Section I. Introduction and Purpose of the Guide to Clinical Research at USC

Dear Research Colleagues at the Keck School of Medicine,

On behalf of the SC Clinical and Translational Science Institute, we are excited to provide this Guide to Clinical Research to help introduce and describe the clinical research processes here at USC. 

The purpose of this Guide and the corresponding ancillary documents is to provide a clear, user-friendly overview of conducting human studies research at USC and the Keck School of Medicine. The audience for these materials is investigators and research personnel at USC and the Keck School of Medicine.

If you are new to USC, you can use the New Study Navigation Tool to help you get started. This tool provides information about which offices you’ll need to engage with in order to activate your study. Sections II and III provide an overview to help you activate your clinical study at USC.  

In addition, the SC CTSI provides free research navigation services to all faculty, staff, and students. If you have any questions, contact Clinical Research Support at 323-442-CTSA or crs@sc-ctsi.org.
Finally, this document is dynamic and meant to be updated regularly as processes change and new information becomes available. Updates and suggestions for content can be emailed to: crs@sc-ctsi.org

Our hope is that you will find this guidance useful at every stage of the research process, from study start-up to closeout. We thank you for your commitment to our institution and for conducting groundbreaking, important clinical research that has real-world impact for our local communities.

Wishing you and your team the best of luck in all of your research endeavors. Fight on!

Sincerely,

April W. Armstrong, M.D., M.P.H. 
Associate Dean for Clinical Research 
Keck School of Medicine of USC

Lily Jara, B.S.
Clinical Research Coordinator Supervisor 
SC Clinical and Translational Science Institute


Section II. Quick Start for Activating Non-Industry Funded (e.g., Federally Funded and Foundation Funded) Clinical Studies at USC

For a general overview of the clinical research initiation process for new or junior investigators, see the figure below. Note, this Guide to Clinical Research will elaborate on each aspect of this figure.

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A non-industry study receives funding from federal agencies such as the National Institutes of Health (NIH), Department of Health and Human Services (HHS), Department of Defense (DOD), and non-profit foundations. This process map below provides the necessary steps to activating a non-industry funded clinical study “at-a-glance.” 

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For PIs applying for non-industry funding, the process is as follows:

●        PI submits the proposal and initial budget for internal review through Kuali Coeus (KC) (through June 2021). They must attach the Scope of Work (SOW), preliminary budget, budget justification, and any other documents required by the sponsor.

●        In parallel, the PI may seek out advice on budget preparation from the CTSI budget specialist Joanne Pak.

●        The PI then submits the proposal in KC, and it is routed to the Department for approval if the Department is within the Keck School of Medicine (KSOM).

●       If the proposal and preliminary budget are approved by the Department within KSOM, the Department of Contracts and Grants (DCG) reviews and approves the proposal. If changes are requested, the proposal is routed back to the PI to make the necessary changes. If changes are not required, the PI submits to the sponsor, and the sponsor assigns a funding score.

●        If the proposal receives a fundable score, a confidential disclosure agreement (CDA) may be required by the sponsoring organization, and will be executed between the sponsor and USC. Sometimes a CDA is referred to as a non-disclosure agreement (NDA), though the function is the same. CDAs are typically not required for federally-funded studies. In the case that a CDA is required, the funding agency will let the PI and/or study staff know that a CDA must be executed before any study-specific information can be released.

Resources for proposal preparation, including what proposal guidelines, budget development guidelines, and more, can be found here

Budget Preparation Support: For guidance on preparation of study budgets for non-industry funded human studies, especially for federal grant applications, contact CTSI budget specialist Joanne Pak at 323-442‑7278, or by email at Joanne.Pak@med.usc.edu

In the event that a CDA is required, the funding agency will not release the protocol and/or study related information to the PI until the CDA or NDA is executed.

The CDA/NDA may be a one-way (unilateral) agreement that requires only the receiving party to maintain secrecy. For example, a funding agency may provide information to a PI so he/she can determine if he or she would like to participate in a study. The CDA or clause may also be a two-way or mutual agreement in which both parties exchange confidential information and are obligated to maintain secrecy. Regardless of whether the agreement is unilateral or mutual, information provided to USC under the agreement cannot be disclosed to a third party or may be limited to persons within USC on a need-to-know basis.

Access to confidential information must be limited to personnel who need the information to perform the study, work with patients, or work with ancillary groups. The information should never be shared outside of USC, and should only be shared with others at USC if they need to know the information, and if they are informed that the information is confidential. PIs and CRCs alike are responsible for protecting confidential information. Consult USC’s Guide to Confidentiality for further information.

Regarding the process for executing the CDA, the PI or member of study team submits the CDA via KC for non-industry sponsored clinical studies. During the KC routing and approvals process, the PI will be required to approve the CDA submission. For lead units in KSOM, it must also be approved by the department/division designee and the School designee. DCG will then review and negotiates the CDA with the sponsor. Upon agreement, DCG determines if PI signature is required. If required, DCG routes the CDA for signature. After the PI signs, DCG executes and distributes the CDA. 

USC Department of Contracts and Grants:

213-740-7762; List of DCG staff and contact information

After the CDA is executed (when deemed necessary by the funding agency), the budgeting process begins. For non-industry sponsored studies, DCG can be involved in the proposal submission, award review, and approvals process. However, in many cases, the PI is responsible for the submission of the proposal to the funding organization. If the study is NIH-funded, the DCG (rather than the PI) must submit to the funding agency. For other funding organizations and for foundation funding, the DCG reviews the application in KC. Once DCG approves the application within KC, DCG alerts the PI and study team that they are permitted to proceed with the submission process. 

Contract and Budgeting Process Guidance Map
This guidance map below provides information about which office handles which aspects of the budgeting and contracting process based on two metrics: the study’s funding source, and whether or not the study will use hospital resources, such as clinic rooms, pathology, etc. 

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1. Non-Industry Contracting Process 

For federally funded and non-industry funded studies, DCG may be responsible for reviewing, approving, and submitting the proposal to extramural sponsors. See Section II, D. Contract and Budgeting Process for an explanation of when DCG submits to the funding agency versus when the PI submits to the funding agency. DCG also negotiates and accepts awards on behalf of USC, executes subcontracts, coordinates pre- and post-award actions, and more. DCG uses KC for proposal and award management.

If the funding source is non-industry, DCG will assist with contract negotiation, budget, and submission via KC PreAward. If the study uses health system resources, such as procedures done in the Keck Medical Center, DCG will assist with contract negotiation, and submission via KC PreAward. CTO will provide pricing for clinical activities and procedures, as well as perform the Medicare Coverage Analysis (MCA). The study’s Department must manage budget development.

2.  Budgeting Process 

Following the proposal initiation, submission process, and the CDA process (when the funding agency deems it necessary), the CTO will begin conducting a Medicare Coverage Analysis (MCA). An MCA is a requirement for all clinical studies in which there are tests, procedures and interventions that are associated with research, and an MCA is required for studies that use hospital resources. Examples of hospital resources include use of clinic rooms, pathology services, and more. MCAs are performed for all clinical research studies, irrespective of their funding source. The MCA must be completed for such studies prior to contracting and prior to enrollment of study participants. During an MCA, the CTO coverage analyst will review the protocol for any clinical services to determine which can be reimbursed by Medicare or as part of Standard of Care (SOC). Following the completion of an MCA, the PI will receive a study-specific billing summary that itemizes all clinical services to be provided to the patient as part of the research, and the analyst will specify which services should be billed to the study sponsor, and which can be billed to Medicare. As a general rule, clinical services that are strictly part of the research study will be billed to the sponsor, whereas services that are part of the standard of care that the patient would receive anyway are billed to Medicare or the patient’s insurance. 

Medicare Coverage Analysis Process:

● Once the internal OnCore submission is completed, CTO conducts coverage analysis 
● PI should review and approve coverage analysis determination showing services and activities that will be paid by sponsor, insurer, or other USC account 
● Once the study is activated by CTO’s budget specialist in OnCore, the study team must conduct clinical trial in accordance with approved protocol and the Clinical Trial Agreement (CTA). (The study team cannot begin the study until formally notified by the IRB that the study can begin.)

For non-industry funded studies, the award is forwarded to the Sponsored Projects Accounting (SPA) group, and they set up the account in KC. The account number is then inputted to OnCore. After the appropriate documents are processed, the study can proceed to the next step, which involves IRB approvals. (The budgeting/contractual and IRB processes may occur simultaneously when allowed by the funding agency).

1. USC Clinical Trials Unit (CTU)
The USC Clinical Trials Unit (CTU) provides the infrastructure, resources, and support to conduct human studies, with a focus on early phase and complex mechanistic trials. CTU can assist study teams with accommodating patient visits for high intensity trials that involve serial blood draws, infusions, and monitoring. The CTU also has trained clinical staff like research nurses, phlebotomists, radiology technicians, and more. The staff is highly experienced in collecting and processing PK and PD samples in a timely and efficient manner.

CTU: Yolanda Gutierrez, Assistant Director for Clinical Research Operations; 323-865-3056; cerda@med.usc.edu or ctu@sc-ctsi.org

The CTU also offers a specimen-processing center that offers a variety of services and serves as a one-stop unit for processing, storing, and shipping research samples collected from research patients. The USC CTU has the capability to provide X-ray absorptiometry (DEXA) for body composition or bone densitometry studies. The CTU also provides specimen collection and processing services that may include blood, saliva, sputum, urine, stool, hair follicles and other types of specimens. In addition, the CTU Processing Center can perform specialized processing for studies in which the assays are run in the investigator’s lab, research core lab, or sponsor’s central lab. Specimen processing may include the following: Serum/plasma separation, buffy coat separation, custom labeling, centrifuging, aliquoting, blood smear, PBMC separation; assistance with shipping & handling (ambient, refrigerated, dry ice). To learn about the CTU’s full capabilities, click here.

CTU Laboratory: Lilit Baronikian, CTU Lab Supervisor, 323-865-3379 (office) or 818-642-4838 (cell), yegiyant@med.usc

2. USC Investigational Drug Services (IDS) Pharmacy
IDS Pharmacy supports human studies involving investigational products and supports safety and care for research participants in both the inpatient and outpatient areas. IDS Pharmacy integrates its activities with the clinical, safety, informatics, administrative, and drug distribution systems of the hospitals and clinics to optimize investigational product therapy for patients. IDS Pharmacy assists with regulatory compliance, integrity of blinding and randomization, dispensing of investigational products, temperature monitoring, and more. 
Coordinating with the IDS Pharmacy early on is crucial to ensuring that they can accommodate requests for creating, storing, and dispensing the study drug, even during the site qualification phase. If the study requires the use of an investigational product, the PI will need to involve the IDS Pharmacy.
You should contact the IDS Pharmacy via e-mail as soon as you have identified that your study involves investigational product (ideally before IRB submission). They will respond within 1-2 business days and draft a scope of service agreement that details your study’s pharmacy fees depending on whether it is industry-sponsored, government-sponsored or investigator initiated.  
It may be necessary to set up a site qualification visit. If so, the study team should contact, inform them of the items to be assessed during the site qualification visit, and work with them to prepare accordingly. The study team should provide additional information to the IDS Pharmacy that will help them determine how feasible it will be for them to take on the study. For example, providing information about the estimated number and size of the study kits or investigational drug that needs to be stored, how frequently they will be shipped, and how the drug will need to be dispensed and stored will be helpful to the IDS team. 
If on-campus pharmacies are unable to accommodate, it will become necessary to explore other options such as third-party pharmacies near HSC campus to see if they can assist with storing and dispensing the drug. There are local third-party compounding pharmacies that can assist with dispensing drugs, and other compounding pharmacies around the U.S. that can assist with creating drugs and placebos. Their fees will depend on the details of the study. 

IDS: PIs should contact the IDS Pharmacist (idspharmacy@med.usc.edu, 323-865-3538) to determine study feasibility and budget requirements. Depending on the protocol, pharmacy services may be conducted at the IDS Pharmacy or transferred to satellite sites (such as Keck Hospital of USC or Norris Cancer Hospital).

Other Pharmacies: For a list of possible pharmacy options beyond those at HSC, contact the SC CTSI CRS group at crs@sc-ctsi.org

3. Radiology & Imaging
Radiology and imaging services are available at the Norris Cancer Center and at Keck Hospital (Healthcare Consultation Center II and the PET Center in Healthcare Consultation Center I). Patients recruited from LAC+USC may be imaged at HCC2 or the PET center only if funding is available. The process can be initiated while the study is under review by the IRB. However, no research scans may be scheduled until the study has final IRB approval, which is contingent on RSC approval. In addition, research scans can’t be scheduled until ROF is available and Radiology Scan Request form (if applicable) is completed. Radiology research imaging charges are determined by the coverage analysis performed by the CTO. Please note there is a charge by the Department of Radiology for completion of RECIST tumor flow sheet form by a radiologist. Please make sure CTO is aware and prepares your budget accordingly.

Radiology: The coordinator will send an email to Bhushan Desai (bhushand@usc.edu; 323-865-9949) or contact the Department of Radiology at 323-442-8541, outlining the imaging requirements for the study and provide any additional materials (i.e., imaging manual). Imaging can be requested using the Research Order From created by the Clinical Trials Office. 

Imaging
Center for Image Acquisition
The Center for Image Acquisition, part of the USC Mark and Mary Stevens Neuroimaging and Informatics Institute, houses MRI equipment used for neuroimaging. The Center has other equipment to help PIs conduct scans that ensure the comfort for participants. Click here for a full list of equipment and capabilities.
CRCs can schedule appointments with the Center by creating an account under the “For Investigators” tab. The following information will be needed for the application: project name, proposal number, PI name, anticipated start date, copy of IRB approval letter, copy of study budget showing scan costs. Once the application is approved, login credentials will be provided, and users will be able to schedule online. Investigators preparing budgets for new proposals should contact the center to obtain the latest rates for scans and other services. Please allow at least 2 weeks for rate requests to be approved. 

CIA: Direct any questions to CIA@ini.usc.edu.

Molecular Imaging Center – Radiochemistry/Cyclotron Labs
The Molecular Imaging Center (MIC) is a comprehensive imaging program focused on the development of various types of PET tracers used for imaging disease. The facility includes a Cyclotron GMP facility, PET radiochemistry laboratories, access to small animal imaging, and access to clinical PET/CT imaging facilities.
PIs interested in utilizing these services should contact Peter S. Conti, MD, PhD to set up an initial meeting to discuss the feasibility of the study, the radiotracer availability/preparation and clinical trial enrollment. Clinical imaging studies will be performed under pre-IND, IND or approved drug protocols at HCC-I. Opportunities for early-phase clinical trials and multi-center trials are available at MIC including existing trials in the following areas:

Oncology:
● Breast Cancer
● Prostate Cancer

Neurodegenerative Disease:
● Alzheimer’s Disease
● Parkinson’s Disease

Cardiovascular Disease:
● Cardiac Ischemia

MIC: Peter S. Conti, MD, PhD. 323-442-3858 / peter.conti@med.usc.edu and copy miclab@usc.edu.

4. Pathology
The point of entry for all human biospecimen procurement needs is the Translational Pathology Core Facility (TPCF) of the USC/Norris Comprehensive Cancer Center, including whether for clinical trials, non‐interventional translational research studies, basic research studies, and whether cancer‐related or not. In this capacity, the TPCF works closely with the hospital‐based employees of the LAC+USC Medical Center and the Keck Medical Center to facilitate the process of research tissue acquisition and processing and to insure compliance with federal, state, and local hospital regulations. The activities of the TPCF are supported by chargebacks to the study PI. Any investigator may request services from the TPCF, and Cancer Center members receive services at a discounted rate. Specimens can be obtained by USC investigators with IRB approved, funded studies with a valid Lab Agreement.

For all research studies requiring the use of human biospecimens, including both clinical trials and non‐interventional (non‐clinical trial) translational research and basic research studies, investigators must submit the Laboratory Agreement Request Form in order to obtain approval to procure biospecimens. The Laboratory Agreement Request Form must only be submitted after funding and IRB approval have been obtained, Once the Lab Agreement is approved, the investigator will meet with Pathology to arrange the implementation of the biospecimen procurement, processing, and distribution required by the protocol.
 
For clinical trials, once the trial is opened, two additional forms will enable investigators to request procurement from individual patients: Request for Formalin Fixed Paraffin Embeded (FFPE) Slides/Tissue Blocks and/or Request for Fresh/Frozen Tissues can be obtained from and submitted to Ms. Chen. 

Types of human biospecimens available for research: 
1) Formalin-fixed, paraffin-embedded (FFPE) tissues: 
All tissues taken during clinical care are saved for a period of time in the hospital archives in the form of FFPE blocks. These can be used for research purposes provided appropriate consent and IRB approval have been obtained. At Keck Medical Center, these tissues are stored indefinitely. At LAC+USC, the FFPE tissues are stored in the hospital archives for 10 years, at which point they are donated to the Population Based Tissue Arm of the TPCF. TPCF personnel can assist with procurement and sampling (e.g., sectioning, coring) of FFPE blocks in the hospital archives. 
2) Fresh, fresh/frozen, and fluid specimens (e.g., whole blood, serum, plasma, buffy coat, and urine):
Fresh, fresh/frozen and fluid biospecimens can be collected prospectively for IRB approved, funded studies with a valid Lab Agreement and patient Informed Consent. Typically, both tumor and matched normal tissue are collected immediately after explanation under the supervision of the service pathologist/PA. The TPCF personnel will assist with the immediate processing and storage of the specimens, banking, tracking, distribution, and processing of specimens required for analysis.

Pathology: List of contacts for the service/core, click here or email Sue Ellen Martin, MD, PhD, director; sue.martin@med.usc.edu

In order to initiate the IRB application submission process, the study application and protocol will need to be submitted to iStar. All co-PIs must agree to participate in the study before the PI can submit the application to the IRB for review. The application needs to be approved by the PI or co-PI in order to finalize submission, after which the Division/Departmental must approve the application in order to route the study for IRB review. IRB Staff are then assigned to conduct a cursory review.

All investigator-initiated non-cancer clinical trials that have not undergone prior scientific review by a qualified scientific body are automatically routed to the SC CTSI Clinical Research Support Scientific Protocol Review Committee to undergo scientific and feasibility review as a part of the IRB review process. More information regarding the Scientific Review process can be found in Section V. IRB Approvals Process, subsection E.

After scientific review is complete or not deemed necessary, the IRB administrator categorizes the study as Full Board, Expedited, or Exempt. If the study is subject to Full Board Review, as is true for most clinical trials, the study will be assigned to a Committee Review. During the Committee Review Process, the board members will conduct independent reviews, followed by a Committee Meeting during which the study protocol and corresponding risks are discussed.

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If the IRB has questions or issues with the protocol, contingencies will be given to the PI and study team. A contingency is an item from the IRB that must be addressed in the next submission before the IRB can approve the study. When responding to the IRB, it is best to err on the side of caution and explain the decision-making and study processes in more detail rather than less so that the analyst and/or board can understand the rationale without having to ask for clarifications from the PI and study staff. Once all contingencies have been adequately addressed, the IRB will approve the protocol within iStar. The approval comes in the form of an IRB approval letter uploaded to iStar that outlines what was approved. However, it is important to note that IRB approval does not necessarily mean that the study can begin, especially in the case of industry-sponsored trials. Once the contract is finalized, the the IRB will re-issue an approval, indicating that the study can begin. At this time, the IRB will also release the approved and stamped ICFs.

Upon release, the IRB approval letter and ICF is approved for one year from the release date. If the study plans to continue past one year, continuing review must be completed. More information about continuing review is found in the Appendix. If the study closes after one year, more information about that process is also found in the Appendix. More information on the USC IRB and the Office for the Protection of Research Subjects (OPRS) can be found here.

IRB: 323-442-0114; IRB@usc.edu.


Section III. Quick Start for Activating Industry-Funded Clinical Studies at USC

For a general overview of the clinical research initiation process for new or junior investigators, see the figure below. Note, this Guide to Clinical Research will elaborate on each aspect of this figure.

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Industry-sponsored studies are funded by pharma or other for-profit entities and USC receives a protocol to carry out, which was written by the for-profit entity. This process map provides the necessary steps to activating an industry-funded clinical study “at-a-glance.” 

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For industry-sponsored trials, the sponsor will not release the protocol and/or study related information to the PI until a confidential disclosure agreement (CDA) is executed between the sponsor and USC. Sometimes a CDA is referred to as a non-disclosure agreement (NDA), though the function is the same. 

The CDA/NDA may be a one-way (unilateral) agreement that requires only the receiving party to maintain secrecy. For example, a sponsor may provide information to a PI so he/she can determine if he or she would like to participate in a study. The CDA/NDA or clause may also be a two-way or mutual agreement in which both parties exchange confidential information and are obligated to maintain secrecy. Regardless of whether the agreement is unilateral or mutual, information provided to USC under the agreement cannot be disclosed to a third party or may be limited to persons within USC on a need-to-know basis.

Access to confidential information must be limited to personnel who need the information to perform the study, work with patients or work with ancillary groups. The information should never be shared outside of USC and should only be shared with others at USC if they need to know the information, and if they are informed that the information is confidential. PIs and CRCs alike are responsible for protecting confidential information. Consult USC’s “Guide to Confidentiality” for further information. 

The sponsor will provide a draft CDA to the CRC, which he/she will submit through OnCore. Once submitted, a contract manager at the USC CTO will work directly with the sponsor to execute the agreement. Once the terms have been agreed upon, the PI will need to sign, as well as an authorized signatory authority for USC, and a representative from the sponsor. Once fully executed, the sponsor will send the protocol and related documents for review and the CRC will complete the feasibility questionnaire.

Finally, it is important to note that confidentiality requirements may also appear in a clause within a CTA, technology license, data sharing agreement, or material transfer agreement (MTA).

Industry-sponsored trials require a site qualification visit, also known as a pre-site selection visit, in which the sponsor or a Clinical Research Organization (CRO) visits USC to determine if the site is suitable for the study. During this visit, the equipment, facilities, pharmacy, staff, and patient population will be evaluated to determine whether or not the site can successfully conduct the trial and meet patient accrual goals set by the sponsor.

Contract and Budgeting Process Guidance Map

This guidance map below provides information about which office handles which aspects of the budgeting and contracting process based on two things: the study’s funding source and whether or not the study will use hospital resources such as clinic rooms, pathology, etc.

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1. Contracting Process 

For industry sponsored studies, the CTO supports PIs and research sponsors in the creation of CTAs that support development and testing of novel therapies, devices and diagnostics. 

The CTO’s operations have three main components: 1) contract review, negotiation, and execution; 2) coverage analysis; 3) budget development and negotiation. 

CTO uses OnCore, a clinical trials management system that allows study teams to maintain the protocol submission, study calendar, budget summary, participant tracking and invoicing, etc. CTO’s post-award team performs functions previously done by Sponsored Projects Accounting (SPA), as SPA is no longer involved in industry-sponsored studies. As of April 2016, all new clinical trials will be initiated in OnCore. Click here to see the memo from CTO regarding the OnCore Implementation plan. 

The CTO is divided into teams, each responsible for a number of departments. Each team includes a senior contract manager, budget specialist, and coverage analyst. Post-award accountants are assigned to various departments as well. 

CTO: To arrange for training or assistance with OnCore, complete the OnCore Training Request Form.
Email: OnCoreSupport@med.usc.edu or call 323-442-7218.
For a list of contacts at the CTO, click here.

The following bullet points outline the various types of agreements and illustrate the process for CTO’s most frequent activities, identifying the specific responsibilities of the study team versus the CTO staff:

Confidentiality Agreement

● The PI should initiate a CDA submission by submitting through OnCore
● After negotiation of CDA language, the PI should sign to indicate that he/she reads and understands the language (prior to signature by the CTO’s contract negotiator)
● Once CDA is executed, the PI and study team should ensure that information is kept confidential and only provided to people at USC on a “need to know” basis. Those who need to receive information should be given access to the minimum amount of confidential information necessary to effectuate the study, informed of its confidentiality, and informed that confidential information should never be shared outside of USC

Clinical Trial Agreement (Sponsored-initiated)

● The PI should initiate a clinical trial submission through OnCore
● In the submission, the PI should include the study protocol authored by sponsor, sponsor’s proposed Clinical Trial Agreement (CTA), lab manual(s) and sponsor’s proposed budget and informed consent in this submission. Additional essential documents include the protocol, Investigator Brochure, NCT # (for ClinicalTrials.gov), and CTU order form (as applicable)
● The PI and study team should respond to queries from budget specialist regarding budget parameters as first response to sponsor’s initial budget
● Once the CTO completes negotiation, the PI should approve the budget, including the final signature and approval by Department Chair or designee of Department Chair

Clinical Trial Agreement (For PI-initiated, industry-funded study)

● The PI should initiate a clinical trial submission through OnCore
● The PI should include the study protocol authored by the PI, sponsor’s proposed CTA, if available, and PI’s proposed budget
● The PI should respond to queries from budget specialist regarding budget parameters as required to cover the study costs
● Once the CTO completes negotiation, the PI should approve the budget, including the final signature and approval by Department Chair or designee of Department Chair

Medicare Coverage Analysis Process

● Coverage analysis occurs by the CTO automatically as soon as the OnCore submission is completed
● The PI should review and approve coverage analysis determination showing services and activities that will be paid by sponsor, insurer or other USC account 
● Once study is activated by CTO’s budget specialist in OnCore, the PI and study team agrees to conduct clinical trial in accordance with the CTA and approved protocol. At this time, the PI and study team should seek IRB approval 

Contract Review, Negotiation, and Execution

The CTA is the contract between the university and a sponsor. It outlines the obligations for each entity and defines the scope of work on a clinical trial. For example, a CTA will state contract terms associated with:

● The amount that USC will be reimbursed for work on a trial, and the conditions by which USC will be paid (e.g., startup costs and per-patient enrollment costs)
● Obligations to protect confidential information
● Rights of the sponsor to monitor the work at USC, and to inspect patient records
Liability in case something goes wrong in a trial
● Rights to intellectual property created prior to and during the trial
● Rights of the university to publish research that relies on data collected during the trial
● Study-related PI and USC obligations, including reporting of Adverse Events and other reports prepared pursuant to the study protocol
● Study period and procedures associated with early termination of the study

The CTO negotiates with the sponsor to ensure that the contract terms are reasonable and fair, while aiming to start trials and enroll patients as quickly as possible. The CTO senior contract manager is responsible for negotiating the non-financial terms of the CTA. The starting point for this work is typically a template agreement provided by USC—or more commonly, by the sponsor. In some cases, USC has negotiated a master agreement with a sponsor that pre-determines many of the terms and conditions, thus expediting negotiations. 

When a template comes from the sponsor, the proposed CTA includes the industry sponsors’ preferred contract terms. The CTO senior contract manager is responsible for reviewing these CTAs in order to identify terms and conditions that are inconsistent with governing federal regulatory policies and regulations (e.g. FDA, HIPAA privacy rules) and USC policies and regulations with respect to participants, such as dissemination of research results and management of potential intellectual properties developed during the performance of the study, in accordance with sponsor’s protocol. 

The CTO senior contract manager will focus on finding language that is acceptable to both USC and the industry sponsor. During this process, the CTO senior contract manager may consult with and receive input from the PI, USC Office of the General Counsel, USC Stevens Center for Innovation, and USC Department of Risk Management and Insurance, as needed. Upon finding mutually acceptable alternatives for all disputed terms (except the budget and payment schedule), the CTO senior contract manager will facilitate the development of a clean copy of the negotiated CTA that is ready for signatures, pending the completion of negotiations conducted by the budget specialist (i.e. the CTA budget and payment terms). 
The CTO’s practice is to negotiate budget and payment terms in parallel with other types of contract terms. In some cases, depending on the items in dispute, this means that the budget and payment negotiations may have been completed before or after the completion of the CTO senior contract manager’s work. In such instances, the clean copy of the negotiated CTA will be ready for signatures. 

