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Researcher Resources

Set Up Study

What should I do before enrolling study participants?

  1. Prepare Proposal & Apply For Funding
  2. Set Up Research Budgets & Participant Billing
  3. Sign Up for Resources & Clinical Services
  4. Initiate Regulatory Tasks
  5. Complete These Tasks before Enrolling Study Participants

For detailed information, open the color-coded items below this key.

CTSI users receiving services are required to:
  • Cite the CTSI grant UL1TR001881 in CTSI-supported research.
  • Complete periodic CTSI surveys

GUIDANCE - Consult with a Study Facilitator

CTSI provides Research Facilitators who connect investigators to the resources needed at any stage of the clinical research process.

    Contact your site Research Facilitator

Funding Opportunities

UCLA CTSI Pilot Grants

UCLA CTSI provides pilot funding to support clinical and translational research in a number of areas, with opportunities to apply year round. Pilot grants are administered by UCLA CTSI under the guidance of the CTSI Pilot and Collaborative Translational and Clinical Science Program.

CTSI funding opportunities

Pediatric Funding Opportunities

Other Resources for Funding Opportunities

Grant Proposal Preparation and Submission

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Investigator Roles and Responsibilities

UCLA Office of Contract & Grant Administration (OCGA) assists UCLA campus research enterprise in the process of applying for, accepting, and administering contract and grant awards.

CTSI Assistance with Proposals

CTSI Rapid Response Team provides grant proposal management software and assists investigators with brainstorming sessions. RRT also facilitates large team science proposals by supplying administrative support to collect supporting documents such as biosketches, letters of support and resources and facilities boilerplates.

CTSI Partners' Institutional Facts

UCLA Office of Contract and Grant Administration provides institutional facts in their Proposal Tool Kit such as:

  • Basic Elements of a Proposal
  • Commonly Needed Information (Institutional Tax ID, Accreditation, etc)
  • UCLA Employee Benefit Rates
  • UCLA Salary Projections
  • Indirect Cost Rates
  • General Liability Assessment Program Costs

Boilerplate Text for Grant Proposals

Boilerplate text describing CTSI partner site institutions, programs, data repositories and more are available for use in your grant proposals.

Boilerplate text is available for the following categories:

  • CTSI and partner institutions
  • CTSI program areas
  • Clinical and Translational Research Centers
  • Research Cores
  • Regulatory
  • UCLA schools, departments, institutes and centers
  • UCLA hospitals and health system
  • Incubators, licensing and entrepreneurship
  • Research Data Repositories

Clinical Trials

Biomedical Informatics or Biostatistical Assistance for Your Proposal

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CTSI Biomedical Informatics Program (BIP) consultants will help review your project's data management and informatics needs and assist with developing a budget, the biomedical informatics proposal section for your grant prior to submission.

CTSI Biostatistics Program offers the following grant preparation services:

Grant Preparation

  • Study design and power analysis
  • Data analysis protocols
  • Career development (K series) applications

The CTSI Biostatistics Program also offers a free one-hour consultation for help with all aspects of study design, including biostatistics and data collection.

Drop-in Consultations

UCLA:
Every Wednesday
, 12pm-1pm,
Life Sciences Bldg, Room 5229
Every Friday, 3pm-5pm,
911 Broxton building, 3rd floor
- See flier for services.

LA Biomed-Harbor:
By arrangement with Dr. Youngju Pak
Contact: ypak@labiomed.org
Website:research.labiomed.org/biostat
Phone : 310-222-1874, fax: 310-533-1874
Office: LA BioMed/Harbor-UCLA, RB-1, Rm. 248

Support for Research Budgets

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See the below resources to get more information on how to approach budgeting and billing on clinical research projects.

UCLA

Clinical Research and Clinical Trial activity at UCLA involves coordination of many areas and departments within the Medical Sciences enterprise and on the UCLA campus. The Office of Compliance Services created resources for the research community as it relates to conducting research in a responsible manner and in compliance with the applicable federal and state laws and regulations.

Research Participant Billing for CTRC Studies

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CTRCs

The CTSI Clinical and Translational Research Centers (CTRCs) at UCLA-Westwood, Cedars-Sinai, Charles R. Drew University and LA BioMed/Harbor-UCLA, provide budget and billing support to faculty conducting research at the CTSI partner sites (Cedar-Sinai Medical Center, Charles R. Drew University, Harbor-UCLA at LA BioMed and UCLA).

