Research Seminars and Workshops

medicine_research

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

2/3/2017 
11:00 
- 1:00 PM




2/16/2017 
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
2/17/2017 
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
2/21/2017 
9:00 
- 10:30 AM
The Basics- An Education Series for Researchers: Module 6, Coverage Analysis & Research Billing Compliance
Attendees will receive an overview of the entire billing process from patient registration through claim resolution and will learn about the positive impact coverage analysis has on study budgets and in streamlining the charge reconciliation process. Topics will include: research patient scheduling; required UH Center for Clinical Research & Technology notification; utilization of the shared drive for patient study lists and coverage analysis; and billing through Oncore. 

Presented by Lindsey Marginian, Research Finance Specialist
2 UH Lakeside, Room 1400 Register
2/22/2017 
2:00 
- 4:00 PM
IRB Walk-In Hours
Do you have questions about the IRB review process? 

Do you need help getting started in iRIS? 

The UH Clinical Trials Office can help! 

The IRB Administrative Office of the Clinical Trials Office holds regular office hours four times a month, during which staff are available for one-on-one or small group sessions. Fine tune your IRB application in real time. Get hands-on help navigating the iRIS online system. 

0 UH Lakeside, Room 1400 Register
2/23/2017 
9:00 
- 10:30 AM
How to Build a Questionnaire or Survey in REDCap (Research Electronic Data Capture)
Come learn how to build a questionnaire and/or survey in UH! REDCap (Research Electronic Data Capture). This database software is a secure web application for building and managing online surveys/questionnaires and databases. REDCap 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 Lakeside, Room 1400 Register
2/24/2017 
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
    2/28/2017 
    9:00 
    - 10:00 AM
    Informed Consent and the Decisionally Impaired Human Subject Participant
    In this presentation, we will detail the intricacies associated with consenting decisionally impaired human subject research participants. Different types of impairment will be highlighted as well as the legal implications of research with this population. 

    Presented by Dr. Barbara Daly, PhD, RN, Vice Chair, UHCMC IRB, Professor, CWRU, Director, Clinical Ethics, UHCMC
    3 UH Lerner Tower, Room 2060 Register
    2/28/2017 
    9:00 
    - 10:00 AM
    Informed Consent and the Decisionally Impaired Human Subject Participant
    In this presentation, we will detail the intricacies associated with consenting decisionally impaired human subject research participants. Different types of impairment will be highlighted as well as the legal implications of research with this population. 

    Presented by Dr. Barbara Daly, PhD, RN, Vice Chair, UHCMC IRB, Professor, CWRU, Director, Clinical Ethics, UHCMC
    3 UH Lerner Tower, Room 2060 Register
    3/2/2017 
    11:30 
    - 1:00 PM
    The Basics- An Education Series for Researchers, MODULE 7, Adverse Events and Protocol Deviations
    To define the process of Adverse Event collection and reporting definitions, policies and procedures at Seidman Cancer Center Clinical Trials Unit along with UH IRB Policies. 

    Presented by Emily Collins, MA, CCRP Clinical Research Quality Supervisor and Carrie O'Neill, BS, CCRC, Research Compliance and Education Specialist
    3 UH Lakeside, Room 1400 Register
    3/3/2017 
    11:00 
    - 1:00 PM
    IRB Walk-In Hours
    Do you have questions about the IRB review process? 

    Do you need help getting started in iRIS? 

    The UH Clinical Trials Office can help! 

    The IRB Administrative Office of the Clinical Trials Office holds regular office hours four times a month, during which staff are available for one-on-one or small group sessions. Fine tune your IRB application in real time. Get hands-on help navigating the iRIS online system. 

    0 UH Lakeside, Room 1400 Register
    3/7/2017 
    9:00 
    - 10:30 AM
    The Basics- An Education Series for Researchers, MODULE 8, 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
    0 UH Lakeside, Room 1400 Register
    3/8/2017 
    2:00 
    - 4:00 PM
    IRB Walk-In Hours
    Do you have questions about the IRB review process? 

    Do you need help getting started in iRIS? 

    The UH Clinical Trials Office can help! 

    The IRB Administrative Office of the Clinical Trials Office holds regular office hours four times a month, during which staff are available for one-on-one or small group sessions. Fine tune your IRB application in real time. Get hands-on help navigating the iRIS online system. 

    0 UH Lakeside, Room 1400 Register
    3/10/2017 
    11:30 
    - 1:00 PM
    Maintaining your IDE with the FDA: Keys for Success
    All investigators are invited to bring their staff to discuss the University Hospitals process for maintaining an investigator held Investigational Device Exemption (IDE) and will include:

  • An investigator should prepare and submit an annual renewal to the FDA
  • Items investigators need to include in the annual report to the FDA
  • How to determine when a protocol amendment should be filed with the FDA
  • Elements to be included in an amendment to the FDA
  • Filing an FDA Med Watch Report: When required, where to send it, and how to complete it
  • Tips and guidance on how to effectively respond to an FDA protocol inquiry
  • Understanding the Investigator Agreement and Form FDA 3455 and successfully updating the forms
  • Understanding FDA Guidance documents: How an investigator can keep their UH IRB and FDA approvals parallel and current


  • Presented by Jenna Stump, MS, CCRP, Manager, Center for Clinical Research and Technology
    0 UH Lakeside, Room 1400 Register
    3/13/2017 
    11:00 
    - 1:00 PM
    IRB Walk-In Hours
    Do you have questions about the IRB review process? 

    Do you need help getting started in iRIS? 

    The UH Clinical Trials Office can help! 

