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

Spring 2017

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
4/27/2017
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 Research Center can help!

The IRB Administrative Office of the Clinical Research Center 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
4/28/2017
9:00
- 5:00 PM
Clinical Research Orientation
Clinical Research Orientation 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 register through LMS.
6 UH RB&C Amphitheater 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
5/3/2017
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 Research Center can help!

The IRB Administrative Office of the Clinical Research Center 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
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
5/8/2017
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 Research Center can help!

The IRB Administrative Office of the Clinical Research Center 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
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
5/9/2017
12:30
- 2:00 PM
Diversity in Research
Diversity in Research explores the scientific, ethical, and legal bases for the inclusion of diverse participants in research and the recruitment and hiring of diverse research staff. Potential barriers to diversity in the research context are discussed.

4 Wolstein Research Building, Room 1403 Register
5/11/2017
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
5/12/2017
9:30
- 11:00 AM
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, FDA Guidance Specialist
    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
    5/18/2017
    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 Research Center can help!

    The IRB Administrative Office of the Clinical Research Center 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
    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 CWRO SOM WG-82C Register
    5/24/2017
    10:00
    - 12:00 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 Research Center can help!

    The IRB Administrative Office of the Clinical Research Center 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
    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
    5/29/2017
    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 Research Center can help!

    The IRB Administrative Office of the Clinical Research Center 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

    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
    oin 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 April Smith and Janet Peachey, IRB Specialists
    0 UH Lakeside, Room 1400 Register
    6/7/2017
    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 Research Center can help!

    The IRB Administrative Office of the Clinical Research Center 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
    6/9/2017
    9:30
    - 11:00 AM
    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
    6/12/2017
    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 Research Center can help!

    The IRB Administrative Office of the Clinical Research Center 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
    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
    6/21/2017
    10:00
    - 12:00 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 Research Center can help!

    The IRB Administrative Office of the Clinical Research Center 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
    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'Neill@UHhospitals.org or 216-286-2283 or register through LMS.
    6 UH Bolwell Conference Room A Register
    6/26/2017
    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 Research Center can help!

    The IRB Administrative Office of the Clinical Research Center 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
    6/27/2017
    9:00
    - 10:30 AM
    The Basics- An Education Series for Researchers: MODULE 2- 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
    7/6/2017
    11:30
    - 1:00 PM
    The Basics- An Education Series for Researchers: Module 3 - Prescreening, eligiblity and enrollment
    This module will define the process of pre-screening, eligibility review and verification and enrollment for subjects enrolled at University Hospitals.

    Presented by Mary Corl, RN, BSN,CCRC Oncology Clinical Operations Manager and Carmen Czich, RN, BSN, CCRP Research Compliance & Education Specialist
    3 UH Lakeside, Room 1400 Register
    7/11/2017
    9:00
    - 10:30 AM
    The Basics- An Education Series for Researchers: MODULE 4, Informed Consent & Reconsent
    This presentation will help to define the guiding principles of the informed consent process, forms used during process and documentation of re-consent.

    Presented by Carrie O'Neill, Research Compliance and Education Specialist
    4 UH Lakeside, Room 1400 Register
    7/13/2017
    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
    7/14/2017
    9:30
    - 11:00 AM
    Maintaining your IND and Investigator Brochure with the FDA
    All investigators are invited to bring their staff to discuss the UHCMC process for maintaining an investigator held Investigational New Drug (IND) Application and Investigator Brochure. Topics of discussion include:
    • How 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; tips and guidance on how to effectively respond to an FDA protocol inquiry.
    • The Investigator Brochure (IB) should be reviewed at least annually and revised as necessary in compliance with a sponsor's written procedures; in accordance with GCP, relevant new information may be so important that it should be communicated to the investigators, and possibly to the Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) and/or regulatory authorities before it is included in a revised IB.

    • Presented by Jenna Stump, MS, CCRP, Manager, Center for Clinical Research
    0 UH Lakeside, Room 1400 Register
    7/18/2017
    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
    7/25/2017
    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
    7/28/2017
    11:30
    - 1:00 PM
    The Basics- An Education Series for Researchers: MODULE 5, Research Documentation and Data Management
    Documentation in clinical practice is essential for communication among healthcare providers. It is from this documentation that protocol-specific data is abstracted, submitted and analyzed.

    Clinical data management consists of various activities involving the handling of information that is outlined in the protocol to be collected / analyzed. These activities lead to the generation of high-quality, reliable and statistically sound clinical trial data.

    Presented by LaToya Strickland, CCRP Clinical Research Data Manager, Carrie O'Neill, CCRC, Research Compliance and Education
    3 UH Lakeside, Room 1400 Register
    8/1/2017
    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
    8/8/2017
    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 Research Finance Staff
    2 UH Lakeside, Room 1400 Register
    8/10/2017
    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'Neill@UHhospitals.org or 216-286-2283 or register through LMS.
    6 UH Bolwell Conference Room A Register
    8/10/2017
    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
    8/11/2017
    9:30
    - 11:00 AM
    Dietary Supplements and Vitamins: When is FDA Regulation Necessary?
    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
    0 UH Lakeside, Room 1400 Register
    8/15/2017
    9:00
    - 10:30 AM
    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
    4 UH Lakeside, Room 1400 Register
    8/17/2017
    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.

    Presented by Dr. Carl Fedor, Director, Human Subjects Protection Program and Dr. Steven Strausbaugh, FCCP, CPI, Associate Professor Internal Medicine and Pediatrics
    3 UH Lakeside, Room 1400 Register

    Fall 2017

    9/14/2017
    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
    10/12/2017
    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
    11/9/2017
    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