Medicare Coverage Analysis (MCA)

On a clinical trial, some costs for patient care may be billed to an insurer, and some costs may be billed to the sponsor. However, it is inappropriate and unlawful to bill a particular cost (e.g., a lab test or procedure) to both the insurer and the sponsor, and certain costs may only be billed to the sponsor.
In 2000, the Centers for Medicare and Medicaid Services (CMS) issued a national coverage determination (NCD) for clinical trials that defined which costs are billable to Medicare. Under the NCD, Medicare will only pay for routine patient care costs, certain research costs, and costs due to complications associated with participation in qualifying clinical trials. USC follows these same standards for all insurers. It is essential for USC to do so because violations might subject the university to fines under the False Claims Act.
To meet its obligations under the NCD, CTO conducts an assessment called a Medicare Coverage Analysis (MCA) to determine which activities to be undertaken in connection with a clinical trial may appropriately billed to insurance and which must be billed to a research sponsor. Generally, the process for making this assessment is as follows:
● Initiate a clinical trial submission through OnCore
● Include the study protocol authored by the PI, sponsor’s proposed CTA, and Sponsor or PI’s proposed budget. All essential documents related to the clinical trial below need to be included:

  • The protocol
  • Investigational drug/device brochure
  • Draft CTA
  • Sponsor’s proposed draft budget
  • Laboratory manual
  • Investigational New Drug (IND)/Investigational Device Exemption (IDE) letter
  • VAC form for device studies
  • Names of research personnel involved in the study and hourly/administrative rates
  • Sponsor contact information
  • NCT number

● CTO reviews the protocol and sponsor’s budget and other related documents and assesses which costs associated with the trial are “routine patient care costs,” and which are not.
● The completed coverage analysis is used to develop a counter-proposal to the sponsor’s proposed draft budget. CTO then negotiates with the sponsor and finalizes the research agreement and associated budget.
● Once the budget is finalized, a Research Order Form (ROF) is generated that is used for ordering all tests and procedures identified in the study protocol. The ROF indicates which services should be billed to insurance or Medicare as applicable and which should be billed to a USC research account. If a service is not billable to insurance, it must be charged to a research account identified on the ROF. 

Coverage Analysis Process
While the senior contract manager is starting to review the CTA, the coverage analyst will simultaneously begin working on developing a study-specific Coverage Analysis that identifies and distinguishes any and all costs that must be charged to the sponsor (research-related) from those routine patient care costs that could be charged to private insurance or Medicare, as applicable. Coverage analysis is completed for all clinical research, whether it is sponsored by industry or not. 

Budgeting Process 
To start, the CTO budget specialist starts to build USC’s first response to the sponsor’s proposed budget after the coverage analysis is completed. The CTO budget specialist works with PIs, CRCs, department financial administrators, and representatives from other participating units to produce a comprehensive budget that will facilitate the process of negotiating the budget and payment terms with the sponsor. In addition to completed coverage analyses, the CTO budget specialist uses the study protocol, sponsor’s budget spreadsheet, informed consent, and contract payment terms to complete the development of USC’s first budget. USC’s first budget is then sent to the sponsor for their review and response. This is where the budget negotiations will begin, focusing on differences between USC and the sponsor’s budgets. 

Upon reaching an agreement with respect to the budget and the payment schedule, the CTO contract officer is charged with finalizing the entire clinical trial contracting process (assuming that the contract term negotiations are completed as well). This process includes collection of all the necessary documents (including a fully executed CTA with the final budget and payment schedule) and performance of all the required data entries and verifications in Database Management Systems such as iStar and OnCore. The CTO contract specialist will conduct a consistency check in which the specialist checks the language in the ICF against the terms of the contract to ensure consistency. Once the consistency check is complete, the stamped versions of the ICF will be released and iStar will send a letter to the study team notifying them that the study can begin. Once the signed CTA and other relevant documents are uploaded in OnCore and study is activated in OnCore, the post-award management of the clinical trial will start through activities such as creation of a financial account, initiation of invoicing/billing, and the conduct of necessary monitoring procedures.

Negotiation Delays and Hold Status
If the negotiations are delayed, the CTO may submit a “hold request” to the CTO Director. The CTO staff will then attempt to follow up to obtain the necessary information to complete any part of the process outlined in this sub-section. Study staff will be notified if the study is put on hold. If the hold is due to study team delays, it is their responsibility to provide the necessary information and submit an email request to the CTO project specialist or contract manager to remove the hold and resume negotiations. The CTO and the study staff monitor holds that are due to the sponsor’s delays, whereas just the study team monitors holds that are due to pending IRB approval. Once the information has been updated, the study that was previously on hold is reassigned and the study is treated as a new submission, so the timelines will reset.

The process is complete when the CTO has uploaded the final, executed documents onto OnCore (including the MCA, contract, budget, and ROF), and the award is forwarded to the Keck School of Medicine. After the appropriate documents are processed, the study can proceed to the next step, which involves IRB approvals.

USC CTO: 323-442-7218
Sara Katrdzhyan, Pre-Award Manager: Sara.Katrdzhyan@med.usc.edu  


1. USC Clinical Trials Unit (CTU)
The USC Clinical Trials Unit (CTU) provides the infrastructure, resources, and support to conduct human studies, with a focus on early phase and complex mechanistic trials. CTU can assist study teams with accommodating patient visits for high intensity trials that involve serial blood draws, infusions, and monitoring. The CTU also has trained clinical staff like research nurses, phlebotomists, radiology technicians, and more. The staff is highly experienced in collecting and processing PK and PD samples in a timely and efficient manner.

CTU: Yolanda Gutierrez, Assistant Director for Clinical Research Operations; 323-865-3056; cerda@med.usc.edu or ctu@sc-ctsi.org

The CTU also offers a specimen-processing center that offers a variety of services and serves as a one-stop unit for processing, storing, and shipping research samples collected from research patients. The USC CTU has the capability to provide X-ray absorptiometry (DEXA) for body composition or bone densitometry studies. The CTU also provides specimen collection and processing services that may include blood, saliva, sputum, urine, stool, hair follicles and other types of specimens. In addition, the CTU Processing Center can perform specialized processing for studies in which the assays are run in the investigator’s lab, research core lab, or sponsor’s central lab. Specimen processing may include the following: Serum/plasma separation, buffy coat separation, custom labeling, centrifuging, aliquoting, blood smear, PBMC separation; assistance with shipping & handling (ambient, refrigerated, dry ice). To learn about CTU’s full capabilities, click here.

CTU Laboratory: Lilit Baronikian, CTU Lab Supervisor, 323-865-3379 (office) or 818-642-4838 (cell), yegiyant@med.usc.edu

2. USC Investigational Drug Services (IDS) Pharmacy
IDS Pharmacy supports human studies involving investigational products and supports safety and care for research participants in both the inpatient and outpatient areas. IDS Pharmacy integrates its activities with the clinical, safety, informatics, administrative, and drug distribution systems of the hospitals and clinics to optimize investigational product therapy for patients. IDS Pharmacy assists with regulatory compliance, integrity of blinding and randomization, dispensing of investigational products, temperature monitoring, and more. 

Coordinating with the IDS Pharmacy early on is crucial to ensuring that they can accommodate requests for creating, storing, and dispensing the study drug, even during the site qualification phase. If the study requires the use of an investigational product, the PI will need to involve the IDS Pharmacy.

You should contact the IDS Pharmacy via e-mail as soon as you have identified that your study involves investigational product (ideally before IRB submission). They will respond within 1-2 business days and they will draft a scope of service agreement that details your study’s pharmacy fees depending on whether it is industry-sponsored, government-sponsored or investigator initiated.
  
It may be necessary to set up a site qualification visit. If so, the study team should inform them of the items to be assessed during the site qualification visit and work with them to prepare accordingly. The study team should provide additional information to the IDS Pharmacy that will help them determine how feasible it will be for them to take on the study. For example, providing information about the estimated number and size of the study kits or investigational drug that needs to be stored, how frequently they will be shipped, and how the drug will need to be dispensed and stored will be helpful to the IDS team. 

If on-campus pharmacies are unable to accommodate, it will become necessary to explore other options such as third-party pharmacies near HSC campus to see if they can assist with storing and dispensing the drug. There are local third-party compounding pharmacies that can assist with dispensing drugs, and other compounding pharmacies around the U.S. that can assist with creating drugs and placebos. Their fees will depend on the details of the study. 

IDS: PIs should contact the IDS Pharmacist (idspharmacy@med.usc.edu, 323-865-3538) to determine study feasibility and budget requirements. Depending on the protocol, pharmacy services may be conducted at the IDS Pharmacy or transferred to satellite sites (such as Keck Hospital of USC or Norris Cancer Hospital).

Other Pharmacies: For a list of possible pharmacy options beyond those at HSC, contact the SC CTSI CRS group at crs@sc-ctsi.org

3. Radiology & Imaging
Radiology and imaging services are available at the Norris Cancer Center and at Keck Hospital (Healthcare Consultation Center II and the PET Center in Healthcare Consultation Center I). Patients recruited from LAC+USC may be imaged at HCC2 or the PET center only if funding is available. The process can be initiated while the study is under review by the IRB. However, no research scans may be scheduled until the study has final IRB approval, which is contingent on RSC approval. In addition, research scans can’t be scheduled until ROF is available and Radiology Scan Request form (if applicable) is completed. Radiology research imaging charges are determined by the coverage analysis performed by the CTO. Please note there is a charge of $330 by the Department of Radiology for completion of RECIST tumor flow sheet form by a radiologist. Please make sure CTO is aware and prepares your budget accordingly.

Radiology: The coordinator will send an email to Bhushan Desai (bhushand@usc.edu; 323-865-9949) or contact the Department of Radiology at 323-442-8541, outlining the imaging requirements for the study and provide any additional materials (i.e., imaging manual). Imaging can be requested using the Research Order From created by the Clinical Trials Office. 

