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CREC Research Seminar Upcoming Events Calendar

 
 



Upcoming Seminars

Date/Time of Event

Title/Description

Credits

Location

Spring 2015

5/22/2015
10:00
- 11:00 AM
CANCELLED: Investigator and Study Team Responsibilities
Do you understand the responsibilities of an investigator when conducting clinical research? It is essential all members of the clinical research team, including the Principal Investigator, understand these responsibilities and also the appropriate delegation of these responsibilities to study staff. Plan to attend this informative session and learn from colleagues with numerous years of experience in conducting and managing clinical research. All Principal Investigators are encouraged to attend this session.

This session will be led by Steven Strausbaugh, MD, Assistant Professor of Pediatrics, Division of Pulmonology and Carol Fedor, ND, RN, CCRC, Director, Human Research Protection Program
3 UH RB&C Amphitheater Register
5/26/2015
8:00
- 9:00 AM
Data Management Series-Advanced 4: Study Infrastructure Template
A template to help organize the entire study.

Presented by Carolyn Apperson-Hansen is the Director of the Research Concierge Service
0 Lakeside 1400, UHCMC Register

Summer 2015

6/2/2015
8:00
- 10:00 AM
Investigator Training: Good Clinical Practices (GCP) and Principal Investigator (PI) Responsibilities
This session will include discussions of the relationships between laws, regulations, guidelines, and standard operating procedures. Key obligations of sponsors, monitors and investigators and their inter-relationships will be described.

Objectives:
  • To understand the relationship between laws, regulations and guidelines
  • To learn the obligations of sponsors, monitors and investigators


  • Presented by: George H. Addamio, PhD, President of PharmConsult, Inc., a consulting firm in Atlanta, GA that specializes in the preparation of clinical development documents.
    0 WRB 1413 Register
    6/2/2015
    10:15
    - 11:30 AM
    Investigator Training: Ethical Considerations, Informed Consent and Financial Disclosure
    This session will include a brief historical perspective of ethical considerations in conducting clinical research. The elements and process for obtaining informed consent from potential study participants will be discussed and well as financial disclosure.

    Objectives: Informed Consent
  • To understand the elements of informed consent and recognize consent as an ongoing process
  • To discuss challenges associated with obtaining informed consent
  • To understand the rationale for financial disclosure and learn reporting requirements
  • To know studies to which financial disclosure rules apply


  • Presented by: George H. Addamio, PhD, President of PharmConsult, Inc., a consulting firm in Atlanta, GA that specializes in the preparation of clinical development documents.
    0 WRB 1413 Register
    6/3/2015
    12:00
    - 1:30 PM
    An Introduction to UH REDCap (Research Electronic Data Capture) Software
    Come learn about UH! REDCap (Research Electronic Data Capture). This database software is a secure web application for building and managing online surveys and databases and provides audit trails for tracking data manipulation and user activity, as well as automated export procedures for seamless data downloads to Excel, PDF, and common statistical packages (SPSS, SAS, Stata).

    UH REDCap will allow the safe, secure storage of all your research data, including the storage of PHI (Protected Health Information) HIPAA identifier fields for your UH IRB protocols.

    Presented by Sheree Hemphill, MS DCRU Informatics Manager, CTSC Biomedical Informatics Core
    0 Kulas Auditorium, UHCMC Register
    6/4/2015
    8:00
    - 9:00 AM
    Pre-Clinical data: How much is enough to submit a drug or device protocol to the FDA?
    This session will provide helpful insight into the level of detail that the FDA will need to see when reviewing drug or device applications for clinical trial approval. What type of testing will the FDA look to be completed prior to the submission of an IND or IDE, what product testing will need to have been completed, and the differences between GLP and GMP testing requirements by the FDA.
    Presented by Jenna Stump, MS,CCRP and Joseph Rutter, BS
    0 Kulas Auditorium, UHCMC Register
    6/8/2015
    12:00
    - 1:00 PM
    Submitting a Continuing Review Application and Closure Form to the UH IRB
    Do you have questions about what is required to be submitted to the IRB for your continuing review (CR ) or closure?

    This program will include an in-depth review of the elements required for both continuing review and study closure submissions. Tips for preventing a lapse in IRB approval will be discussed.

