Office of Research and Technology Management
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CREC Research Seminar Upcoming Events Calendar

 
 



Upcoming Seminars

Date/Time of Event

Title/Description

Credits

Location

Spring 2016

5/31/2016
9:00
- 10:00 AM
Data Management Series-Advanced 3: 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 Sears Tower, Room T501 Register

Summer 2016

6/1/2016
11:00
- 1:00 PM
IRB Office Hours
Do you have questions about the IRB review process?

Do you need help getting started in iRIS?

The Center for Clinical Research and Technology (CCRT) can help!

The IRB Administration Office of the CCRT 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
6/3/2016
10:00
- 11:00 AM
Chart Review and Discarded Tissue Studies
This course covers the specific requirements for submission of this unique category of research.
Presented by Karya Ottey,PhD, CIP, IRB Specialist II
0 UH Bolwell Conference Room A Register
6/6/2016
2:00
- 4:00 PM
IRB Office Hours
Do you have questions about the IRB review process?

Do you need help getting started in iRIS?

The Center for Clinical Research and Technology (CCRT) can help!

The IRB Administration Office of the CCRT 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
6/7/2016
9:00
- 10:00 AM
Data Management Series-Advanced 4: 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 Sears Tower, Room T501 Register
6/9/2016
10:00
- 11:00 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.

3 UH RB&C Community Room Register
6/9/2016
3:00
- 4:00 PM
How to Use Research Match 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
0 WebEx Register
6/16/2016
11:00
- 1:00 PM
IRB Office Hours
Do you have questions about the IRB review process?

Do you need help getting started in iRIS?

The Center for Clinical Research and Technology (CCRT) can help!

The IRB Administration Office of the CCRT 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
6/20/2016
1:00
- 2:00 PM
Research Billing Compliance - How to and Why
This session will provide an overview of the entire billing process from patient registration through claim resolution. Learn about the positive impact coverage analysis has on your stduy budget and in streamlining the charge reconciliationprocess. Topics include:

  1. Research Patient Scheduling
  2. Required CCRT Notification
  3. Utilization of the shared drive for patient study lists and coverage analysis
  4. Patient Billing Questions


  5. Who should attend: Clinical Research Coordinators, Managers, Research Financial Support Staff, and any clinical staff who interact with research patients.
3 UH Bolwell Conference Room A Register
6/24/2016
2:00
- 4:00 PM
IRB Office Hours
Do you have questions about the IRB review process?

Do you need help getting started in iRIS?

The Center for Clinical Research and Technology (CCRT) can help!

The IRB Administration Office of the CCRT 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
6/28/2016
12:00
- 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.

3 UH RB&C Amphitheater Register
6/30/2016
9:30
- 10:30 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.
3 UH Lerner Tower, Room 2060 Register
7/7/2016
11:00
- 1:00 PM
IRB Office Hours
Do you have questions about the IRB review process?

Do you need help getting started in iRIS?

The Center for Clinical Research and Technology (CCRT) can help!

The IRB Administration Office of the CCRT 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
7/13/2016
2:00
- 4:00 PM
IRB Office Hours
Do you have questions about the IRB review process?

Do you need help getting started in iRIS?

The Center for Clinical Research and Technology (CCRT) can help!

The IRB Administration Office of the CCRT 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
7/14/2016
9:30
- 10:30 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 Community Room Register
7/14/2016
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 in which to participate

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 Loretta Byrne, RN, MS, CCRP, Research Services Consultant II, Vanderbilt University
0 WebEx Register
7/18/2016
11:00
- 1:00 PM
IRB Office Hours
Do you have questions about the IRB review process?

Do you need help getting started in iRIS?

The Center for Clinical Research and Technology (CCRT) can help!

The IRB Administration Office of the CCRT 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
7/21/2016
9:30
- 10:30 AM
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, BS, CCRC, IRB Specialist

3 UH RB&C Amphitheater Register
7/25/2016
10:00
- 11:00 AM
Informed Consent Series: The Decisionally Impaired Human Subject Research Participant
In this part of the Informed Consent Series, 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 Bolwell Conference Room A Register
7/26/2016
9:30
- 10:30 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?

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 UH Bolwell Conference Room A Register
7/27/2016
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
7/29/2016
2:00
- 4:00 PM
IRB Office Hours
Do you have questions about the IRB review process?

Do you need help getting started in iRIS?

The Center for Clinical Research and Technology (CCRT) can help!

The IRB Administration Office of the CCRT 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
8/2/2016
9:00
- 10:30 AM
The Basics- An Education Series for Researchers: Module 1- Adverse Events and 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, Manager, Research Operations and Carrie O'Neill, BS,CCRC, Research Compliance and Education Specialist
4 UH Seidman Cancer Center, Learning Lab Register
8/4/2016
9:30
- 10:30 AM
Submitting Protocol Amendments, Revisions and Attachments to the UH IRB using iRIS
This session walks through the process of amending an approved study and revising and attaching documents in iRIS.

Presented by Elizabeth Hagesfeld, MA,CCRP, IRB Specialist III
0 UH RB&C Amphitheater Register
8/12/2016
10:30
- 11:30 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 Community Room Register
8/19/2016
2:30
- 4:00 PM
The Basics- An Education Series for Researchers: Module 2- Source 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.

Some learning objectives of this presentation are as follows:
  • Understand why accurate source documentation is essential to clinical research
  • Identify types of source documentation
  • Understand differences between medical record and research record documentation
  • Discuss what constitutes data management activities in clinical research.
  • