Starting a Clinical Trial: the Basics

Diagram of Clinical Trial Workflow

This quick guide to clinical trial resources is designed to provide information for the initiation and conduct of clinical research at USC. This information includes descriptions of email accounts, training, electronic systems, and offices integral to clinical research.

This document is intended to describe processes for clinical research conducted at USC and at LA County+USC, and not at Children’s Hospital Los Angeles (CHLA). Consult CHLA for information about their processes.


Email Account Set-up

All USC faculty, staff and students are assigned a USC NetID account, also known as Shibboleth or enterprise account. This is essential to access systems in the university (however, the IRB submission system, iStar, mentioned below, requires a separate log-in).

Some USC schools and departments maintain additional local systems such as Health Science Campus’s Medmail. Contact your departmental administrator to determine exactly which accounts you will need to activate.


Pre Award Financial Management

At USC, clinical trials are managed in two different workflows depending on whether the funding source is

industry (corporate sponsorship) or non-industry (federal monies, foundations, or grants). New trials

should be directed to either the CTO or DCG (see below),  according to the funding source. An MCA (Medicare Coverage Analysis) is required for most industry and non-industry trials, which means that while DCG will handle the contract, the CTO will need to complete the MCA.


Clinical Trials Office (CTO)

Clinical Trials Office(CTO) manages industry funded clinical trials. All industry sponsored clinical research and studies that will incur healthcare facilities billing must be submitted to the Clinical Trials Office. CTO provides Medicare Coverage Analyses (MCA), budgeting, contracting and sponsor relations for clinical trials. CTO will complete an MCA for non-industry clinical trials. CTO initiates the budget and contracting process through OnCore.

OnCore – Clinical Trial Management System

All industry sponsored trials and studies that will incur healthcare professional fees and/or facilities billing must be submitted to OnCore, the Clinical Trial Management System (CTMS). OnCore is a web-based software system used for managing industry sponsored clinical trials. OnCore is maintained by the OnCore Support team of the Clinical and Translational Science Institute.

OnCore Training and Support Information

OnCore Login


Department of Contracts and Grants (DCG)

With the exception of industry sponsored clinical trials, all contract and grant proposals at USC must be submitted to the USC DCG, after proposal and budget preparation by the investigators’ school(s). The CTO maintains responsibility for Medicare Coverage Analyses (MCA) for non-industry as well as industry trials.

Department of Contracts and Grants Contact information


Systems Supporting Research Administration

USC utilizes on-line systems for most research administration processes, in addition to OnCore:

Total Access for Research Administration (TARA)

TARA is the portal linking to research administration systems at USC. With the exceptions noted below, TARA does not support research conducted at Children’s Hospital of Los Angeles (CHLA).

KualiCoeus (KC)

KC supports proposal routing/approval, establishment of awards, and tracking of negotiations. School approval is required within KC for all grant proposals.

diSClose

diSClose is a system for USC Employees to disclose any possible conflicts of interest. Any outside financial relationships with pharmaceutical or device companies must be disclosed in diSClose regardless of whether research is involved.
Researchers who are proposing or have received support from the US Dept of Health and Human Services (including NIH, CDC, HRSA, and AHRQ) must also make an annual disclosure of all financial interests related to their institutional responsibilities to USC, regardless of whether any of these interests give rise to a conflict of interest related to their research.

iStar

iStar is the system for review and research compliance of human subjects research, animal research, radiation safety and biosafety. The human subjects component of iStar is used both at USC and CHLA. iStar is a web-based IRB application by which the Institutional Review Board (IRB) reviews submissions for initial and continuing approval. IRB submission and approval are required before recruitment can begin.

Obtain an iStar Account
Instructions for iStar and CITI


ClinCard – participant compensation

If compensation will be provided to study participants it must be made in the form of a ClinCard (debit card) in lieu of cash. The ClinCard web-based system provides the management for subject compensation. Clincards are managed by the USC Business Services, and are ordered through eMarket.