UCLA

Clinical Research Billing for the CTRC
Clinical Research and Clinical Trial activity at UCLA involves coordination of many areas and departments within the Medical Sciences enterprise and on the UCLA campus. The Office of Compliance Services created resources for the research community as it relates to conducting research in a responsible manner and in compliance with the applicable federal and state laws and regulations. More »

Government Resources

Key Points

  • Keep accurate, complete, up-to-date records (including enrollment status).
  • Review and return billing reports in a timely manner.

Tips for Staffing Your Clinical Research Study

An essential step in clinical research, after you've secured funding and established the parameters of your project, is organizing a staff that will enable you to conduct the study. If you're already working in a clinical setting, you'll most likely have a staff of health care professionals and administrators to assist you with patients. However, if you don't have access to these resources, you'll need to carefully consider your staffing needs. The first step is to determine the type of staff you need.

What does a research coordinator do?

The duties of a research coordinator may include:

  • Serve as a liaison between the sponsor/CRO (contract research organization), PI, patients and IRB
  • Submit regulatory documents, revisions and renewals to the IRB
  • Advertise for, screen, consent, enroll, and randomize patients
  • Schedule patient visits and tests
  • Conduct study visits with patients
  • Track and document adverse events
  • Compile source documents
  • Fill out required logs and case report forms
  • Follow GCP (good clinical practices) and ICH (International Conference on Harmonization) guidelines for research on human subjects
  • Communicate effectively with the study team to address queries
  • Attend investigator meetings and coordinate monitoring visits

Do you need a registered nurse?

For many clinical studies, having an RN on staff is essential because you'll need someone with a solid health care background who can perform some medical procedures. If your research project involves an experimental drug or medical device, you'll need someone who can watch for possible adverse events and who is knowledgeable about the risks and benefits to the study participants. You'll also need someone who can communicate effectively with participants and be able to explain or discuss the nature of the study with someone who doesn't have a medical background.

In some cases, a licensed practical nurse, someone with medical training, or someone with research experience might suffice, but to independently monitor and assess study participants, you'll need a research nurse.

Do you need a research coordinator?

A research coordinator or a data manager can be very helpful additions to your staff. While a data manager can assist in maintaining data records and ensuring continuity in data collection, a research/clinical coordinator can provide valuable assistance in recruiting and screening study participants or in carrying out certain elements of the research project. Research coordinators can also help with management of the Regulatory Binder and consenting of patients for less medically complex protocols. Some research/clinical coordinators have phlebotomy certificates which allow them to help with blood draws if needed.

Are there special staffing considerations for a very large project?

If you're conducting a large clinical research project or find yourself in an especially large clinical setting, you might want to hire staff members specifically to handle regulatory work and clinical coordination. Ensuring that your study is compliant with FDA regulations throughout the project and that IRB submissions are handled properly and on-time can be demanding, especially in the case of a large study; having a person designated to handle such tasks can be a major benefit. This may mean you need a research nurse, a research/clinical coordinator and a data manager.

Decision tree to help investigators in hiring research staff

Investigators are responsible for protecting the rights, safety, and welfare of subjects under their care during a clinical trial (21 CFR 312.60 and 812.100, See FDA Federal Regulations).

The following skills are necessary to help you with your protocol management depending on the complexity of your research protocol and subjects. These will ensure that your study is managed effectively with emphasis on the safety and follow up of your subjects as well as managing the protocol to the highest standard per ICH (International Conference on Harmonization) and GCP (good clinical practice) guidelines.

  • Critical Decision Skills
    • Protocol Management
    • Subject Safety
    • AE (adverse event) management
  • Knowledge Base
    • Recruitment
    • Consenting
    • Education
  • Assessment
    • Screening
    • AE management
    • Subject follow up
  • Extraction and Analyzation and Interpretation of Information/Data
    • AE reporting
    • Management of abnormal values, etc.
    • Source documentation and CRF completion

To help you determine what experience and training your coordinator should have, it is important that you have an understanding of the protocol. The following subject headings will provide you with some guidance to determine the level of complexity that is required based on your subject population and what is being studied.

