We do not support your browser. Please take a moment and upgrade to the most recent version of Internet Explorer.
About

Participant and Clinical Interactions

next

  • Nadia Aibani, M.P.H.

    Nadia Aibani, M.P.H.

    Charles R. Drew University


    Recruitment Specialist


  • Raquel Gutierrez

    Raquel Gutierrez

    LA BioMed

    Administrative Lead


  • Cynthia Gonzalez, M.P.H.

    Cynthia Gonzalez, M.P.H.

    Charles R. Drew University



    Research Associate/Bilingual


  • Patricia Jardack, M.S., R.D.N.

    Patricia Jardack, M.S., R.D.N.

    UCLA


    Dietician


  • Holly Johnson

    Holly Johnson

    Charles R. Drew University

    Administrative Lead


  • Martin Lai, M.S.

    Martin Lai, M.S.
    UCLA

    Programmer Analyst


  • Mindy Mamelak, R.D.

    Mindy Mamelak, R.D. 

    Cedars-Sinai

    Bionutritionist


  • Stephanie Okimoto

    Stephanie Okimoto

    UCLA

    Research Study Coordinator


  • Debby Peterson

    Debby Peterson

    Cedars-Sinai

    Administrative Lead


  • Laurie Shaker-Irwin, Ph.D., M.S.

    Laurie Shaker-Irwin, Ph.D., M.S.

    UCLA


    Research Study Administrator


  • Helen Williams-Bayne, M.B.A.

    Helen Williams-Bayne, M.B.A.

    UCLA


    Administrative Director


  • Chen (Anna) Zheng

    Chen (Anna) Zheng

    UCLA

    Administrative Specialist

next

Program Description

The Participant and Clinical Interactions Program (PCI) plays a critical role in assuring that clinical research at the UCLA CTSI partners is performed safely, efficiently and reliably. It provides scientific review before study initiation and data and safety oversight throughout the study process to ensure that research is performed to the highest standards of scientific rigor and subject safety.

Program Aim

The aim of the Participant and Clinical Interactions (PCI) Program is to ensure that human subjects research performed within the CTSI is safe, efficient, reliable and of the highest quality. To accomplish this aim, the PCI Program has established five objectives.
  • Objective 1. Ensure quality, feasibility and safety in human subjects research.
  • Objective 2. Certify competency and credentialing for research teams.
  • Objective 3. Safeguard the efficient conduct of clinical research.
  • Objective 4. Maintain an equitable service voucher system.
  • Objective 5. Guarantee full compliance with clinaltrials.gov.

Program Services

  • Scientific Review Committee (SRC). Each of the partner institutions will have a local SRC, which meets every two weeks or as needed to assure timely reviews with written feedback to the investigator.
  • Faculty Advice and Consultation Service (FAC) is a short-term mentorship program for junior investigators to facilitate and accelerate the approval, conduct, and completion of their protocols. Junior investigators selected for FAC mentorship support will meet every two weeks (4-6 total sessions) with a senior research professional who has at least a decade of clinical research experience as a PI or Co-PI. A pool of senior faculty, all with active clinical research programs, will participate in FAC and a roster of FAC faculty, will be given to junior faculty so they can select a mentor with appropriate background.
  • The Clinical Trial Operations Team (CTOT) focuses on key elements required for rapid clinical trials start-up and completion: (1) study initiation, including institutionally-supported clinical research space allocation; (2) subject management; and (3) on-study support. Those elements are outlined below.

    Study initiation facilitation includes:
    • Ensuring complete data is in the Clinical Trials Management System so the study can be opened in the health system via the electronic medical record system
    • Ensuring the trial is registered at clinicaltrials.gov
    • Organizing and attending a site initiation meeting
    • Ensuring the proper delegation of authority for the study

    Subject management facilitation includes:

    • Subject consenting and HIPAA research authorization
    • Drug dispensing and monitoring
    • Subject and clinical service payment
    • Adverse event and deviation tracking
    • Submission of serious adverse events and responding to safety reports
    • Completion of Case Report Forms (CRFs)
    • Calendaring and scheduling visits
    • Sponsor invoicing based on subject milestones.

    Clinical research onstudy support. For investigators without their own research staff capable of carrying out all study procedures, the CTRCs offer access to institutionally-supported clinical research space and employable (on a cost-recovery basis) skilled hands-on research personnel; this funding model is attractive to investigators given its scalability and opportunities for cross coverage of multiple studies. Each partner CTRC is headed by experienced research professionals who supervise all the research nursing staff, perform safety/feasibility reviews of all studies using CTRC resources, maintain SOPs and assure CTRC staff certification. Research nurses (RNs and in some cases LVNs) are used to support Phase I-III studies, infusions and most clinical nursing procedures required in clinical research. In addition to the research nursing staff and depending on local needs, the teams may include other research personnel, such as a dietician, a phlebotomist and an ultrasound technician. The CTSI sites offer specially designed venues for safe performance of high quality clinical research protocols.
  • E-Voucher Program. A competitive e-voucher request and funding system is currently under ß-testing in the PCI.

    It will favor junior scientists with investigator-initiated protocols and extramural, career development support. The 600 word applications will be reviewed on a rolling basis by a minimum of three reviewers from the SRC/FAC, using a 10-point scoring system.
  • Guarantee full compliance with clinicaltrials.gov
    • Study Registration. PCI will work with investigators at all CTSI sites to ensure compliance with the registration requirement.
    • Study Results Reporting. PCI will help investigators meet their clinical trials results reporting requirement. PCI will work with the investigative team to facilitate the creation of the (1) participant flow table, basic characteristics table, (3) outcome measure and statistical analyses table and (4) adverse event tables. This unit will facilitate uploading of data in the Protocol Registration and Results sections of www.clinicaltrials.gov.

Cedars-Sinai Medical Center
Debby Peterson
310-423-8969

Charles R. Drew University of Medicine and Science
Holly Johnson
323-568-3355

Los Angeles Biomedical Institute at Harbor-UCLA Medical Center
Raquel Gutierrez
310-222-2503

UCLA-Westwood
Helen Williams-Bayne
310-267-1029