ClinCard Services

ClinCard Contact Info:

Gabe Ariza
(213) 740‑6015
prepaidcards@usc.edu


Training and Certification

Investigators and staff who engage in clinical research are required to complete courses specific to their responsibilities in research. The following links provide instructions for registration and training certifications. Additional training may be required by certain offices or sponsors:

IRB Required Courses

HSR-Human Subjects Research Protections
GCP – Good Clinical Practices
HIPAA – Privacy Rule for Protected Health Information

Clinical Research Coordinator Basics Course

Clinical Research Coordinators – CITI course

Grants Management Training

Grants Management Training for Faculty (required prior to first award at USC)
Grants Management Training for Staff

Research Training Finder

The Research Training Finder determines the courses required for specific positions.

Study sponsors may require and provide additional training.


Research Support Offices

Southern California Clinical and Translational
Science Institute (SC CTSI)

The SC CTSI is a research institute of the University of Southern California (USC) and Children’s Hospital Los Angeles (CHLA).
Its goal is to translate scientific discoveries into solutions for better health.

The SC CTSI provides help with biostatistics, clinical research informatics, training and education, community engagement, team building, and funding for projects.

Clinical Research Support offices at USC and CHLA assist with research navigation, budgeting and contracting, study coordination, participant recruitment, and regulatory advice.

The Clinical Trials Unit (CTU) supports complex, high-risk trials and provides ad hoc services such as blood sample acquisition and processing.

SC CTSI activities include:

DEWARS (data warehouse)
Training grants
Community engagement
Clinical studies directory

SC CTSI Contact Info:

sc-ctsi.org
info@sc-ctsi.org
(323) 442-0217

Clinical Investigator Support Office (CISO)

CISO is the clinical research infrastructure assisting investigators with the conduct of all cancer trials for which USC Norris Comprehensive Cancer Center is a Lead Academic Participation Site. This includes oncology trials at LAC+USC Medical Center and Children’s Hospital of Los Angeles (CHLA). As one of the original eight NCI-designated Comprehensive Cancer Centers, USC Norris’s Clinical Investigational Support Office has been managing clinical trials for over 20 years.

All cancer studies are required by the National Cancer Institute (NCI) to be overseen by CISO; studies that include cancer patients as a sub-population and not the main focus/objective of the research may not be required to be submitted to CISO. Contact CISO to discuss how this requirement applies to any specific study.

CISO Contact Info:

uscnorris.com/ciso

(323) 865‐0451

Office for the Protection of Research Subjects

The Office for the Protection of Research Subjects (OPRS) operates under the direction of the Vice President of Research. OPRS is responsible for establishing the IRB policies for USC as well as identifying and implementing best practices to ensure continued USC accreditation. Additional responsibilities include oversight of USC IRBs as well as providing education to the human subjects research community.

OPRS Contact Info:

oprs.usc.edu

(213) 821-1154

Office of Research

The Office of Research is responsible for all aspects of research administration, research ethics and research advancement for the university. The office invests in research initiatives, encourages sponsored-research, and provides resources to promote high ethical standards in research.

Office of Research Contact Info:

research.usc.edu
vice.president.research@usc.edu
(213) 740-6709


IRB and Ancillary Committee Review

Clinical trials at USC require IRB approval as well as approval from specific research committees depending on the materials and methods of the trial.

IRB Review

An Institutional Review Board (IRB) is a committee established at institutions or organizations where human subjects research is conducted or supported.
The IRB is charged with reviewing, approving and monitoring research projects involving human subjects for compliance with institutional policies and state, local, and federal laws. The committee includes faculty, staff and members of the community who review and oversee protocols. USC has separate IRBs on the Health Science Campus (HSC) and University Park Campus (UPC). The three IRBs at HSC review clinical research and the IRB at UPC reviews social-behavioral research. The IRBs also serve the function of HIPAA Privacy Board.
How to Get IRB Review
HIPAA Requirements
HIPAA Research Authorization Form

Ancillary Regulatory Committees

Depending on the nature of the research, additional regulatory committee reviews and approvals may be required before the IRB approves a research protocol. Other research regulatory committees are:

Radiation Safety Committee
Institutional Biosafety Committee
Clinical Investigations Committee
Stem Cell Research Oversight Committee
Institutional Animal Care and Use Committee
Conflict of Interest Review Committee


Clinical Services

USC Laboratories and Services

There are over 60 research laboratories and services located at the University of Southern California main campus (UPC), Health Science Campus (HSC), and Children’s Hospital Los Angeles (CHLA).
Laboratory services include hematology, radiology, materials imaging, flow cytometry, histology and pathology, spectroscopy, cell culture and analysis.

USC Laboratories and Services
Keck School of Medicine USC/Pathology
Research Lab Utilization Worksheet 2016
Laboratory License and Related Documents Request Form
Department of Radiology

Research at Los Angeles County + USC Medical Center

USC and LAC+USC have established procedures for the conduct of clinical research including billing and approvals for research services conducted at LAC+USC.
For more information, visit Research at LAC


Drugs, Devices and Biologics:
Receipt, Distribution and Disposition at USC

Investigational Drug Services (IDS) for Drugs & Biologics

Research involving any investigational drugs or biologics is the responsibility of the USC IDS Pharmacy. Investigational drug or biologics receipt, accountability, storage, compounding, dispensing and disposition are managed in compliance with the FDA, industry sponsors, State and Federal Regulations. This responsibility applies to research conducted at any of these facilities:

  • Keck Hospital of USC
  • USC Norris Cancer Hospital
  • Clinical Trials Unit at Norris
  • Outpatient clinics
  • LAC+USC Medical Center
  • Maternal Child and Adolescent Research

IDS Contact Information:

IDSPharmacy@med.usc.edu
(323) 865-3538

Investigational Device Services:

The use or study of devices must be cleared for safety and hazard potential by Keck and Norris Hospitals purchasing departments prior to being used in a study. A purchase order must be obtained, even if the sponsor is providing the item free of charge. In order to comply with State and Federal regulations and accreditation requirements, no piece of equipment, device or supply may be brought directly into the hospital. Everything must be received through hospital materials management.
All vendor representatives must be registered and must sign in daily through Reptrax. Any person who is not an employee or faculty of Keck or Norris Hospital must obtain permission to be on premises. This is accomplished by contacting:

Keck Hospital Medical Staff Office
(323)442-8686

Persons entering the OR and/or contacting/observing a patient must have proof of negative TB test. From October 1 through March 31, persons contacting/observing a patient must provide evidence of flu vaccination. There are no exceptions to these health clearance requirements.

For questions regarding supplies and materials, please contact:

Lilia Stanfill
Manager, Materials Management
lilia.villalobos-stanfill@med.usc.edu
(323) 865-9980

For questions regarding hospital operations and logistics, please contact:

Ellen Whalen, RN, DRSc
Associate Hospital Administrator
ellen.whalen@med.usc.edu
(323) 442-8396


FDA Responsibilities: Drugs, Devices and Biologics

The Food and Drug Administration regulates all drugs, biologics and devices whether used for investigational purposes or seeking approval for marketing.

In order to conduct a clinical investigation of a drug, biologic, or device, FDA must approve the research use. For an investigational new drug an IND application is required. For an investigational device an IDE application is required. The FDA may determine the research use is exempt.

In most cases, the clinical trial sponsor files the IND(Investigational New Drug Application) or IDE(Investigational Device Exemption). In cases where an investigator holds an IND or IDE the investigator assumes the responsibilities of both an investigator and a sponsor. The following documents will be helpful in conducting a clinical trial involving FDA regulations:

Responsibilities of Sponsor-investigators
NIH Research Toolkit
NIH Regulatory Binder Checklist

Investigational Drugs and Biologics

An Investigational New Drug (IND) application is the document submitted to the FDA for permission to conduct a clinical study using a drug or biologic that is new or being used for an unapproved dosage, formulation or indication.
If a study does not require an IND, the investigator must provide the IRB with an FDA determination of IND exemption.