  • Protocol Complexity
    • Is the Protocol an IND or IDE?
    • Will subjects be consented during routine clinic visits?
    • Does the protocol require multiple follow up visits?
    • Will there be an outside resource used for study related procedures?
    • Are there any procedures that require a licensed nurse?
    • Do the follow up clinic visits require interventions, i.e. vital signs, wound care, lab draws, and study medication administration?
    • Are there multiple protocol related procedures, i.e. labs, EKG, radiology etc
  • Subject Population
    • Healthy volunteers
    • Rare disease
    • Multiple co-morbidities
    • Newly diagnosed disease process
    • Are these subjects with existing chronic illnesses?
    • Are these subjects enrolled in a critical care setting, i.e. ICU/ED
    • What is the emotional status of subject during recruitment and consent process?
    • Age of subject

Location for Study Conduct

  • Subjects residence
  • Clinic or outpatient unit
  • Clinical and Translational Research Center (CTRC)
  • CRC or PI office
    • Inpatient unit
    • ICU
    • ER
    • Medical or Surgical floor
    • Step down monitored unit

Coordination

  • Will screening and follow-up require communication with:
    • Multiple clinicians and other health care providers
    • Outside services and providers
    • Other departments related to clinical care
    • Other departments within institution related to research administration
    • Multiple sponsor related services, i.e. IVRS, coordinating center, CRO, etc.

Education and Communication

  • Will the protocol require other health care providers to receive education/in-service?
  • Will the subject require subject education for compliance of protocol
  • Same list as above under Coordination

Resources for Child Health

UCLA Clinical and Translational Research Centers (CTRCs) offer coordinator and nursing services for child health studies.

UCLA-Westwood: please e-mail Helen Williams-Bayne or phone 310-267-1029 for more information.

Jobs

UCLA CTSI periodically circulates information about new openings in clinical research to a self-identified pool of external job-seekers. From time to time, CTSI is contacted by faculty and department administrators to distribute open clinical research employment opportunities to our database.

Subscribe to the UCLA CTSI e-newsletter email list

If you would like to be added to our newsletter e-mail list, please click here or send your information to editors@ctsi.ucla.edu.

The newsletter that contains an employment section intended only to be a supplement to the CTSI partners’ job posting process.

Policies & Standard Operating Procedures

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State and Federal Policies & Procedures

Clinical and Translational Research Center (CTRC) Standard Operating Procedures

Regulatory & Compliance - Support Services, Resources and QuickLinks

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The Regulatory Knowledge and Support, and Ethics Program services include:

Post-Approval Regulatory Oversight (PARO)

Data Safety Monitoring

  • Develop and review data safety monitoring plans
  • Review data safety monitoring reports
  • Adverse event and incident reporting

Quality Assurance

  • Review data collection forms
  • Monitor studies

Regulatory Requirements

  • Continuing regulatory review and approval
  • Conflicts of interest
  • Clinical trial registration
  • Progress reports

QuickLinks

Submit a CTRC Application

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  • Submit a CTRC application - contact your site below to learn how to submit your application. All CTRC partner site services are available to all CTSI researchers.

What is the Clinical and Translational Research Center application?

The UCLA CTRC online application processes and forms are used at UCLA-Westwood, Cedars-Sinai, Charles R. Drew University and LA BioMed/Harbor-UCLA to submit, review, and approve clinical research services. All CTRC partner site services are available to all CTSI researchers.

See below for the available processes and forms at each site:

UCLA-Westwood CTRC

Cedars-Sinai CTRC

Charles R. Drew University

LA BioMed/Harbor-UCLA

Clinical Trials – Registration Process

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No matter what type of human-subject research investigators may be working on, there are some steps that all should take to enhance patient recruitment. By posting studies on the following four websites, researchers can efficiently find the participants needed to complete projects in a timely fashion.

REGISTER – ClinicalTrials.gov
http://clinicaltrials.gov/

Researchers may post any human-subject study to ClinicalTrials.gov — even observational studies — to benefit from a megaphone of publicity, all underwritten by the National Institutes of Health. ClinicalTrials.gov receives 50 million unique visitors a month, and its clinical trial data is regularly fed onto the Stanford Clinical Trials Directory, patient advocacy websites and the World Health Organization’s trials database, among others. The NIH has recently put more marketing muscle behind this database with the launch of a new website — www.cc.nih.gov/ — to promote clinical trial participation. (Remember that a certain class of interventional studies is required to be listed on ClinicalTrials.gov, and investigators must post these study results on the NIH site within a year after study completion.)