Imaging
Center for Image Acquisition
The Center for Imaging Acquisition, part of the USC Mark and Mary Stevens Neuroimaging and Informatics Institute, houses MRI equipment used for neuroimaging. The Center has other equipment to help PIs conduct scans that ensure the comfort for participants. Click here for a full list of equipment and capabilities. 
CRCs can schedule appointments with the Center by creating an account under the “For Investigators” tab. The following information will be needed for the application: project name, proposal number, PI name, anticipated start date, copy of IRB approval letter, copy of study budget showing scan costs. Once the application is approved, login credentials will be provided, and users will be able to schedule online. Investigators preparing budgets for new proposals should contact the center to obtain the latest rates for scans and other services. Please allow at least 2 weeks for rate requests to be approved. 

CIA: Direct any questions to CIA@ini.usc.edu.

Molecular Imaging Center – Radiochemistry/Cyclotron Labs
The Molecular Imaging Center (MIC) is a comprehensive imaging program focused on the development of various types of PET tracers used for imaging disease. The facility includes a Cyclotron GMP facility, PET radiochemistry laboratories, access to small animal imaging, and access to clinical PET/CT imaging facilities. 

PIs interested in utilizing these services should contact Peter S. Conti, MD, PhD to set up an initial meeting to discuss the feasibility of the study, the radiotracer availability/preparation and clinical trial enrollment. Clinical imaging studies will be performed under pre-IND, IND, or approved drug protocols at HCC-I. Opportunities for early-phase clinical trials and multi-center trials are available at MIC including existing trials in the following areas:

Oncology:
● Breast Cancer
● Prostate Cancer

Neurodegenerative Disease:
● Alzheimer’s Disease
● Parkinson’s Disease

Cardiovascular Disease:
● Cardiac Ischemia

4. Pathology
The point of entry for all human biospecimen procurement needs is the Translational Pathology Core Facility (TPCF) of the USC/Norris Comprehensive Cancer Center, including whether for clinical trials, non‐interventional translational research studies, basic research studies, and whether cancer‐related or not. In this capacity, the TPCF works closely with the hospital‐based employees of the LAC+USC Medical Center and the Keck Medical Center to facilitate the process of research tissue acquisition and processing and to insure compliance with federal, state, and local hospital regulations. The activities of the TPCF are supported by chargebacks to the study PI. Any investigator may request services from the TPCF, and Cancer Center members receive services at a discounted rate. Specimens can be obtained by USC investigators with IRB approved, funded studies with a valid Lab Agreement.

For all research studies requiring the use of human biospecimens, including both clinical trials and non‐interventional (non‐clinical trial) translational research and basic research studies, investigators must submit the Laboratory Agreement Request Form in order to obtain approval to procure biospecimens. The laboratory Agreement Request Form must only be submitted after funding and IRB approval have been obtained. Once the Lab Agreement is approved, the investigator will meet with Pathology to arrange the implementation of the biospecimen procurement, processing, and distribution required by the protocol. 

For clinical trials, once the trial is opened, two additional forms will enable investigators to request procurement from individual patients: Request for Formalin Fixed Paraffin Embedded (FFPE) Slides/Tissue Blocks and/or Request for Fresh/Frozen Tissues can be obtained from and submitted to Ms. Chen. 

Types of human biospecimens available for research: 
1) Formalin-fixed, paraffin-embedded (FFPE) tissues: 
All tissues taken during the course of clinical care are saved for a period of time in the hospital archives in the form of FFPE blocks. These can be used for research purposes provided appropriate consent and IRB approval have been obtained. At Keck Medical Center, these tissues are stored indefinitely. At LAC+USC, the FFPE tissues are stored in the hospital archives for 10 years, at which point they are donated to the Population Based Tissue Arm of the TPCF (Wendy Cozen, DO, director). TPCF personnel can assist with procurement and sampling (e.g., sectioning, coring) of FFPE blocks in the hospital archives. 
2) Fresh, fresh/frozen, and fluid specimens (e.g., whole blood, serum, plasma, buffy coat, and urine):
Fresh, fresh/frozen and fluid biospecimens can be collected prospectively for IRB approved, funded studies with a valid Lab Agreement and patient Informed Consent. Typically both tumor and matched normal tissue are collected immediately after explanation under the supervision of the service pathologist/PA. The TPCF personnel will assist with the immediate processing and storage of the specimens, banking, tracking, distribution, and processing of specimens required for analysis.
 

5. IRB Application Submission and Approvals Process 
In order to initiate the IRB application submission process, the study application and protocol will need to be submitted to iStar. All co-PIs must agree to participate in the study before the PI can submit the application to the IRB for review. Ultimately, the application needs to be approved by the PI or co-PI in order to finalize submission, after which the Division/Departmental must approve the application in order to route the study for IRB. IRB staff are then assigned to conduct a cursory review. 

All investigator-initiated non-cancer clinical trials that have not undergone prior scientific review by a qualified scientific body are automatically routed to the SC CTSI Clinical Research Support Scientific Protocol Review Committee to undergo scientific and feasibility review as a part of the IRB review process. More information regarding the Scientific Review process can be found in Section V. IRB Approvals Process, subsection E.

After scientific review is complete or not deemed necessary, the IRB administrator categorizes the study as Full Board, Expedited, or Exempt. If the study is subject to Full Board Review, as is true for most clinical trials, the study will be assigned to a Committee Review. During the Committee Review Process, the board members will conduct independent reviews, followed by a Committee Meeting during which the study protocol and corresponding risks are discussed.

Process.png#asset:6739

If the IRB has questions or issues with the protocol, contingencies will be given to the PI and study team. A contingency is an item from the IRB that must be addressed in the next submission before the IRB can approve the study. When responding to the IRB, it is best to err on the side of caution and explain the decision making and study processes in more detail rather than less so that the analyst and/or board can understand the rationale without having to ask for clarifications from the PI and study staff. Once all contingencies have been adequately addressed, the IRB will approve the protocol within iStar. The approval comes in the form of an IRB approval letter uploaded to iStar that outlines what was approved. However, it is important to note that IRB approval does not necessarily mean that the study can begin, especially in the case of industry-sponsored trials. Once the contract is finalized, the IRB will re-issue an approval, indicating that the study can begin. At this time, the IRB will also release the approved and stamped ICFs.

Upon release, the IRB approval letter and ICF is approved for one year for one year from the release date. If the study plans to continue past one year, continuing review must be completed. More information about continuing review is found in the Appendix. If the study closes after one year, more information about that process is also found in the Appendix. More information on the USC IRB and the Office for the Protection of Research Subjects (OPRS) can be found here.

6. Site Initiation Visit for Industry-Sponsored Studies
Once the PI has executed the CDA on OnCore, received the study synopsis, and USC has been selected as a site, the sponsor will send over the regulatory packet and contract, as well as the budget templates. The PI and staff will upload the essential documents and templates into OnCore, submit to the IRB (see Section V for more information), and start building the initial budget in discussion with the sponsor. 

Once the contract is fully executed or likely to be full executed, the PI and staff will schedule the Site Initiation Visit (SIV). (The industry study representative, usually the CRA or Monitor, will need to register via Intellicentrics and ensure to follow all USC visitor protocols while on site.) The purpose of an SIV is to have the PI, site study staff and sponsor meet to discuss the study, have the sponsor train the study staff on the protocol, and discuss the roles of the PI and team members and the delegation of study-related tasks. Toward the end of the SIV, the involves parties will complete the Delegation Log, and the sponsor staff will ask if there are any questions before the SIV training log is completed. The CRC should keep a copy of the training log for study records.

Additionally, if a device will be used as part of the study, the PI and staff will submit a Value Analysis Committee (VAC) form to the hospital. The VAC form is necessary if the PI is planning to use the device in any of the Keck hospitals or affiliated clinics. Whether or not the PI or department plans to purchase the device or receive it at no charge, they will need to complete a Purchasing Order Form, which will be processed through the CTO. More information about the VAC process is included in the section titled, “Approvals Process for Using Devices within Keck Hospital.” 


Section IV. Study Lifecycle: Planning/Pre-Submission

As part of the study start up process, PIs and research staff will need to gain access to relevant USC systems that will allow them to carry out necessary tasks involved in clinical research conduct. These systems include OnCore, Kuali Coeus (KC), iStar, REDCap, and more. Some systems can/will be used for all clinical research studies regardless of their funding source, such as iStar and OnCore, whereas some will be used only if a study is funded by a specific source. 

Users must have a USC email address before accessing these systems, and some require Shibboleth or Duo authentication to access. The links below provide information about each system. For setting up access to these systems, contact the appropriate help desk:

OnCore: OnCoreSupport@med.usc.edu or call 323-442-7218
Kuali Coeus: Departmental finance managers should be able to assist PIs and study personnel with access and troubleshooting KC
iStar: istar@usc.edu or call 323-276-2238
REDCap: For information on how to obtain a REDCap account, click here. support@sc-ctsi.org or call 323-442-0217
Sophia: Click here to access Sophia
DiSClose: Click here to access diSClose
CITI: citi@usc.edu or call 213-821-5272
ClinicalTrials.gov: Click here for info on how to register a study
USC eMarket: Click here for access information

Setting up a USC Email Account
Access to relevant online systems at USC (including iStar, OnCore, and others) requires set up of a USC net ID account and obtaining a USC email address ending in @med.usc.edu or @usc.edu, depending on the home department. During the onboarding process, department HR managers will assist with the set up of these accounts. 

