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

Summer 2015

8/7/2015
9:00
- 10:00 AM
Regulatory Binder and Essential Documents
Are you responsible for maintaining all the required regulatory documents for your research study? Are you unclear what documents you need to maintain in your regulatory binder?

During this session, the UH Office of Research Compliance and Education will walk through an example of essential regulatory documents and 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 creating one.
Presented by Carmen Czich, RN, BSN,CCRP, Compliance and Education Specialist, CCRT, UHCMC
3 UH RB&C Amphitheater Register
8/12/2015
10:00
- 11:00 AM
Designing a Chart Review Study
This course covers the specific requirements for submission of this unique category of research.

Presented by Beth Hagesfeld, MA, CCRP, IRB Specialist II
3 UH RB&C Amphitheater Register
8/13/2015
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/2922425306025274369

Presented by Catherine Gregor, MBA, CCRP, CCRC Project Manager, ResearchMatch, Vanderbilt University
0 WebEx Register
8/20/2015
8:00
- 9:00 AM
CANCELLED: Protocol Writing: Piecing Together a Device Application
For those investigators and research personnel planning to conduct an investigational device exemption application with the FDA; this session will provide details on the nuances of protocol writing for the FDA, helpful tips on what FDA reviewers will need to see in order to grant approval, essential elements relating to risk analysis/safety for protocol inclusion, correct way to compile a device description packet, and ways to ensure scientific soundness when piecing together your protocol.

Presented by Jenna Stump, MS, CCRP and Joseph Rutter, BS.
0 UH RB&C Amphitheater Register
8/21/2015
10:00
- 11:00 AM
CANCELLED: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 RB&C Amphitheater Register
8/24/2015
12:00
- 1:00 PM
Human Subjects Research and 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 Joseph Gibbons, MD, UHCMC IRB Chair; Assistant Professor of Medicine, Division of Hematology/Oncology
3 UH RB&C Amphitheater Register
8/28/2015
9:00
- 10:00 AM
Top Common Non-Compliance Findings
The UHCMC Office of Research Compliance and Education will review the top non-compliance findings identified through monitoring of clinical research. Helpful tips and tools will be provided to help research teams prevent these significant findings.

Presented by Loretta Williams, MPH, CCRP Compliance and Education Specialist
3 UH RB&C Amphitheater Register

Fall 2015

9/10/2015
8:00
- 9:00 AM
Residents and Fellows Training: Getting Approved-IRB Survival Guide
This session is ideal for residents, fellows, students, new researchers, and their advisors. Research Coordinators and Regulatory Specialists can also benefit from attending!

Tips for obtaining IRB approval will be reviewed at this session. A step by step guide to starting out. Some questions we will answer: How long does it take? What is the overall process? iRIS tips and tricks. Presented by Lydia Furman, MD, Chairperson, Department of Pediatrics Clinical Research Review Committee, Vice-Chairperson Institutional Review Board, University Hospitals Case Medical Center
3 UH RB&C Amphitheater Register
9/10/2015
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/2922425306025274369

Presented by Catherine Gregor, MBA, CCRP, CCRC Project Manager, ResearchMatch, Vanderbilt University
0 WebEx Register
9/23/2015
12:00
- 1:30 PM
An Introduction to UH REDCap (Research Electronic Data Capture) Software
Come learn about UH! REDCap (Research Electronic Data Capture). This database software is a secure web application for building and managing online surveys and databases and 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 RB&C Amphitheater Register
9/24/2015
9:00
- 10:00 AM
Submitting a Continuing Review Application and Closure Form to the UH IRB using iRIS
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 April Smith, BS, CCRP, IRB Specialist II, Center for Clinical Research and Technology
3 UH RB&C Amphitheater Register
9/28/2015
12:00
- 1:00 PM
Understanding Emergency Use of Investigational Drugs, Biologics or Devices
During this session, participants will learn about the Emergency Use of Investigational Drugs, Biologics, or Devices. The discussion will include investigator responsibilities, IRB responsibilities and the criteria allowing for the emergency use of a test article.

This session will be lead by Joseph Gibbons, MD, UHCMC IRB Chair; Assistant Professor of Medicine, Division of Hematology/Oncology. Time will be available at the end of the session to ask your questions.
3 UH RB&C Amphitheater Register
9/29/2015
9:00
- 10:00 AM
Data Management 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, MStat, Director of the Research Concierge Service
0 Lakeside 1400, UHCMC Register
9/30/2015
12:00
- 1:00 PM
Event Reporting: Understanding Adverse Events, Unanticipated Problems and Protocol Deviations
This session will define and discuss reporting requirements of adverse events, protocol deviations and unanticipated problems per the UH Institutional Review Board's (IRB) policies.

Case studies will be used to illustrate the reporting requirements and tools to assist in capturing this information will be reviewed. Proper reporting of events to the IRB is critical to protecting the safety and welfare of research participants.

Presented by Loretta Williams, MPH,CCRP,Compliance and Education Specialist II
3 UH RB&C Amphitheater Register
10/6/2015
9:00
- 10:00 AM
Data Management 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, MStat,Director of the Research Concierge Service
0 Lakeside 1400, UHCMC Register
10/8/2015
8:00
- 11:00 AM
CANCELLED: How Do You Know When an IND is Required? Application Submission Steps
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, CCRC and Joseph Rutter, BS
    0 Kulas Auditorium, UHCMC Register
    10/12/2015
    9:00
    - 10:00 AM
    Research Documentation- The Nuts and Bolts
    This session provides an overview of the fundamentals of research documentation, including, source documents, CRFs, essential regulatory documents required under ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) and FDA regulations, storage and retention requirements for research data and tips for organizing and maintaining your research records.