    The IRB Administrative Office of the Clinical Trials Office holds regular office hours four times a month, during which staff are available for one-on-one or small group sessions. Fine tune your IRB application in real time. Get hands-on help navigating the iRIS online system. 

    0 UH Lakeside, Room 1400 Register
    3/14/2017 
    9:00 
    - 10:30 AM
    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, BS, CCRC, Research Compliance and Education, Carmen Czich,RN, BSN,CCRP,Research Compliance and Education
    0 UH Lakeside, Room 1400 Register
    3/16/2017 
    11:30 
    - 1:00 PM
    Recruitment Workshop: Strategies for Successful Study Enrollment
    Did you know that nationally nearly half of study sites fail to meet their enrollment target? Approximately 10% of sites don’t enroll a single study participant! Join us at this workshop to learn the top barriers to successful study enrollment and how to overcome them. 

    Presented by Carrie O’Neill and Carmen Czich, Research Compliance and Education Specialists and Heather Tribout, Clinical Research Specialist
    0 UH Lakeside, Room 1400 Register
    3/21/2017 
    9:00 
    - 10:30 AM
    Study Visit Workshop 2: Mock Study Visit
    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, BS, CCRC, Research Compliance and Education, Carmen Czich,RN, BSN,CCRP,Research Compliance and Education
    0 UH Lakeside, Room 1400 Register
    3/22/2017 
    2:00 
    - 4:00 PM
    IRB Walk-In Hours
    Do you have questions about the IRB review process? 

    Do you need help getting started in iRIS? 

    The UH Clinical Trials Office can help! 

    The IRB Administrative Office of the Clinical Trials Office holds regular office hours four times a month, during which staff are available for one-on-one or small group sessions. Fine tune your IRB application in real time. Get hands-on help navigating the iRIS online system. 

    0 UH Lakeside, Room 1400 Register
    3/24/2017 
    11:30 
    - 1:00 PM
    The Basics: An Education Series for Researchers, MODULE 9- Avoiding Non-Compliance Findings
    We will review the top non-compliance findings and provide helpful tips and tools will be provided to help research teams prevent these significant findings. 

    Presented by Loretta Williams, MPH, CCRP, Research Compliance and Education Specialist
    3 UH Lakeside, Room 1400 Register
    3/28/2017 
    9:00 
    - 10:30 AM
    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, BS, CCRC, Research Compliance and Education, Carmen Czich,RN, BSN,CCRP,Research Compliance and Education
    0 UH Lakeside, Room 1400 Register
    3/31/2017 
    11:00 
    - 1:00 PM
    IRB Walk-In Hours
    Do you have questions about the IRB review process? 

    Do you need help getting started in iRIS? 

    The UH Clinical Trials Office can help! 

    The IRB Administrative Office of the Clinical Trials Office holds regular office hours four times a month, during which staff are available for one-on-one or small group sessions. Fine tune your IRB application in real time. Get hands-on help navigating the iRIS online system. 

    0 UH Lakeside, Room 1400 Register
    4/4/2017 
    9:30 
    - 10:30 AM
    Data Management Basics Series: Basic 1- It's a System!
    Talking through the critical questions, the march of science, systems and diagrams. Start here to understand the entire process. 

    Presented by Carolyn Apperson-Hansen, Director, Research Concierge
    0 CWRU SOM WG-86 Register
    4/6/2017 
    11:30 
    - 1:00 PM
    The Basics- An Education Series for Researchers, MODULE 10- SEIDMAN CTSU (Cancer Trial Support Unit) and LPO (Lead Protocol Organization)
    This module will define the CTSU (Cancer Trial Support Unit) and National Clinical Trials Network Lead Protocol Organizations roles and our interaction as LAPS (Lead Academic Participating Site) members with each group. 

    Presented by LaToya Strickland, CCRP Clinical Research Data Manager
    4 UH Lakeside, Room 1400 Register
    4/11/2017 
    9:30 
    - 10:30 AM
    Data Management Basic Series- Basic 2, Research Plan
    Learn the elements of a well-developed Research Plan including an Introduction, Background, Goals, Clinical Plan, Data management Plan, Statistical Analysis Plan, Regulatory Considerations Human Subject Protections. 

    Presented by Carolyn Apperson-Hansen, Director, Research Concierge
    0 CWRU SOM WG-86 Register
    4/18/2017 
    9:30 
    - 10:30 AM
    Data Management Series, Basic 3- Building a Data Management Plan
    Outline the basic data management process and data flow. Examine the elements of a data management plan. Define individual roles, responsibilities, and access privileges. 

    Presented by Carolyn Apperson-Hansen, Director, Research Concierge
    0 CWRU SOM WG-86 Register
    4/20/2017 
    11:30 
    - 1:00 PM
    The Basics- An Education Series for Researchers, MODULE 11- Oncore Training (CANCER CTU ONLY)
    Join us for a walkthrough in Oncore from study activation to study close out. 

    Presented by LaToya Strickland, CCRP Clinical Research Data Manager
    0 UH Lakeside, Room 1400 Register
    4/21/2017 
    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 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
    4/25/2017 
    9:30 
    - 10:30 AM
    Data Management Series, Basic 4- Data Entry and Quality Control (including CRF design)
    Ensure the CRF reflects the protocol’s main points. Develop clear unambiguous questions. Discuss the development of CRF instructions. Address common design challenges and design the CRF to record data that can be used in the final study report. Develop methods to track CRFs. 

    Presented by Carolyn Apperson-Hansen, Director, Research Concierge
    0 CWRU SOM WG-86 Register
    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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