Identify Funding Opportunities Proposal Development Award Management Compliance Review and Oversight Education and Training Technology Transfer
Office of Research and Technology Management
Identify Funding Proposals Proposal Development Award Management Compliance Review and Oversight Education and Training Technology Transfer

CREC Research Seminar Upcoming Events Calendar

 
 



Upcoming Seminars

Date/Time of Event

Title/Description

Credits

Location

Fall 2017

10/24/2017
9:00
- 10:30 AM
RESCHEDULED: Study Visit Workshop 1: Study Start- Up
During this interactive session, participants will learn what steps to take for a research study start-up. We will discuss study feasibility, take an in-depth look at a research protocol and steps for developing an informed consent form (ICF) and source document.

Presented by Carrie O'Neill and Alycia Slaton
2 UH Lakeside, Room 1400 Register
10/27/2017
11:30
- 1:00 PM
IRB: 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 the UH IRB Staff
    0 UH Lakeside, Room 1400 Register
    11/2/2017
    11:30
    - 1:00 PM
    The Basics- An Education Series for Researchers, MODULE 1, FDA Regulations
    By the end of this module, you will learn and apply the following:

  • Know the history of the Federal Regulations and ICH GCP
  • How to identify the Code of Federal Regulations
  • Understanding of the general content of the Code of Federal Regulations and ICH GCP Guidelines
  • Understand the requirements of the Federal Regulations, Good Clinical Practice as it relates to FDA audits


  • Presented by Alison Campbell, Clinical Research Quality Assurance Specialist, UHC Clinical Trials Unit
    3 UH Lakeside, Room 1400 Register
    11/7/2017
    9:00
    - 10:30 AM
    RESCHEDULED: Study Visit Workshop 2: Mock Study
    During this interactive session, participants will take an in-depth look at an example research protocol and participate in a mock patient visit for a practical look at what happens before, during and after a clinical research study visit. Participants will learn how to use a protocol, how to fill out source documents and how to identify and report adverse events.

    presented by Carrie O'Neill, Alycia Slaton and Carmen Czich
    2 UH Lakeside, Room 1400 Register
    11/9/2017
    11:30
    - 1:00 PM
    Informed Consent Workshop
    Join us during this interactive workshop covering the following:

  • Waiver of Consent and Special Circumstances
  • Short Forms
  • Assents
  • Information Sheets
  • Waiver of Written Consent
  • Written Consent

  • Presented by UH IRB Staff
    3 UH Lakeside, Room 1400 Register
    11/9/2017
    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://attendee.gototraining.com/r/9112903382698216193

    Presented by Loretta Byrne, RN, MS, CCRP, Research Services Consultant II, Vanderbilt University
    0 WebEx Register
    11/14/2017
    9:00
    - 10:30 AM
    RESCHEDULED: Study Visit Workshop 3: Maintenance, Monitoring, and Closeout
    During this interactive session, participants will discuss how to handle protocol changes, research staff training, data management and query resolution. We will also take a look at preparing a study for closure including final study report, data cleaning, and publication.

    Presented by Carrie O'Neill and Alycia Slaton
    2 UH Lakeside, Room 1400 Register
    11/16/2017
    9:00
    - 10:30 AM
    The Basics- An Education Series for Researchers: Module 2, Regulatory Binder and Essential Documents
    During this session, we will define essential regulatory documents and discuss 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 putting one together.

    Presented by Carrie O'Neill, CCRC, Manager, Research Education, Compliance and Community Outreach
    3 UH Lakeside, Room 1400 Register
    12/6/2017
    11:30
    - 1:00 PM
    The Basics- An Education Series for Researchers: MODULE 3- Study Activation
    This module will define protocol development and activation, its guiding principles, the document, and overall process for obtaining at University Hospitals.

    Presented by Carrie O'Neill
    0 UH Lakeside, Room 1400 Register
    12/7/2017
    10:00
    - 11:30 AM
    Pathway for Approval - Regulatory Pathway for Devices through the FDA and IRB
    If you’re an investigator who is walking the pathway for approval for an investigational device with the FDA and IRB, this session will help navigate the requirements for both!

    Learn what the FDA will look for when reviewing your device, what items are transferable from the FDA application to the IRB, and long term maintenance steps to ensure compliance with the FDA and IRB.

    Presented by UH FDA/Regulatory Support and IRB Staff
    0 UH Lakeside, Room 1400 Register
    12/8/2017
    9:30
    - 11:00 AM
    IRB: Preparing a Successful Submission
    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 the UH IRB Staff
    3 UH Lakeside, Room 1400 Register
    12/14/2017
    8:30
    - 4:30 PM
    UH 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 Collin Tubic in the Office of Research Compliance and Education at Collin.Tubic@uhhospitals.org or 216-844-7018 or register through LMS.
    6 UH Bolwell Conference Room A Register
    12/28/2017
    9:00
    - 10:30 AM
    RESCHEDULED: IRB: Amendments, & Revisions
    This session walks through the process of amending an approved study and revising and attaching documents in Iris.

    Presented by UH IRB Staff
    0 UH Lakeside, Room 1400 Register