    Presented by Carrie O'Neill, BS, CCRC, Compliance and Education Specialist, CCRT, UHCMC
    3 UH RB&C Amphitheater Register
    10/13/2015
    9:00
    - 10:00 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, MStat, Director of the Research Concierge Service
    0 Lakeside 1400, UHCMC Register
    10/15/2015
    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 Bolwell A Conference Room Register
    10/20/2015
    9:00
    - 10:00 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, MStat,Director of the Research Concierge Service
    0 Lakeside 1400, UHCMC Register
    10/22/2015
    8:00
    - 9:00 AM
    CANCELLED: 510(ks): What to know before you embark on an application
    This session will provide information for investigators who plan to market their device or prove equivalence with an already approved device. Information will be given on the differences between 510k and PMA, how to prepare a 510k application, understanding when enough information has been obtained to submit a 510k, and timeframes associated with the submission and approval of a 510k application.
    Presented by Jenna Stump, MS, CCRC and Joseph Rutter, BS
    0 Lakeside 1400, UHCMC Register
    10/23/2015
    12:00
    - 1:00 PM
    Improving the Informed Consent and Eligibility Confirmation Process
    This session covers a general overview of the Informed Consent Process and frequently asked questions. Please bring your own questions and examples from studies you are involved with to help us understand and develop our skills. Particular emphasis will be placed on confirming eligibility prior to performing any study procedures.

    Presented by Carrie O'Neill, BS, CCRP,Research Compliance and Education Specialist
    3 UH RB&C Amphitheater Register
    10/27/2015
    9:00
    - 10:00 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, MStat, Director of the Research Concierge Service
    3 Lakeside 1400, UHCMC Register
    10/29/2015
    8:00
    - 9:00 AM
    CANCELLED:Maintaining your IND with the FDA: Keys for Success
    All investigators are invited to bring their staff to discuss the UHCMC process for maintaining an investigator held Investigational New Drug (IND) Application and will 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. Filing an FDA Safety 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 Forms FDA 1571, 3455, and1572 and successfully updating them.
  • Understanding FDA Guidance documents: How investigators can keep their UH IRB and FDA approvals parallel and current.

  • Presented by Jenna Stump, MS, CCRC and Joseph Rutter, BS
    0 Lakeside 1400, UHCMC Register
    11/3/2015
    1:00
    - 2:00 AM
    Top Common Non-Compliance Findings
    The UHCMC Office of Research Compliance and Education will review the top non-compliance findings identified through monitoring of clinical research. Helpful tips and tools will be provided to help research teams prevent these significant findings.

    Presented by Loretta Williams, MPH, CCRP Compliance and Education Specialist
    3 Lerner Tower, Room 2060 Register
    11/3/2015
    9:00
    - 10:00 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, MStat, Director of the Research Concierge Service
    3 Lakeside 1400, UHCMC Register
    11/10/2015
    9:00
    - 10:00 AM
    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, MStat, Director of the Research Concierge Service
    3 Lakeside 1400, UHCMC Register
    11/12/2015
    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/2922425306025274369

    Presented by ResearchMatch Program Manager, Vanderbilt University
    0 WebEx Register
    11/17/2015
    9:00
    - 10:00 AM
    Data Management Series Advanced 4: Study Infrastructure Template
    A template to help organize the entire study.
    Presented by Carolyn Apperson, MStat, Director of the Research Concierge Service
    3 Lakeside 1400, UHCMC Register
    11/23/2015
    12:00
    - 1:00 PM
    Regulatory Binder and Essential Documents
    Are you responsible for maintaining all the required regulatory documents for your research study? Are you unclear what documents you need to maintain in your regulatory binder?

    Presented by Carrie O'Neill, BS, CCRC, Compliance and Education Specialist, CCRT, UHCMC During this session, the UH Office of Research Compliance and Education will walk through an example of essential regulatory documents and 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 creating one.

    Presented by Carrie O'Neill, BS, CCRC, Compliance and Education Specialist, CCRT, UHCMC
    3 Kulas Auditorium, UHCMC Register
    12/7/2015
    12:00
    - 1:00 PM
    An Introduction to UH REDCap (Research Electronic Data Capture) Software
    Come learn about UH! REDCap (Research Electronic Data Capture). This database software is a secure web application for building and managing online surveys and databases and 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 Lakeside 1400, UHCMC Register
    12/9/2015
    9:00
    - 10:00 AM
    Event Reporting: Understanding Adverse Events, Unanticipated Problems and Protocol Deviations
    This session will define and discuss reporting requirements of adverse events, protocol deviations and unanticipated problems per the UH Institutional Review Board's (IRB) policies.

    Case studies will be used to illustrate the reporting requirements and tools to assist in capturing this information will be reviewed. Proper reporting of events to the IRB is critical to protecting the safety and welfare of research participants.

    Presented by Loretta Williams, MPH, Compliance and Education Specialist
    3 Lerner Tower, Room 2060 Register
    12/10/2015
    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://student.gototraining.com/r/6850108431737965824

    Presented by ResearchMatch Program Manager, Vanderbilt University
    0 WebEx Register
    12/14/2015
    12:00
    - 1:00 PM
    New Protocol Submissions - Getting Started with the IRB and iRIS
    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 April Smith, BA, CCRP
    3 Lakeside 1400, UHCMC Register