REGISTER – FDA: IND and IDE Studies
http://clinicaltrials.gov/ct2/manage-recs/fdaaa
  • The FDA requires registration.
  • Registration must occur prior to enrollment of the first study participant.
  • Failure to register applicable drug, device, or biologic studies can result in federal fines.
  • Please see the ClinicalTrials.gov Protocol Registration System website.

REGISTER – ICMJE (International Committee of Medical Journal Editors)
http://www.icmje.org/
  • ICMJE requires registration.
  • Registration must occur prior to enrollment of the first study participant.
  • Without this registration, you run the risk of not being able to publish the results of your study.

Clinical Trials – Registration FAQs

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Should you register your research project with ClinicalTrials.gov?

1. YES, if you want your study listed in the UCLA CTSI Directory.

If you want your study to appear in the UCLA CTSI Clinical Trials Directory then you must register your study at the NIH website, ClinicalTrials.gov. The UCLA CTSI Directory only displays California studies that it can pull from ClinicalTrials.gov.

2. YES, if you want to publish the results of your study.

If you wish to publish your study in a peer-reviewed journal, then it is highly likely that that journal will expect your study to have been registered with ClinicalTrials.gov. Over 1,000 journals have adopted the policy of the International Committee of Medical Journal Editors (ICMJE) that requires registration in a publically available register. The list of journals is at this link:
http://www.icmje.org/journals.html

ICMJE requires registration for a wide range of studies. Below is their definition. Please note that almost any prospective study of medical or health interventions in human beings qualifies, including "observational" research.

  • "The ICMJE believes that it is important to foster a comprehensive, publicly available database of clinical trials. The ICMJE defines a clinical trial as any research project that prospectively assigns human subjects to intervention or concurrent comparison or control groups to study the cause-and-effect relationship between a medical intervention and a health outcome. Medical interventions include drugs, surgical procedures, devices, behavioral treatments, process-of-care changes, and the like."

The ICMJE does not require posting of results for studies that are not otherwise required by law to do so.

3. YES, because in some cases, IT’S THE LAW.

A smaller subset of studies are required by law to be registered with ClinicalTrials.gov. The FDA Amendments Act of 2007 (FDAAA) required that most prospective studies involving regulated drugs, biological products, and medical devices must be registered on ClinicalTrials.gov. The law also requires reporting of “basic results” and adverse events for a subset of these studies. If you would like to determine if your study is required by FDAAA to be registered, you can follow the flowchart at this link http://grants.nih.gov/ClinicalTrials_fdaaa/docs/Flow_chart-ACT_only.pdf or contact the UCLA CTSI Regulatory Knowledge and Support, and Ethics Program for assistance.

4. When do I have to register my study?

ICMJE requires that you register prior to enrollment of your first study participant.

The law requires that a study be registered within 21 days of enrollment of the first participant. You must also update your ClinicalTrials.govrecords at least every 12 months, or within 30 days of a change in recruitment status.

5. When do I have to post basic results?

The law requires that a subset of basic information be posted on ClinicalTrials.gov for any study in which the study product is approved for any use. For example, if you are studying an approved drug for a new use, you must register basic results. You must post this information within 12 months of the “Primary Completion Date” – defined by ClinicalTrials.gov as the final data collection point for the primary endpoint. Please note that you may not wait until complete data analysis of your project is completed to post basic results, if such completion falls outside the required time frame.

6. What are the consequences if I don’t register?

The consequences for non-compliance can include rejection for publication in top journals (even for studies not required by law to register), fines from FDA or NIH, or the withholding of grant funds - for you individually or for the entire institution.

FDA Submissions – Devices (IDE)

The U.S. Food and Drug Administration website provides information for regulated industry on determining how to comply with the federal laws and regulations governing medical devices. See their Device Advice: Device Regulation and Guidance page for the following information and more:

  • Overview of Medical Device Regulation
  • Compliance Activities (Medical Devices)
  • Postmarket Requirements
  • Standards

FDA Submissions - Drugs & Biologics (IND)

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The U.S. Food and Drug Administration website provides information for the Investigational New Drug (IND) Application. The site includes information and resources including:

  • Pre-IND Consultation Program
  • Guidance Documents for INDs
  • Laws, Regulations, Policies and Procedures
  • Emergency Use of an Investigational Drug or Biologic
  • Related Resources, including Applications

Required Training for Clinical Research

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  • Questions?

Education, required training and professional growth opportunities are available to the clinical research communities at the CTSI partner sites.