    Presented by Elizabeth Hagesfeld, MA Human Subjects Protection Specialist II , Center for Clinical Research and Technology
    3 Kulas Auditorium, UHCMC Register
    6/11/2015
    9:00
    - 10:00 AM
    New Protocol Submissions-Getting Started with the IRB and iRIS
    Are you preparing to submit to the UH IRB? This session provides the information to get started. We will review the IRB submission process and policy that covers all required elements and demonstrate how to complete one using iRIS.



    Presented by April Smith, BA, IRB Specialist II
    3 UH RB&C Amphitheater Register
    6/11/2015
    3:00
    - 4:00 PM
    How to use Research Match as a Recruitment Tool
    Research Match has a simple goal - to bring together two groups of people who are looking for one another:

    1. People trying to find research studies to participate in

    2. Researchers who are looking for study participants

    During this session researchers will learn step by step how to register and begin utilizing this valuable tool to increase enrollment in their studies.

    Attend from your desk and register using this link: https://student.gototraining.com/r/6850108431737965824

    Presented by ResearchMatch Program Manager,Kathy Edson, Vanderbilt University
    0 WebEx Register
    6/15/2015
    12:00
    - 1:00 PM
    Event Reporting: Understanding Adverse Events, Unanticipated Problems and Protocol Deviations
    This session will define and discuss reporting requirements of adverse events, protocol deviations and unanticipated problems per the UH Institutional Review Board's (IRB) policies.

    Case studies will be used to illustrate the reporting requirements and tools to assist in capturing this information will be reviewed. Proper reporting of events to the IRB is critical to protecting the safety and welfare of research participants.

    Presented by Loretta Williams, MPH, Compliance and Education Specialist
    3 UH RB&C Amphitheater Register
    6/18/2015
    10:00
    - 11:00 AM
    RESHEDULED to 6/8/2015: Submitting a Continuing Review Application to the UH IRB using iRIS
    Do you have questions about what is required to be submitted to the IRB for your continuing review (CR)?

    This program will include an in-depth review of the elements required for continuing review submissions that are reviewed either by the full IRB or administratively. Tips for preventing a lapse in IRB approval will also be discussed.
    Presented by Karya Ottey, MA, CIP IRB Specialist II
    3 Kulas Auditorium, UHCMC Register
    6/25/2015
    8:00
    - 9:00 AM
    Part 11 Compliance and your FDA Protocols: Taking into account the FDA Regulations and Applying to your Research Applications
    Presented by Jenna Stump, MS, CCRP, and Joseph Rutter, BS
    0 UH RB&C Amphitheater Register
    7/9/2015
    8:00
    - 9:00 AM
    Protocol Writing: Piecing together a Drug Application
    For those investigators and research personnel planning to conduct an investigational new drug application with the FDA; this session will provide details on the nuances of protocol writing for the FDA, helpful tips on what FDA reviewers will need to see in order to grant approval, essential elements relating to risk analysis/safety for protocol inclusion, an ways to ensure scientific soundness when piecing together your protocol.

    Presented by Jenna Stump, MS, CCRP and Joseph Rutter, BS
    0 UH RB&C Amphitheater Register
    7/9/2015
    3:00
    - 4:00 PM
    How to Use ResearchMatch as a Recruitment Tool
    Research Match has a simple goal - to bring together two groups of people who are looking for one another:

    1. People trying to find research studies to participate in

    2. Researchers who are looking for study participants

    During this session researchers will learn step by step how to register and begin utilizing this valuable tool to increase enrollment in their studies.

    Attend from your desk and register using this link: https://student.gototraining.com/r/6850108431737965824

    Presented by Catherine Gregor, MBA, CCRP, CCRC Project Manager, ResearchMatch
    0 WebEx Register
    7/16/2015
    9:00
    - 10:00 AM
    Improving the Infromed Consent and Eligibility Confirmation Process
    This session covers a general overview of the Informed Consent Process and frequently asked questions. Please bring your own questions and examples from studies you are involved with to help us understand and develop our skills. Particular emphasis will be placed on confirming eligibility prior to performing any study procedures.

    Presented by Carrie O'Neill, BS, CCRP
    3 Kulas Auditorium, UHCMC Register
    7/23/2015
    8:30
    - 5:00 PM
    Clinical Research Orientation
    The Center for Clinical Research and Technology offers the Clinical Research Orientation program which is required for staff new to conducting clinical research at University Hospitals.

    The UH Clinical Research Orientation will provide individuals involved in conducting clinical research, valuable information about navigating the research system at UH, as well as reference materials that address working with the IRB, institutional policies and contacts, research financials, regulations that govern clinical research, and the primary duties of those conducting clinical research.

