Research Seminars and Workshops

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The seminars listed below are designed to educate investigators and graduate students on grant and contract process, as well as the regulatory requirements they must follow. The seminars are taught by experienced, industry-leading professionals; many seminars are approved for research education credits (CREC).

Summer 2017

6/9/2017 
11:30 
- 1:00 PM
FDA Guidance Core Lecture Series: Application Essentials: Pre-IND and Full IND Application
Investigators are invited to bring their staff to discuss what essentials are needed for a Pre-IND and the Full IND application. Some of the essential items discussed for an Investigational New Drug (IND) Application and will include the following: 
  • Pre-IND advice may be requested for issues related to data needed to support the rationale for testing a drug in humans; the design of nonclinical pharmacology, toxicology, and drug activity studies, including design and potential uses of any proposed treatment studies in animal models; data requirements for an Investigational New Drug (IND) application; initial drug development plans, and regulatory requirements for demonstrating safety and efficacy.
  • How to fully utilize FDA Guidance Documents to structure and complete your complete IND Application; what is required, where to send it, and who to contact; what research challenges to avoid to complete a Full IND Application; and why research support is essential.

  • Presented by Jenna Stump, MS, CCRP, Manager, Center for Clinical Research
3 UH Lakeside, Room 1400 Register
6/15/2017 
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
    0 UH Lakeside, Room 1400 Register
    6/20/2017 
    9:00 
    - 10:30 AM
    The Basics- An Education Series for Researchers: Module 1, 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, Research Compliance and Education Specialist
    3 UH Lakeside, Room 1400 Register
    6/22/2017 
    8:30 
    - 4:30 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' This e-mail address is being protected from spambots. You need JavaScript enabled to view it or 216-286-2283 or register through LMS.
    6 UH Bolwell Conference Room A Register
    6/27/2017 
    9:00 
    - 10:30 AM
    The Basics- An Education Series for Researchers: MODULE 9- 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 Mary Bilancini,& Carmen Czich
    0 UH Lakeside, Room 1400 Register

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