REQUIRED TRAINING

UCLA

  • Collaborative Institutional Training Initiative (CITI)* (Required)
    Required human subjects training for all key personnel who work on research projects (all investigators and other study personnel, including all persons who are responsible for the design, conduct, data analysis or reporting). More »
  • Laboratory Safety Fundamental Concepts (Required)
    Everyone in the UCLA community is required to take some safety training. To clarify what safety training is necessary for each job function, Environmental Health and Safety developed the Training Requirements online tool, including the Lab Safety Training Matrix, for determining what safety training UCLA employees and students needs to take. More »
  • HIPAA Training (Required)
    The HIPAA Research training is a module of the Protecting Human Research Subjects online training site. This site requires registration and login. Questions should be directed to Office of Compliance Services. More »

Recommended Training for Clinical Research

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  • Questions?

UCLA

  • webIRB Training
    webIRB is an online application used at UCLA to submit, review, and approve research (human subjects; stem cells; animal subjects; and biosafety). More »
  • webIRB Education Program
    Basic and Advanced didactic training for webIRB users. More »
  • GCP Training through Office of the Human Research Protection Program
    If you are new to research or just need a refresher course, Good Clinical Practice (GCP) offerings are available through OHRPP. More »
  • Clinical Research Billing
    Clinical Research and Clinical Trial activity at UCLA involves coordination of many areas and departments within the Medical Sciences enterprise and on the UCLA campus. The Office of Compliance Services created resources for the research community as it relates to conducting research in a responsible manner and in compliance with the applicable federal and state laws and regulations. More »

Other Training Resources

next steps

  • Questions?

UCLA

  • CareConnect training – UCLA Electronic Health Record Program
    Training is required for all UCLA Hospital and Clinics physicians and medical personnel who need access to Hospital Medical Records. Training is completed online. The specific courses that you are required to complete are dependent on your specialty, sub-specialty and scope of clinical practice. More »
  • Biomedical Library
    The Louise M. Darling Biomedical Library supports clinical and research clientele on a variety of topics. Unless otherwise noted, sessions are open; no advance registration is required. More »
  • Tech Training
    The Office of Information Technology (OIT) at UCLA provides technology courses. See the ITS website for training options in the classroom and online. More »
  • STAR Program
    The Specialty Training and Advanced Research (STAR) Program at the David Geffen School of Medicine at UCLA is a unique program designed for optimal training of physician-scientists. The program offers the opportunity to combine clinical fellowship or residency training with formal, advanced research training. More »
  • Learning and Development
    Information and awareness of resources for courses, programs, and conferences useful to any staff member for professional development. More »
  • Management Development Programs
    Campus Human Resources, Training and Development provides several programs that enable faculty to build and develop leadership skills. More »
  • Organizational Development (OD) Services
    Organizational Development services assist managers and department heads in designing and implementing solutions to organizational and business needs. Consultation service includes assessment and intervention strategies to improve teamwork and increase productivity. More »
  • UCLA Clinical Trials Administration Office
    The Clinical Trials Administration Office provides the latest news and clinical trials information for the UCLA Jonsson Comprehensive Cancer Center and other departments. More »
  • Office of Intellectual Property and Industry Sponsored Research
    Pre- and post-award administration of sponsored projects to the University. More »

Professional Development

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  • Questions?

PROFESSIONAL DEVELOPMENT

  • ACRP
    ACRP is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings. More »
  • UC Berkeley Extension
    UC Berkeley Extension offers a Certificate Program in Clinical Research Conduct and Management which enables you to master practical aspects of clinical trial conduct and management, including clinical trial phases and design, planning, implementation, data analysis, regulatory and procedural guidelines, and ethical considerations. More »
  • UC Santa Cruz Extension
    The UCSC Extension Certificate in Clinical Trials Design and Management is designed to help professionals gain a solid understanding of the entire clinical trials process, as well as a foundation in the scientific principles, regulations, and ethics that are vitally important to the conduct of clinical research. More »
  • UC San Diego Extension
    Since its inception in 1997, with the help of a highly-qualified and prestigious advisory board & instructors who are cutting-edge industry professionals, UC San Diego Extension’s Professional Certificate in Clinical Trial & Design Management trains professionals at all levels in this vibrant and stimulating field. Students are able to customize their program by choosing an emphasis of study through a grouping of “topics” for a mastery of skills in diverse clinical trial areas. More »
    The UCSD Extension Specialized Certificate in Clinical Trials Administration is modeled on the top-rated UCSD Extension Professional Certificate in Clinical Trials Design and Management, the premier 200+ hour series of courses. The Intensive program consists of more than 100 hours of instruction through two sections, combining classroom instruction as a cohort and distance learning courses to be completed at your place of residence. More »
  • San Francisco State University Extension
    Through the Clinical Trial Design and Management Certificate Program students may complete a full certificate or simply take those courses which advance their own professional goals. The program is designed to be flexible for working adults by offering evening or weekend courses. More »
  • Society of Clinical Research Associates
    SOCRA is a non-profit, charitable and educational membership organization committed to providing education, certification, and networking opportunities to all persons involved in clinical research activities. SOCRA, the premier educational organization for oncology site coordinators, has now emerged as a leading educational organization for clinical researchers in all therapeutic areas, supporting industry, government and academia. More »