    To register for the Clinical Research Orientation or for more information, please contact Carrie O'Neill in the Office of Research Compliance and Education at Carrie.O'Neill@UHhospitals.org or 216-286-2283 or register through LMS.
    6 Bolwell A Conference Room Register
    7/24/2015
    8:00
    - 9:00 AM
    Dietary Supplements and Vitamins: Is an IND required?
    This session provide information on the FDA’s regulatory oversight of dietary supplements and Vitamins, discuss in detail the reasons that would require an FDA review of a supplement or vitamin protocol, and the most effective regulatory pathway with the FDA should their review be required.

    Presented by Jenna Stump, MS, CCRP and Joseph Rutter, BS
    0 UH RB&C Amphitheater Register
    7/27/2015
    9:00
    - 10:00 AM
    Research Documentation-The Nuts and Bolts
    This session provides an overview of the fundamentals of research documentation, including, source documents, CRFs, essential regulatory documents required under ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) and FDA regulations, storage and retention requirements for research data and tips for organizing and maintaining your research records.

    Presented by Carmen Czich, RN, BSN, CCRP
    3 UH RB&C Amphitheater Register
    8/7/2015
    9:00
    - 10:00 AM
    Regulatory Binder and Essential Documents
    Are you responsible for maintaining all the required regulatory documents for your research study? Are you unclear what documents you need to maintain in your regulatory binder?

    Presented by Carrie O'Neill, BS, CCRC, Compliance and Education Specialist, CCRT, UHCMC During this session, the UH Office of Research Compliance and Education will walk through an example of essential regulatory documents and what your regulatory binder should contain. Bring your "reg binder" to the session and we can help you identify missing information or help you get started in creating one.
    Presented by Carrie O'Neill, BS, CCRC, Compliance and Education Specialist, CCRT, UHCMC
    3 UH RB&C Amphitheater Register
    8/12/2015
    10:00
    - 11:00 AM
    Chart Reviews and Discarded Tissue Studies
    This course covers the specific requirements for submission of this unique category of research.

    Presented by Beth Hagesfeld, MA, CCRP, IRB Specialist II
    3 UH RB&C Amphitheater Register
    8/13/2015
    3:00
    - 4:00 PM
    How to Use ResearchMatch as a Recruitment Tool
    Research Match has a simple goal - to bring together two groups of people who are looking for one another:

    1. People trying to find research studies to participate in

    2. Researchers who are looking for study participants

    During this session researchers will learn step by step how to register and begin utilizing this valuable tool to increase enrollment in their studies.

    Attend from your desk and register using this link: https://student.gototraining.com/r/6850108431737965824

    Presented by Catherine Gregor, MBA, CCRP, CCRC Project Manager, ResearchMatch, Vanderbilt University
    0 WebEx Register
    8/20/2015
    8:00
    - 9:00 AM
    Protocol Writing: Piecing Together a Device Application
    For those investigators and research personnel planning to conduct an investigational device exemption application with the FDA; this session will provide details on the nuances of protocol writing for the FDA, helpful tips on what FDA reviewers will need to see in order to grant approval, essential elements relating to risk analysis/safety for protocol inclusion, correct way to compile a device description packet, and ways to ensure scientific soundness when piecing together your protocol.

    Presented by Jenna Stump, MS, CCRP and Joseph Rutter, BS.
    0 UH RB&C Amphitheater Register
    8/21/2015
    10:00
    - 11:00 AM
    Investigator and Study Team Responsibilities
    Do you understand the responsibilities of an investigator when conducting clinical research? It is essential all members of the clinical research team, including the Principal Investigator, understand these responsibilities and also the appropriate delegation of these responsibilities to study staff. Plan to attend this informative session and learn from colleagues with numerous years of experience in conducting and managing clinical research. All Principal Investigators are encouraged to attend this session.

