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

Summer 2017

6/23/2017
1:00
- 2:00 PM
CWRU IRB Biomedical Protocol Submission Process
Beginning July 3, 2017, the Case Western Reserve University Institutional Review Board (CWRU IRB) will expand its scope to accept protocols that are biomedical in nature in addition to social, behavioral and educational research protocols. Studies that take place at CWRU affiliate hospitals and/or involve patients, equipment or data at those sites will continue to be reviewed by the respective hospitals’ IRBs.

It is anticipated that this change will primarily affect CWRU researchers whose studies are not performed in hospital settings but involve some biomedical procedures.

To submit biomedically-oriented studies to the CWRU IRB researchers will use the current CWRU iRIS system to enter protocols on a revised form. This training session will provide step-by-step instructions to guide users through the new submission process.

Social and Behavioral researchers will not experience any changes when submitting protocol applications to the CWRU IRB.
0 Sears Library, Room 670 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,& Carrie O'Neill
0 UH Lakeside, Room 1400 Register
6/29/2017
3:30
- 4:30 PM
CWRU IRB Biomedical Protocol Submission Process
Beginning July 3, 2017, the Case Western Reserve University Institutional Review Board (CWRU IRB) will expand its scope to accept protocols that are biomedical in nature in addition to social, behavioral and educational research protocols. Studies that take place at CWRU affiliate hospitals and/or involve patients, equipment or data at those sites will continue to be reviewed by the respective hospitals’ IRBs.

It is anticipated that this change will primarily affect CWRU researchers whose studies are not performed in hospital settings but involve some biomedical procedures.

To submit biomedically-oriented studies to the CWRU IRB researchers will use the current CWRU iRIS system to enter protocols on a revised form. This training session will provide step-by-step instructions to guide users through the new submission process.

Social and Behavioral researchers will not experience any changes when submitting protocol applications to the CWRU IRB.
0 Sears Library, Room 670 Register
6/30/2017
1:00
- 2:00 PM
CWRU IRB Biomedical Protocol Submission Process
Beginning July 3, 2017, the Case Western Reserve University Institutional Review Board (CWRU IRB) will expand its scope to accept protocols that are biomedical in nature in addition to social, behavioral and educational research protocols. Studies that take place at CWRU affiliate hospitals and/or involve patients, equipment or data at those sites will continue to be reviewed by the respective hospitals’ IRBs.

It is anticipated that this change will primarily affect CWRU researchers whose studies are not performed in hospital settings but involve some biomedical procedures.

To submit biomedically-oriented studies to the CWRU IRB researchers will use the current CWRU iRIS system to enter protocols on a revised form. This training session will provide step-by-step instructions to guide users through the new submission process.

Social and Behavioral researchers will not experience any changes when submitting protocol applications to the CWRU IRB.
0 Sears Library, Room 670 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
7/12/2017
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, Manager, Research Compliance and Education, and Heather Tribout, Clinical Research 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
CANCELLED: 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
8/9/2017
11:00
- 12:30 PM
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
CANCELLED: 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
8/25/2017
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
8/29/2017
9:00
- 10:30 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. Cynthia Griggins, PhD, Assistant Clinical Professor, Neurology, CWRU School of Medicine
3 UH Lakeside, Room 1400 Register

Fall 2017

9/13/2017
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, Research Compliance and Education Specialist
3 UH Lakeside, Room 1400 Register
9/13/2017
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, Research Compliance and Education Specialist
3 UH Lakeside, Room 1400 Register
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
9/20/2017
11:30
- 1:00 PM
REDCap 101
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
9/21/2017
11:30
- 1:00 PM
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
    3 UH Lakeside, Room 1400 Register
    9/26/2017
    9:00
    - 10:30 AM
    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
    9/28/2017
    1:00
    - 4:00 PM
    Grants Accounting Training
    The UH Clinical Research Center (UHCRC) Grants Accounting (GA) team is offering a custom training and education session that covers all aspects of grants accounting. The training is designed for new and experienced grant administrators, practice administrators, department administrators and individuals who are responsible for managing grant awards established at University Hospitals Cleveland Medical Center and its affiliated hospitals.

    Topics discussed will include:
    • The main duties and, roles and responsibilities of the department administrators and the UHCRC GA team to effectively manage grant awards at UH.
    • Hands-on demonstration of the building blocks of the grants management process from Award Setup to Award Closeout.

    • This training will not be offered via WebEx; in person only.

      Presented by members of the UHCRC Grants Accounting Team
    0 UH Bolwell Conference Room A Register
    10/3/2017
    9:00
    - 10:30 AM
    Ethics of Clinical Research
    This presentation takes a look at how to become knowledgeable on ethical issues related to research and how to address them. Other topics discussed will be:

  • Recognize best practices in clinical research
  • Explore issues related to ethics and professionalism in the conduct of clinical research

  • Presented by Dr. Lydia Furman, Chairperson Department of Pediatrics Clinical Research Review Committee, Vice-Chairperson, Institutional Review Board, University Hospitals Cleveland Medical Center
    3 UH Lakeside, Room 1400 Register
    10/5/2017
    9:00
    - 10:30 AM
    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
    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
    10/13/2017
    9:00
    - 10:30 AM
    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. Steven Strausbaugh, FCCP, CPI, Associate Professor Internal Medicine and Pediatrics
    3 UH Lakeside, Room 1400 Register
    10/17/2017
    9:00
    - 10:30 AM
    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 Lakeside, Room 1400 Register
    10/20/2017
    8:30
    - 4:30 PM
    UH Clinical Research Orientation
    he 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 Collin Tubic in the Office of Research Compliance and Education at Collin.Tubic@uhhospitals.org or 216-844-7018 or register through LMS.
    6 UH Bolwell Conference Room A Register
    10/27/2017
    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 Staff
    0 UH Lakeside, Room 1400 Register
    11/2/2017
    9:00
    - 10:30 AM
    The Basics- An Education Series for Researchers, MODULE 1, 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
    3 UH Lakeside, Room 1400 Register
    11/9/2017
    11:30
    - 1:00 PM
    Informed Consent Workshop
    Join 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 UH IRB Staff
    0 UH Lakeside, Room 1400 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
    11/16/2017
    9:00
    - 10:30 AM
    The Basics- An Education Series for Researchers: Module 2, 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, Manager, Research Education, Compliance and Community Outreach
    3 UH Lakeside, Room 1400 Register
    12/6/2017
    11:30
    - 1:00 PM
    The Basics- An Education Series for Researchers: MODULE 3- 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 Carrie O'Neill
    0 UH Lakeside, Room 1400 Register
    12/8/2017
    9:30
    - 11:00 AM
    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
    12/14/2017
    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 Collin Tubic in the Office of Research Compliance and Education at Collin.Tubic@uhhospitals.org or 216-844-7018 or register through LMS.
    6 UH Bolwell Conference Room A Register
    12/28/2017
    9:00
    - 10:30 AM
    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