For issues with USC email, contact the Keck IT Helpdesk at 323-442-4444 or helpdesk@med.usc.edu. For issues with the net ID, contact the USC Helpdesk by phone 24 hours a day, 7 days a week at 213-740-5555 or consult@usc.edu.

During the planning stages of an investigator-initiated study, prior to submitting a protocol to the IRB, a PI starts out with an idea for a research study. She will consider who will fund the study; how the study should be designed, statistically analyzed, and operationalized; what type of equipment is needed; how many participants she is looking to recruit over what length of time; and more. She will think about her study team and perhaps recruit personnel to join her staff, as well as any necessary trainings they should complete. 

When an idea is in this phase, a PI should begin by obtaining a biostatistics consultation. Biostatisticians can assist with protocol design, statistical planning, feasibility analysis, and more. USC investigators have two options for biostatistics help, depending on the nature of the support needed and the PI’s affiliation. The Norris Cancer Center Biostatistics Core focuses on cancer studies for members of the Norris Comprehensive Cancer Center. 
SC CTSI BERD typically focuses on short-term statistical collaborations across the lifespan of a study. However, they also offer a longer-term solution to the need for statistical assistance in the form of a biostatistician whose time can be contracted on an effort-based basis. 
Details about each option available at Norris and SC CTSI, as well as other opportunities for statistical consultation, are provided below.  
a. Norris: Contact the Norris Cancer Center’s Clinical Investigations Support Office (CISO) at 323-865-0463 or CoreCISO@med.usc.edu to schedule a feasibility meeting for the proposed clinical trial or study with representatives from all the relevant cores. There is no charge to Cancer Center members for Biostatistics Core support.  However, Cancer Center members are fully expected to include statistical faculty and staff on grant application budgets and on contracts.  
b. SC CTSI BERD: Fee-for-service rates: $125/hour after initial free consultation up to one hour. For some investigators, CTSI provides a subsidy of extra support, indicated below. The only way BERD will process requests for assistance is through completion of their online service request form.

If the PI is…

He/she is eligible for additional free support per year in this amount:

Junior investigator

Up to 5 hours/project

(3 projects max per year, so 15 hours annually)

SC CTSI Pilot Funding Awardee

Up to 2 hours per project

K Scholar

Up to 15 hours annually, only while they are in their K-funded period

T Trainee

Up to 15 hours annually, only while they are in their T-funded period

Working on extramural grant planning

Up to 3 hours per grant

PM516 Volunteer

Up to 5 hours

Clinical research informatics and bioinformatics resources can assist PIs with the research process by streamlining the study planning process, helping with feasibility assessments using local patient counts, and more. 

SC CTSI Clinical Research Informatics (CRI) core provides various tools to assist with cohort discovery, to explore available patient populations across Keck, DHS, and other hospitals in Los Angeles. One such tool includes i2b2, a tool that allows study teams to plan human studies by searching Keck, DHS, and CHLA patient records. Study teams can obtain de-identified, aggregate, and identified patient databases with IRB approval. 

Another tool is TriNetX, which includes data from i2b2 but contains many more features which allow users to visualize data in more appealing ways. Users wanting to use i2b2 or TriNetX will need to request an account from CRI.

Please note that in order to release identified patient data, the PI and study team must obtain IRB approval for each specific piece of data they would like to request. For example, if the team is requesting patient name, address, phone number and email address, they must explicitly request this in their IRB amendment and it must be approved by USC IRB before the Informatics team can pull and release the identifiable, patient-level data to the PI and team. 

Norris Bioinformatics core offers a range of services to researchers across the Cancer Center at USC and other academic institutions on a fee-based or combination of fee- and collaboration-based service. Services include in-silico (computational) bioinformatics-based analysis to basic, clinical, and translational research applications.

Another tool, called the Los Angeles Data Resource (LADR) Cohort Discovery System, is a joint project between USC, CHLA, UCLA, City of Hope, and Cedars-Sinai. LADR allows PIs to search for the number of patients meeting their proposed inclusion/exclusion criteria across these five hospitals.
 
The Cancer Research Informatics Core (CRIC) develops and supports databases for laboratory data management, multi-center clinical trials coordination, epidemiologic & prevention studies as well as disease specific studies. Equipment and services include tools for data collection, migration and reporting, customized survey creation, and web-based data capture & reporting.

Norris Library provides bioinformatics support including statistical analysis of high-throughput data and DNA/protein sequence analysis, comprehensive functional analysis and advanced literature and data search and mining, as well as workshops and training of available software tools.

CRI: To obtain an account or get training, email the support team at i2b2@usc.edu or call 323-442-0217.

Before undertaking any study, the PI and study team must determine the feasibility of conducting the study at their institution. This involves (but is not limited to) assessment of the following factors:

● proposed study budget and availability of local resources
● ability to recruit the necessary number of participants who meet the inclusion criteria
● the research team’s effort or time
● availability of the PI to oversee study conduct
● sufficient funding to run the study and compensate participants
● pool of eligible participants
PIs can use cohort identification tools such as i2b2 to assess feasibility at USC. The “Clinical Research Informatics Resources” section contains more information about cohort identification tools.

When assessing the availability of resources required to successfully carry out an IIT or sponsored trial, a PI may realize he doesn’t have adequate space to carry out the study.

1. The USC Clinical Trials Unit (CTU) specializes in medium to high-complexity human studies that involve serial blood draws (i.e. PK & PD). The CTU provides for-fee space (located in the Breast Center in HC4) for conducting study visits, as well as qualified research personnel such as research nurses, phlebotomists, and lab technicians. 

CTU: Yolanda Gutierrez, Assistant Director for Clinical Research Operations, cerda@med.usc.edu, 323-865-3056 or ctu@sc-ctsi.org

2. The Diabetes & Obesity Research Unit (DORI) located in the Clinical Sciences Center also provides space and services to conduct research, such as nursing and phlebotomy services, patient rooms, and metabolic tests such as DEXA scans.

DORI: Christina Ayala, MPH, Project Manager, trujillc@usc.edu, 323-442-2500. 

In order to work with human participants and protected health information, all research personnel must be appropriately trained and certified. These certifications should be kept up-to-date before they expire in order to ensure compliance. 

The USC Office of Research hosts several online trainings on a variety of topics. These trainings can be accessed through the Research Training Finder. Users can filter trainings based on role (administrative staff, faculty/PI, research coordinator, and more) as well as their responsibilities (managing contracts and grants, shipping biological materials, handling human tissue, etc). In addition, USC offers training through the CITI program as well as access to modules provided by the Association of Clinical Research Professionals (ACRP). Your department administrator should have the login and password to access these ACRP trainings. For any questions about ACRP training and login access, contact Clinical Research Support at crs@sc-ctsi.org

For research administrators and support staff who work in contract and grant development, a relevant training includes a 12-course online module called “the Cardinal and Gold Curriculum.” A Grants Management Training Program for PIs also can be accessed from the Office of Research website.

The USC Environmental Health & Safety (EHS) department hosts multiple in-person trainings for research staff working with a variety of devices and substances. For example, if you have the potential to be exposed to bloodborne pathogens, you’ll need to attend the bloodborne pathogens training. If you’ll be responsible for shipping and handling biological materials, you’ll need to attend the training on shipment of biological materials and/or dry ice. These trainings are held multiple times per month virtually via Zoom. Registration is required and can be completed online at this website. To better understand what trainings you should obtain based on your responsibilities, use this guide sheet. If you have any questions, email EHS at ehs@usc.edu or call them at 323-442-2200.

Finally, the Regulatory Knowledge and Support (RKS) group at SC CTSI has a training module for how to ensure clinical trial quality and how to monitor a study that can be accessed here. They also have other educational offerings, training resources and videos from their previous boot camps/symposia here.

For an overview of required trainings for new or junior investigators, see the figure below, also found at the beginning of this section of the Guide To Clinical Research.

Investigators-quick-guide.jpg#asset:6727Investigators-quick-guide-2.jpg#asset:6728

During the training phase, a PI may also realize he does not have adequate staff effort to dedicate to the conduct of the project or trial. Some departments have their own pool of dedicated study staff, such as research coordinators, research nurses and project assistants. If you are unsure whether your department has such resources available, consult with your department administrator. 

If your department does not have dedicated study staff, there are options to hire staff through the SC CTSI Clinical Research Support group, and the Clinical Trials Unit.

Study coordinators are available for hire through the SC CTSI’s clinical research coordinator pool. These CRCs are highly trained, familiar with the process of conducting research at USC, Keck, and LAC+USC, and can be available for short or long-term project needs. They can assist on any type of clinical research including IITs, non-industry funded, and/or industry-funded studies. Most CRCs are bilingual and fluent in Spanish, and many are phlebotomy-certified. These skills can be requested by the PI if needed and are based on availability. If you are interested in obtaining more information about hiring a CRC, contact the Clinical Research Support Research Coordinator Supervisor Lily Jara or 626-483-7876.

Research nurses are available for studies utilizing the USC Clinical Trials Unit (CTU). CTU provides the infrastructure, resources, and support to conduct human studies – such as space for physical examinations, infusions, biopsy procedures, laboratory and processing of bio-specimens, nursing and phlebotomy services, and more. To obtain more information about the CTU, including cost, contact the Assistant Director for Clinical Operations Yolanda Gutierrez or 323-865-3056.

Finally, ensuring your staff members are properly trained and delegated to perform the tasks associated with the study is a necessary part of the planning process. Researchers who propose or conduct research sponsored by the Department of Health and Human Services (i.e. NIH, CDC, AHRQ, HRSA) must complete conflict of interest in research training every four years. For more information about necessary human subject-related trainings, see the Investigators’ Quick Guide to Getting Started in Clinical Research at USC on page 14-15.