    This session will be led by Steven Strausbaugh, MD, Assistant Professor of Pediatrics, Division of Pulmonology and Carol Fedor, ND, RN, CCRC, Director, Human Research Protection Program
    3 UH RB&C Amphitheater Register
    8/24/2015
    12:00
    - 1:00 PM
    Human Subjects Research and Exempt Determination
    Federal regulations allow certain research activities involving human subjects to be exempt from IRB full or expedited review. This session discusses:
    • Types of IRB Review
    • IRB Determination of Exempt Review
    • Case Studies


    • Presented by Joseph Gibbons, MD, UHCMC IRB Chair; Assistant Professor of Medicine, Division of Hematology/Oncology
    3 UH RB&C Amphitheater Register
    8/28/2015
    9:00
    - 10:00 AM
    Top Common Non-Compliance Findings
    The UHCMC Office of Research Compliance and Education will review the top non-compliance findings identified through monitoring of clinical research. Helpful tips and tools will be provided to help research teams prevent these significant findings.

    Presented by Loretta Williams, MPH, CCRP Compliance and Education Specialist
    3 UH RB&C Amphitheater Register

    Fall 2015

    9/10/2015
    8:00
    - 9:00 AM
    Residents and Fellows Training: Getting Approved-IRB Survival Guide
    This session is ideal for residents, fellows, students, new researchers, and their advisors. Research Coordinators and Regulatory Specialists can also benefit from attending!

    Tips for obtaining IRB approval will be reviewed at this session. A step by step guide to starting out. Some questions we will answer: How long does it take? What is the overall process? iRIS tips and tricks. Presented by Lydia Furman, MD, Chairperson, Department of Pediatrics Clinical Research Review Committee, Vice-Chairperson Institutional Review Board, University Hospitals Case Medical Center
    3 UH RB&C Amphitheater Register
    9/10/2015
    3:00
    - 4:00 PM
    How to Use ResearchMatch as a Recruitment Tool
    Research Match has a simple goal - to bring together two groups of people who are looking for one another:

    1. People trying to find research studies to participate in

    2. Researchers who are looking for study participants

    During this session researchers will learn step by step how to register and begin utilizing this valuable tool to increase enrollment in their studies.

    Attend from your desk and register using this link: https://student.gototraining.com/r/6850108431737965824

    Presented by Catherine Gregor, MBA, CCRP, CCRC Project Manager, ResearchMatch, Vanderbilt University
    0 WebEx Register
    9/23/2015
    12:00
    - 1:30 PM
    An Introduction to UH REDCap (Research Electronic Data Capture) Software
    Come learn about UH! REDCap (Research Electronic Data Capture). This database software is a secure web application for building and managing online surveys and databases and provides audit trails for tracking data manipulation and user activity, as well as automated export procedures for seamless data downloads to Excel, PDF, and common statistical packages (SPSS, SAS, Stata).

    UH REDCap will allow the safe, secure storage of all your research data, including the storage of PHI (Protected Health Information) HIPAA identifier fields for your UH IRB protocols.

    Presented by Sheree Hemphill, MS DCRU Informatics Manager, CTSC Biomedical Informatics Core
    0 UH RB&C Amphitheater Register
    9/24/2015
    9:00
    - 10:00 AM
    Submitting a Continuing Review Application and Closure Form to the UH IRB using iRIS
    Do you have questions about what is required to be submitted to the IRB for your continuing review (CR ) or closure?

    This program will include an in-depth review of the elements required for both continuing review and study closure submissions. Tips for preventing a lapse in IRB approval will be discussed.

    Presented by April Smith, BS, CCRP, IRB Specialist II, Center for Clinical Research and Technology
    3 UH RB&C Amphitheater Register
    9/28/2015
    12:00
    - 1:00 PM
    Understanding Emergency Use of Investigational Drugs, Biologics or Devices
    During this session, participants will learn about the Emergency Use of Investigational Drugs, Biologics, or Devices. The discussion will include investigator responsibilities, IRB responsibilities and the criteria allowing for the emergency use of a test article.

    This session will be lead by Joseph Gibbons, MD, UHCMC IRB Chair; Assistant Professor of Medicine, Division of Hematology/Oncology. Time will be available at the end of the session to ask your questions.
    3 UH RB&C Amphitheater Register
    9/30/2015
    12:00
    - 1:00 PM
    Event Reporting: Understanding Adverse Events, Unanticipated Problems and Protocol Deviations
    This session will define and discuss reporting requirements of adverse events, protocol deviations and unanticipated problems per the UH Institutional Review Board's (IRB) policies.

    Case studies will be used to illustrate the reporting requirements and tools to assist in capturing this information will be reviewed. Proper reporting of events to the IRB is critical to protecting the safety and welfare of research participants.

    Presented by Loretta Williams, MPH,CCRP,Compliance and Education Specialist II
    3 UH RB&C Amphitheater Register