Investigational Devices

An Investigational Device Exemption (IDE) application must be submitted to FDA to allow for the conduct of a clinical study using a significant risk device that is new or not approved for a given use. (A significant risk device presents a potential for serious risk to the health, safety, or welfare of a subject.

If the investigation involves the use of a device that does not pose significant risk to humans (a non-significant risk device), an IDE application to FDA is not required. Submissions for non-significant risk devices are made directly to the IRB. The sponsor-investigator must explain to the IRB why the device does not pose a significant risk.


Post Award Financial Management

CTO

The Clinical Trials Office is responsible for post award financial management for all industry sponsored studies. This includes working closely with study teams on account establishment, invoicing, collection and generally helping ensure appropriate management of industry funds.

Sponsored Projects Accounting

Sponsored Projects Accounting (SPA) manages the post-award financial management of non-industry clinical trials. This includes working closely with study teams, school administration and DCG on tasks such as account establishment, letter of credit drawdowns, invoicing, collection, payment application, expense transfers, financial reporting (if applicable), and generally helping ensure appropriate management of sponsored funds.


Regulatory Documents Binder

A regulatory binder is a set of records maintained for each clinical trial. The documents include all submissions and communications with the IRB and other ancillary committees, investigator brochure, and protocol. The following documents are commonly required in the study binder:

Responsibilities of Sponsor-investigators
NIH Research Toolkit
NIH Regulatory Binder Checklist

USC IRB Membership Rosters

The lists of members on the USC Institutional Review Boards are periodically updated and posted on the following sites.

Health Science IRB
University Park IRB

Federalwide Assurances (FWAs)

The University of Southern California maintains assurances of compliance, called Federalwide Assurances (FWAs), with the Office for Human Research Protections (OHRP) in the US Department of Health and Human Services (HHS). The University is required to enter into this agreement because it receives federal funding for research involving human subjects. It is an assurance that USC follows a statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research.

USC FWAs

Certificates for Required Training

Copies of the certifications obtained for all required training will be filed in the regulator binder. Examples include:

Good Clinical Practice Training
Human Subjects Research
HIPAA
Grants Management

21 CFR Part 11 Compliance Statement

The following documents ensure that the USC’s iStar system and the Keck Medical Center electronic medical records system are compliant with FDA Part 11.

iStar system (8/27/13)
iStar electronic signature (8/27/13)
EMR Part 11 Keck Medical Center (3/31/16)

USC Emergency Management and Business Continuity Plan

The emergency management and business continuity plan support USC’s central mission of teaching, research, and service by preparing schools and departments to resume critical operations rapidly following a disaster. The university maintains backup and recovery plans to protect against the loss of vital data due to an adverse event or disaster. The following links are provided to USC Emergency Management, Business Continuity and IT Disaster Recovery policies:

USC Policy Emergency Management
USC Business Continuity and Disaster Recovery
USC Norris Comprehensive Cancer Center Business Continuity and Disaster Recovery Plan

Clinical Trials Must Be Registered to ClinicalTrials.gov

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical research studies. Registration of clinical research studies is required by law prior to study enrollment.
Protocol Registration System (PRS) is the Clinicaltrials.gov system used to register and update studies.

HHS has expanded the legal requirements for registering and submitting results for clinical trials involving FDA-regulated drug, biological and device products. National Institutes of Health has issued a complimentary policy for all NIH-funded clinical trials including phase 1 studies and clinical trials of behavioral interventions.

For help registering USC non-cancer trial, contact:

Jean B. Chan, Associate Director
Dept of Contracts & Grants
jeanbcha@usc.edu
(323) 442-2825

For registration of USC cancer trials contact:

Vicky Soto, Project Specialist
Cancer Center- Clinical Investigator Support Office
victoria.soto@med.usc.edu
(323) 409-4359

Additional Support and Information:

HHS News Release
NIH Definition of Clinical Trial Decision Tree
ClinicalTrials.gov Registration Instructions