Any PI or research staff conducting research within a Keck Medical Center of USC facility – including hospitals and ambulatory locations – must be credentialed to access and work in that facility.

Contacts by location
Keck Medical Center of USC:
CRCs and any non-physician research associates must be credentialed in order to perform study-related activities at Keck and any of its affiliates including Norris, Verdugo, and associated clinics. The credentialing paperwork involves the completion of forms and submission of documents including picture ID, license/certificates, professional liability insurance, CV, health clearance documents, questionnaire and more. Be advised that this approvals process can take between 2-3 months. 

Any questions about necessary credentials and clinician privileges should be directed to Ellen Whalen, Associate Administrator Academic Affairs; Ellen.Whalen@med.usc.edu. The phone number for the Office of Integrated Credentialing is 323-442-6820.

To gain access to hospital facilities including freezer spaces and operating rooms, research personnel must contact the HR manager for their department as well as HSC Facilities: Ana Orvieto; Ana.Ortega@med.usc.edu

LAC+USC Medical Center: Employees of USC/Keck who also need access to LAC+USC Medical Center facilities will be onboarded as contracted employees through a departmental sponsor at LAC. The HR manager for your department should be able to refer you to the appropriate sponsor contact at LAC. The onboarding process involves completing a health clearance and background check before a badge can be obtained. The health clearance process involves providing copies of your immunization forms, and proof of a negative TB test taken within the last six months. Copies of these documents should be brought to the Employee Health desk located at the first-floor office in the IRD building at LAC+USC or emailed to the contact designated by your department’s HR manager.

LAC+USC HR: 323-409-2300; lacuschr@dhs.lacounty.gov

Coordinating ancillary services early on is crucial to ensuring there are minimal delays in the study preparation process. Relevant ancillary services include radiology & imaging, pharmacy, pathology, cardiology, and ophthalmology. There are over 60 research laboratories and services located at UPC, HSC, and CHLA, offering researchers access to state-of-the-art facilities, technologies, resources and expertise across academic disciplines and clinical specialties. Researchers can use the link above to segment searches for labs and services based on location or research area.

The following section provides a description of the services provided, how to request the service, and contact info. 

1. USC Medical Plaza Pharmacy
There is another pharmacy, in addition to IDS pharmacy, located on the HSC campus. The Plaza Pharmacy is located in HC2 and can assist with filling prescriptions and dispensing drugs for studies on a limited basis. PIs should discuss needs early on to see if Plaza can accommodate the study drug.

Plaza Pharmacy: Contact Rena Charchian; Director of the Plaza Pharmacy; 323-442-5770

2. Radiology
Radiology and imaging services are available at the Norris Cancer Center and at Keck Hospital (Healthcare Consultation Center II and the PET Center in Healthcare Consultation Center I). Patients recruited from LAC+USC may be imaged at HCC2 or the PET center only if funding is available. The process can be initiated while the study is under review by the IRB. However, no research scans may be scheduled until the study has final IRB approval, which is contingent on RSC approval. In addition, research scans can’t be scheduled until ROF is available and Radiology Scan Request form (if applicable) is completed. Radiology research imaging charges are determined by the coverage analysis performed by the CTO. Please note there is a charge by the Department of Radiology for completion of RECIST tumor flow sheet form by a radiologist. Please make sure CTO is aware and prepares your budget accordingly.

Radiology: The coordinator will send an email to Bhushan Desai (bhushand@usc.edu; 323-865-9949) or contact the Department of Radiology at 323-442-8541, outlining the imaging requirements for the study and provide any additional materials (i.e., imaging manual). Imaging can be requested using the Research Order From created by the Clinical Trials Office. 

3. Imaging
i. Center for Image Acquisition
The Center for Image Acquisition, part of the USC Mark and Mary Stevens Neuroimaging and Informatics Institute, houses MRI equipment used for neuroimaging. The Center has other equipment to help PIs conduct scans that ensure the comfort for participants. Click here for a full list of equipment and capabilities. 

CRCs can schedule appointments with the Center by creating an account under the “For Investigators” tab. The following information will be needed for the application: project name, proposal number, PI name, anticipated start date, copy of IRB approval letter, copy of study budget showing scan costs. Once the application is approved, login credentials will be provided, and users will be able to schedule online. Investigators preparing budgets for new proposals should contact the center to obtain the latest rates for scans and other services. Please allow at least 2 weeks for rate requests to be approved. 

CIA: Direct any questions to CIA@ini.usc.edu.

ii. Molecular Imaging Center – Radiochemistry/Cyclotron Labs
The Molecular Imaging Center (MIC) is a comprehensive imaging program focused on the development of various types of PET tracers used for imaging disease. The facility includes a Cyclotron GMP facility, PET radiochemistry laboratories, access to small animal imaging, and access to clinical PET/CT imaging facilities.
PIs interested in utilizing these services should contact Peter S. Conti, MD, PhD to set up an initial meeting to discuss the feasibility of the study, the radiotracer availability/preparation and clinical trial enrollment. Clinical imaging studies will be performed under pre-IND, IND, or approved drug protocols at HCC-I. Opportunities for early-phase clinical trials and multi-center trials are available at MIC including existing trials in the following areas:

Oncology:
● Breast Cancer
● Prostate Cancer

Neurodegenerative Disease:
● Alzheimer’s Disease
● Parkinson’s Disease

Cardiovascular Disease:
● Cardiac Ischemia

MIC: Peter S. Conti, MD, PhD. 323-442-3858 / peter.conti@med.usc.edu and copy miclab@usc.edu.

4. Cardiology & CardioVascular Thoracic Institute 
Echocardiography services are available at the CardioVascular Thoracic Institute (CVTI), Keck Hospital of USC, and LAC+USC Medical Center. The Echo Core Lab can accommodate orders that are more complex.

The CVTI can accommodate outpatient research-related cardiovascular tests such as echocardiograms, electrocardiograms, or vascular ultrasound. As part of each trial, the CTO will develop a standard ROF that includes an echocardiogram request. That form should be submitted to CVTI at the time of research echo request. 

For inpatient researcg, echocardiograms can be ordered through Cerner like a regular echocardiogram. In the comments section for the order, input "research" and specify which study so that techs know how to modify echo as needed. If the study would be done for clinical purposes and is not being done for research purposes only, the comment is not necessary.

If the study calls for a regular echo, then staff will do a regular echo. If more complex echos are needed, details will need to be provided in order to educate staff in advance.  
How to request service: The PI or study team should contact one of the individuals listed below during the planning process in collaboration with IRB and CTO. The PI or study team will provide protocol, examination details and proposed CPT codes related to the type of echocardiogram needed to fulfill the study and budgetary requirements. The study team should ensure that CTO budgets adequately for the echocardiogram and develops an appropriate research order form. Information on expenses can be accessed via the USC CTO.

The same process for incorporating research echocardiograms into the budget and research order forms applies to studies performed at LAC+USC Medical Center. The PI and study team should be aware that properly budgeted research echocardiograms can be performed at CVTI or Keck Hospital as long as a research order form is completed. If the echocardiograms must be performed at LAC+USC Medical Center and will require a large number of studies on a regular basis, please contact CRU to discuss.
If an inpatient echocardiogram is ordered for research purposes, it will usually be done like any other inpatient echocardiogram. If the echo is urgent (i.e., must be done within 24 hours), then a phone call should be made to the echo lab to make sure it gets done when needed.

CVTI: Clinic Manager Elizabeth Vela elizabeth.vela@med.usc.edu. Click here for additional CVTI staff and faculty contact information.

i. Echo Core Lab
In addition to the standard echo orders and reads, another option for cardiology services is the Echo Core Lab. This resource is available for researchers who require echo reads that require measurements that are particularly complex and outside of the standard echo report. The Echo Core lab is experienced in reading echos for large multicenter trials to ensure standardization and quality. They are available to serve as the echo core lab for IITs and industry sponsored trials conducted at USC.

How to request service: Click here for additional contact information for USC Cardiovascular Medicine

CRU: USC Cardiovascular Research Unit (CRU)
323-442-6863 / fax: 323-442-7610
cru@med.usc.edu.

5. Ophthalmology
The Ophthalmology Clinical Trials Unit at the USC Roski Eye Institute conduct a wide range of clinical trials through a variety of subspecialty services, providing comprehensive ophthalmic exams and diagnostics. Subspecialties include: Cornea and External Diseases, Glaucoma, Oculo-facial Plastic Surgery, Neuro-Ophthalmology, Ocular Oncology, Uveitis and Ocular Inflammation, Retina, Vitreous, and Macular Diseases.

Each ophthalmic examination conducted by the Ophthalmology services will include a broad spectrum of ophthalmic evaluations. The exams may vary depending on the specifics of each clinical trial. A typical exam may include the following: Patient history, visual acuity, depth perception, color vision, eye muscle movements, peripheral vision, pupil response, refraction, tonometry (eye pressure), external examination (cornea, eyelids, conjunctiva), retinal examination/funduscopy (retina, optic disk, macula). The USC Roski Eye Institute offers the most advanced diagnostic technologies through their on-site services. For more information about the wide-range of diagnostic testing that may be conducted in each clinical trial, see below.

How to request services: Ophthalmology service for clinical trials may be accessed through the following procedure:
1. The requesting department PI or CRC should initiate contact with the ophthalmology clinical trial unit by calling 323-865-6935 or by completing our online contact form. For more information on ophthalmic clinical trials click here.
2. The scope of the trial and needed services should be presented through a Research Order Form (ROF), schedule of visits, and instructional documentation related to the requested services.
3. Charges should be obtained through the ophthalmology charge master on file with the CTO.
4. A full review by the ophthalmology PI and ophthalmology clinical trial unit will be conducted with feedback on available resources and clinical registration procedures.
Click here for contact information for the Department of Ophthalmology.