HIPAA Training

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The Health Insurance Portability and Accountability Act (HIPAA) – Each person at the CTSI partner sites must be aware of the obligations imposed by HIPAA and the Privacy and Security Rules. See below for each site’s policy and training information.

UCLA

  • HIPAA Training (Required)
    The HIPAA Research training is a module of the Protecting Human Research Subjects online training site. The site, accessible here, requires registration and login.

Collaborative IRB Training Initiative (CITI)

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  • Questions?

Collaborative Institutional Training Initiative (CITI) training is required human subjects training for all staff working on a research project (all investigators and other study personnel, including all persons who are responsible for the design, conduct, data analysis or reporting of a research project).

UCLA

CITI Training (Required)
Required human subjects training for all key personnel who work on research projects (all investigators and other study personnel, including all persons who are responsible for the design, conduct, data analysis or reporting).

  • Register for Training
    This is the UCLA Office of the Human Research Protection Program (OHRPP) website. Site includes link to the CITI website to register for training, completion check list and FAQs.

Budgeting & Billing Training

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See the below resources to get more information on how to approach budgeting and billing on clinical research projects.

UCLA

Clinical Research and Clinical Trial activity at UCLA involves coordination of many areas and departments within the Medical Sciences enterprise and on the UCLA campus. The Office of Compliance Services created resources for the research community as it relates to conducting research in a responsible manner and in compliance with the applicable federal and state laws and regulations.

Research Administration Training

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  • Questions?
  • More information:

UCLA

The UCLA Office of Research Administration offers training classes and programs year round on various research administration topics. Register here.

Available courses include:

  • Introduction to Contract and Grant Administration
  • Proposal Preparation and Submission
  • Ledgers from a Research Perspective
  • Post Award Administration Handbook
  • Outgoing Subaward Initiation and Management
  • Effort Report Briefing for Investigators

Clinical Research Training

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  • Questions?
  • CTSI Training Program in Translational Science
    Provide clinicians and fellows with the necessary training to become successful patient-oriented investigators who can bridge molecular medicine and clinical research. The program has undergone extraordinary growth since its founding in 2000 to support the development and enhancement of core courses and in-depth training necessary for mastery of the fundamental skills, methodologies, theories, and conceptualizations of translational clinical investigation. More »
  • CTSI Responsible Conduct of Research Courses
    This course provides a thorough background in the ethical issues in research with emphasis on research involving humans. Discussion of current issues in responsible conduct of clinical research, including reporting of research, basis for authorship, issues in genetic research, principles and practice of research on humans, conflicts of interest, Institutional Review Board (IRB), and related topics. More »
  • Find a Workshop
    View upcoming educational workshops offered by CTSI and affiliates. More »
  • Workshop archive
    View past CTSI-supported workshops. More »

UCLA

Online clinical research training is available at UCLA Health Sciences Training Portal. Access the following courses:

  • Division of Laboratory Animal Medicine Training Website
  • Environment, Health and Safety Online Learning Center
  • Office of Research Administration Contract and Grant Administration Training
  • UCLA Online Training: Protection of Human Research Subjects Training Certificates & HIPAA Clinical Research Training Certificates

For a list of UCLA Research Resources, click here.

Electronic Health Record (EHR) Training

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  • Questions?

UCLA

CareConnect (Electronic Health Record) Training is required for UCLA Hospital and Clinics physicians and medical personnel who need access to hospital medical records and must be completed before beginning work. All users must demonstrate proficiency in using CareConnect to gain access to the system. Additionally, training is role-based and targeted to scope and specialty to ensure that it is relevant.

