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).

Spring 2017

4/28/2017 
11:30 
- 1:00 PM
Submitting a Pre-IDE Application to the FDA
This session is applicable for any investigator or research personnel who are unsure if the device they are working with or developing is classified as significant rick or non-significant risk. Learn the basics of submitting a Pre-IDE Application to the FDA, the differences between a significant risk vs. non significant risk device, and the nuances of device applications and submissions to the FDA. 

Presented by Jenna Stump, MS,CCRP, Manager, Center for Clinical Research and Technology
0 UH Lakeside, Room 1400 Register
5/2/2017 
9:30 
- 10:30 AM
Data Management Series, Advanced 1- The Regulations: HIPAA for Research
Ensure data collection and management complies with HIPAA privacy laws. Review PHI and identifiers. Common Rule vs. Privacy Rule. 

Presented by Carolyn Apperson-Hansen, Director, Research Concierge
3 CWRU SOM WG-86 Register
5/4/2017 
11:30 
- 1:00 PM
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 Lakeside, Room 1400 Register
5/9/2017 
9:30 
- 10:30 AM
Data Management Series, Advanced 2- The Regulations: 21 CFR Part 11
Scope and application guidance, electronic records, electronic signatures, and validation. 

Presented by Carolyn Apperson-Hansen, Director, Research Concierge
3 CWRU SOM WG-86 Register
5/12/2017 
11:30 
- 1:00 PM
How do you know when an Investigational New Drug (IND) application is required?
All investigators are invited to bring their staff to discuss the UHCMC process for obtaining an investigator held Investigational New Drug (IND) Application and will include: 

  • How an investigator can determine if an IND approval from the FDA is needed.
  • Elements included in an IND application.
  • Understanding FDA submission guidelines.
  • How the approval process works. UH policies related to the use of Investigational drugs.

  • Presented by Jenna Stump, MS, CCRP, Manager, Center for Clinical Research and Technology
    0 UH Lakeside, Room 1400 Register
    5/16/2017 
    11:30 
    - 12:30 PM
    Data Management Series, Advanced 3- Data Safety Monitoring Board
    A system for the oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data. The data and safety monitoring functions and oversight of study activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). 

    Presented by Carolyn Apperson-Hansen, Director, Research Concierge
    3 CWRU SOM WG-86 Register
    5/18/2017 
    11:30 
    - 1:00 PM
    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
    5/23/2017 
    9:30 
    - 10:30 AM
    Data Management Seris, Advanced 4- Study Infrastructure Template
    A template to help organize the entire study. 

    Presented by Carolyn Apperson-Hansen, Director, Research Concierge
    3 CWRU SOM WG-86 Register
    5/26/2017 
    11:30 
    - 1:00 PM
    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

    Summer 2017

    6/1/2017 
    11:30 
    - 1:00 PM
    IRB: Continuing Review Application or Study Closure
    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 IRB Staff
    3 UH Lakeside, Room 1400 Register
    6/6/2017 
    9:00 
    - 10:30 AM
    Informed Consent Workshop
    Join us during this interactive workshop covering the following: 

  • First Hour- Writing the document
  • Second Hour-Consent a Subject. Please bring a copy of an IRB approved consent form from a study you are working on to the session

  • Presented by April Smith, CCRP, IRB Specialist and Janet Peachey, IRB Specialist
    0 UH Lakeside, Room 1400 Register
    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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