Ophthalmology CTU:
323-442-6335 / fax 323-442-6496
Yoon Hee Kim, Research Coordinator Supervisor Yoonhee.Kim@med.usc.edu.

6. Neurodiagnostic Department of USC Comprehensive Epilepsy Center
The USC Comprehensive Epilepsy Center is designated as a level 4 epilepsy center, indicating that the center and its associated staff can provide care for the most complex cases. The Neurodiagnostic Department can provide services such as electroencephalography (EEG). Specifically, routine, sleep-deprived or video EEGs are available for the purposes of diagnosing epilepsy or brain abnormalities. For more information and to coordinate services, reach out to the department directly.

Neurodiagnostic Department:
https://epilepsy.keckmedicine....

7. USC Sleep Disorders Center
The USC Sleep Disorders Center provides inpatient and outpatient sleep disorder evaluations. In addition to providing treatment for a variety of sleep disorders, the center also can be used as a location to conduct sleep assessments as part of a research study. The center includes a four-bed sleep lab and is staffed by board-certified sleep specialists and registered polysomnography technologists. For more information and to coordinate services, reach out to the center directly.

Sleep Disorders Center: sleepcenter@med.usc.edu

8. Pulmonary Diagnostic Services Lab
The Pulmonary Diagnostic Services Lab provides assessments that test pulmonary function, such as lung function evaluation, supplemental oxygen evaluation and bronchospasms evaluation. For more information and to coordinate services, reach out to the lab directly.

Pulmonary Diagnostic Services Lab: KeckPFTLab@med.usc.edu  

9. Dermatology
The providers at USC Dermatology possess clinical expertise in the management of rare and common skin diseases like psoriasis, atopic dermatitis, skin cancer, infectious diseases, autoimmune diseases and immunobullous diseases. Clinical dermatologic services that pertain to research patients can include skin biopsies, cyst removal and Mohs surgery. For more information and to coordinate services, reach out to the department directly.

Dermatology: dermatology@med.usc.edu

10. USC Clinical Trials Unit 
The Clinical Trials Unit at USC (CTU) provides the infrastructure, resources, and support to conduct human studies, with a focus on early phase and complex mechanistic trials. CTU can assist study teams with accommodating patient visits for high intensity trials that involve serial blood draws, infusions, and monitoring. The CTU also has trained clinical staff like research nurses, phlebotomists, radiology technicians, and more. The staff is highly experienced in collecting and processing PK and PD samples in a timely and efficient manner.

CTU: Yolanda Gutierrez, Assistant Director for Clinical Research Operations; 323-865-3056; cerda@med.usc.edu or ctu@sc-ctsi.org

The CTU also offers a specimen-processing center that offers a variety of services and serves as a one-stop unit for processing, storing, and shipping research samples collected from research patients. The USC CTU has the capability to provide X-ray absorptiometry (DEXA) for body composition or bone densitometry studies. The CTU also provides specimen collection and processing services that may include: blood, saliva, sputum, urine, stool, hair follicles and other types of specimens. In addition, the CTU Processing Center can perform specialized processing for studies in which the assays are run in the investigator’s lab, research core lab, or sponsor’s central lab. Specimen processing may include the following: Serum/plasma separation, buffy coat separation, custom labeling, centrifuging, aliquoting, blood smear, PBMC separation; assistance with shipping & handling (ambient, refrigerated, dry ice). To learn about CTU’s full capabilities, click here.

CTU Laboratory: Lilit Baronikian, CTU Lab Supervisor, 323-865-3379 (office) or 818-642-4838 (cell), yegiyant@med.usc.edu

11. Diabetes & Obesity Research Institute
The USC Diabetes & Obesity Research Institute (DORI) is a multi-disciplinary collaborative of investigators seeking to link basic, clinical, and public health research to advance the understanding of obesity and its relationship to type II diabetes. DORI operates a clinical research facility in the Clinical Sciences Center that supports outpatient studies of low to moderate intensity, such as interviews, medical histories and physical exams, single and multiple blood draws, and oral glucose tolerance tests. Protocols require participation by study teams; additional research nursing and phlebotomy assistance is available through DORI. Special capabilities include dual energy X-ray absorptiometry (DEXA) for body composition or bone densitometry studies performed by an experienced DEXA technician and a core lab that can be used by study teams to perform sample processing following training and approval by DORI staff members, and a metabolic kitchen and gym for nutritional and exercise interventions and assessments. DORI also has a Nutrition Data System for Research (NDSR) program that is used for dietary analysis and available to share with other PIs. Facilities and services are provided at a cost to PIs and their study teams. 

DORI: Christina Ayala, DORI Project Manager, trujillc@usc.edu, 323-442-2500.

Research facilities and core laboratories at HSC support research conduct through services in areas like high performance computing, genomics, cellular and molecular analysis, biomedical imaging, nanoscience, and data analysis and management. Core laboratories offer shared-use research facilities and provide technological support for research projects carried out by faculty across academic disciplines and clinical specialties. 

1. Pathology
The point of entry for all human biospecimen procurement needs is the Translational Pathology Core Facility (TPCF) of the USC/Norris Comprehensive Cancer Center, including whether for clinical trials, non‐interventional translational research studies, basic research studies, and whether cancer‐related or not. In this capacity, the TPCF works closely with the hospital‐based employees of the LAC+USC Medical Center and the Keck Medical Center to facilitate the process of research tissue acquisition and processing and to insure compliance with federal, state, and local hospital regulations. The activities of the TPCF are supported by chargebacks to the study PI. Any investigator may request services from the TPCF, and Cancer Center members receive services at a discounted rate. Specimens can be obtained by USC investigators with IRB approved, funded studies with a valid Lab Agreement.

For all research studies requiring the use of human biospecimens, including both clinical trials and non‐interventional (non‐clinical trial) translational research and basic research studies, after funding and IRB approval have been obtained, investigators must submit one form (the Laboratory Agreement Request Form) in order to obtain approval to procure biospecimens. Once the Lab Agreement is approved, the investigator will meet with Pathology to arrange the implementation of the biospecimen procurement, processing, and distribution required by the protocol. 

For clinical trials, once the trial is opened, two additional forms will enable investigators to request procurement from individual patients: Request for Formalin Fixed Paraffin Embeded (FFPE) Slides/Tissue Blocks and/or Request for Fresh/Frozen Tissues can be obtained from and submitted to Ms. Chen. 

Types of human biospecimens available for research: 
1) Formalin-fixed, paraffin-embedded (FFPE) tissues: 
All tissues taken during clinical care are saved for a period of time in the hospital archives in the form of FFPE blocks. These can be used for research purposes provided appropriate consent and IRB approval have been obtained. At Keck Medical Center, these tissues are stored indefinitely. At LAC+USC, the FFPE tissues are stored in the hospital archives for 10 years, at which point they are donated to the Population Based Tissue Arm of the TPCF (Wendy Cozen, DO, director). TPCF personnel can assist with procurement and sampling (e.g., sectioning, coring) of FFPE blocks in the hospital archives. 
2) Fresh, fresh/frozen, and fluid specimens (e.g., whole blood, serum, plasma, buffy coat, and urine):
Fresh, fresh/frozen and fluid biospecimens can be collected prospectively for IRB approved, funded studies with a valid Lab Agreement and patient Informed Consent. Typically both tumor and matched normal tissue are collected immediately after explanation under the supervision of the service pathologist/PA. The TPCF personnel will assist with the immediate processing and storage of the specimens, banking, tracking, distribution, and processing of specimens required for analysis.

Pathology: List of contacts for the service/core, click here or email Sue Ellen Martin, MD, PhD, director; sue.martin@med.usc.edu

2. USC Clinical Laboratories
The clinical laboratory supports research endeavors by providing information and services to approved protocols. It encompasses Keck Hospital, Norris Hospital, USC Clinical Laboratories Clinical Sciences Center, USC Westside Norris Lab, USC Clinical Lab in Pasadena, KH Newport Beach, the Newport Beach Clinic, and the Huntington Beach Lab.  An approved lab agreement must be on file, and a laboratory agreement and utilization worksheet need to be completed, signed by the PI, and submitted for review and approval to the Pathology Department (addressed to Susan McCarthy). Research protocols require copies of clinical laboratory licensure and accreditation be provided to them. Some research protocols request that testing be performed in the clinician’s office or other area (Point of Care testing), outside the knowledge of the USC Clinical Laboratory. Notify the laboratory if you are performing any testing (including dipstick, urine pregnancy, glucose, hemoglobin, INR or other tests) within your area that is a part of the research protocol. 

USC Clinical Laboratories: Initiate Lab Agreement: Susan McCarthy, Chief Administrative Officer at susanmcc@med.usc.edu

Regulatory Information: Marianne Silva; Manager of Quality, Regulatory Compliance at USC Clinical Laboratories; 323-442-8583 Marianne.Silva@med.usc.edu

3. Other Core Laboratories & Facilities
Other labs and facilities within USC, Keck, Norris, and CHLA can assist with processing specimens and cells (in areas such as genomics, flow cytometry, stem cells, molecular and cell biology, etc). For a complete list, click here.

Other Laboratories and Facilities: If you are having trouble identifying a laboratory or facility to assist with processing, please contact SC CTSI Clinical Research Support at crs@sc-ctsi.org


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NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.