Staff/Managers – see registration process here.
Providers – see registration process here.

Clinical Contacts

Assistance with Grant Proposals

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CTSI Rapid Response Team provides grant proposal management software and assists investigators with brainstorming sessions. RRT also facilitates large team science proposals by supplying administrative support to collect supporting documents such as biosketches, letters of support and resources and facilities boilerplates.

Boilerplate Text for Grant Proposals

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Boilerplate text describing CTSI partner site institutions, programs, data repositories and more are available for use in your grant proposals.

Boilerplate text is available for the following categories:

  • CTSI and partner institutions
  • CTSI program areas
  • Clinical and Translational Research Centers
  • Research Cores
  • Regulatory
  • UCLA schools, departments, institutes and centers
  • UCLA hospitals and health system
  • Incubators, licensing and entrepreneurship
  • Research Data Repositories

Good Clinical Practice

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Good Clinical Practice (GCP) is an international ethical and scientific quality standard, published by the International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.

Good Clinical Practice guidelines include the protection of human rights, safety and welfare during clinical trials. They also assure clinical data integrity.

Good Clinical Practice guidelines include standards on how clinical trials should be conducted; and define the roles and responsibilities of clinical trial sponsors, clinical research investigators and monitors.

Useful Links

Education and Training

CTSI Courses

  • UCLA CTRC (Clinical and Translational Research Center) Research Networking Seminars
    The CTRC is offering monthly informal clinical research networking seminars to bring together faculty and staff, hear invited experts speak, discuss topics of current interest, and exchange best practices/solutions to common clinical research challenges. All members of the clinical research community are welcome and invited to attend. If you are interested in attending these monthly sessions (4th Thursday), please contact Dr. Laurie Shaker-Irwin lshakerirwin@mednet.ucla.edu to receive further information and to be placed on the e-mail list. View the CTSI Events calendar for details and topics.
  • Responsible Conduct of Research Courses
    This course provides a thorough background in the ethical issues in research with emphasis on research involving humans. Discussion of current issues in responsible conduct of clinical research, including reporting of research, basis for authorship, issues in genetic research, principles and practice of research on humans, conflicts of interest, Institutional Review Board (IRB), and related topics. More »

UCLA

  • Collaborative Institutional Training Initiative (CITI)
    Required human subjects training for all key personnel who work on research projects (all investigators and other study personnel, including all persons who are responsible for the design, conduct, data analysis or reporting). More »
  • GCP Training through Office of the Human Research Protection Program
    If you are new to research or just need a refresher course, Good Clinical Practice (GCP) offerings are available through OHRPP. More »

Other Resources

Related Videos

Grant Compliance & Institutional Oversight – Roles & Responsibilities

The roles and responsibilities of the UCLA CTSI partner sites’ organizational units, institutional officials and key individuals in the areas of grant compliance and institutional oversight are summarized below.

UCLA

  • Industry Relations
    Provides guidelines on industry activities for the David Geffen School of Medicine at UCLA and the UCLA Medical Enterprise. These guidelines help to raise awareness of the effects of medical marketing on patient care, and set standards for how our faculty, staff, and students should interact with the healthcare industry.
  • Office of Contract and Grant Administration (OCGA)
    Assists the campus research enterprise in the process of applying for, accepting, and administering contract and grant awards.
  • Office of the Human Research Protection Program (OHRPP)
    Ensures the safety and welfare of human research participants in studies conducted by UCLA faculty, staff or students. In addition, OHRPP supports the Institutional Review Board process and conducts post-approval monitoring and on-site reviews.
  • Office of Animal Research Oversight
    Oversees the animal care and use program at UCLA to ensure that activities involving animals are conducted in accordance with University policy and USDA animal welfare regulations. It reviews and approves proposals related to animal use, inspects animal facilities, and investigates reports of noncompliance, suspending animal use and taking corrective action as needed.
  • Office of Research Administration
    The primary role of the Office of Research Administration (ORA) is to provide the campus with professional guidance and administrative support for all sponsored research activities. Activities include:
    • Contract & grant administration (OCGA)
    • Research policy & compliance (RPC)
    • Extramural Fund Management (EFM)
    • Human Research Protection Program (OHRPP)
    • Animal Research Oversight (OARO)
  • Office of Intellectual Property Administration
    OIP-ISR supports UCLA faculty and student researchers pursuing collaborations with industry, protects UCLA intellectual property interests and advances discoveries toward commercial development.
  • Office of Clinical Trials
    Provides patients/community with a searchable database of clinical trials and patient education resources. Additionally, the site UCLA faculty/staff researchers can update information on trials and receive coverage analysis.

