jolla, CA 92037
Mailing:
9500 Gilman Drive #7312
La Jolla, CA 92093-7312 
Email: 
alphastemcellclinic@ucsd.edu

Sanford Stem Cell Institute at
Altman Clinical and Translational Institute (ACTRI)

Location:
9452 Medical Center Drive, 3rd Floor
La Jolla, CA 92037
Mailing:
9500 Gilman Drive #0695
La Jolla, CA 92093-0695 
Email: 
alphastemcellclinic@ucsd.edu