State and Local Resources

  • UC Office of Research and Graduate Studies
    The Office of Research and Graduate Studies (ORGS) is a resource for UC researchers and administrators in research policy, funding for system-wide programs, technology transfer, and graduate education. They work to build UC-wide partnerships, help shape effective policies and provide a strong voice nationally for research and graduate education on behalf of UC.
  • UC Office of Technology Transfer
    The Office of Research and Graduate Studies and the campus technology transfer offices manage the use of University research results for the public benefit. We provide patenting, licensing, and other commercialization support to faculty and researchers at our ten campuses and Lawrence Berkeley National Laboratory.
  • UC Discovery Grants
    The Industry-University Cooperative Research Program (IUCRP) awards MICRO Grants and UC Discovery Grants in targeted fields of science and engineering. UC Discovery Grants form a 3-way partnership between UC, Industry Sponsors, and the State of California.

Roles & Responsibilities – Administrative Process Initiation

next steps

PI and/or Study Coordinator

  • Prepares IRB submission
  • Negotiates consent form with sponsor
  • IRB notifies PI/coordinator of submission

PI resolves conflicts of interest if necessary, responds to IRB

Clinical and Translational Research Centers

UCLA

The below are applicable if a study is being performed in the UCLA CTRC

  • Obtains copies of IRB application and approved consents from the PI.
  • Reviews study protocol and informed consent to be sure study qualifies for rates for non-profits/industry sponsored research.

Roles & Responsibilities – Pre-Study Start-up

next steps

  • Submit a CTRC application
  • Submit your application for review to the Clinical and Translational Research Centers

PI and/or Study Coordinator:

  • Supplies contact information and draft contract to clinical trials office.
  • Coordinates submission of FDA forms
  • Signs confidentiality agreements (PI)
  • Participates in Investigator/start-up meeting
  • Receives protocol from sponsor
  • Assesses study feasibility – staff, facilities, etc.
  • For PI-initiated studies, consults with clinical trials office to create a budget proposal to submit to an industry sponsor
  • For PI-initiated studies, works through UCLA CTSI to obtain services as needed
  • If required by the sponsor, obtain institutional representative

Contracts

UCLA

  • Non-profit study: Office of Contracts and Grants Administration communicates with PI or study coordinator as needed regarding contract terms and conditions.
  • Industry-sponsored research study: Clinical Trials Administration Office communicates with PI or study coordinator as needed regarding contract terms and conditions.

Clinical and Translational Research Centers

UCLA-Westwood

  • As needed, the UCLA-Westwood CTRC consults with PI and/or study coordinators on clinical procedures, pricing, regulatory issues, hospital requirements, and clinical and/or operational aspects of the study.
  • As needed, the UCLA-Westwood CTRC offers training and advice on study start-up, IRB preparation, hospital contacts, sponsor interactions.
  • For PI-initiated studies, the UCLA-Westwood CTRC provides the following consultations:
    • Biostatistical consults
    • Biomedical informatics consults
    • Ethics consults

Roles & Responsibilities – Budgeting

next steps

PI and/or Study Coordinator

  • Determines study eligibility for Medicare NCD.
  • Identifies patient care costs in the study that are routine care versus research costs to be paid by the sponsor.
  • Determines the level of effort required for study personnel to execute a study.
  • Identifies the locations where the research related items will be performed.
  • If study qualifies under NCD, works with clinical trials office to determine if any research costs can be billed to insurance.
  • Consults with hospital ancillary services experts to correctly analyze feasibility, identify protocol required procedures and to schedule study subjects with hospital specialty areas.
  • May need to provide patient information for unusual or complex procedures in order to obtain billing reports.
  • For device studies, prepares Medicare FI preauthorization packet for submission.
  • Acquires prices from available databases or Hospital Departments.

Clinical and Translational Research Centers

UCLA-Westwood

  • Review approved protocol, IRB application, consent
  • Assist with acquiring pricing from available databases or Hospital Departments
  • Establishes discounts for research prices.
  • Provides pricing information as needed.

OTHER RESOURCES

UCLA

Mentoring Support for Junior Investigators

For mentoring and career development opportunities at UCLA CTSI partner sites, please see below.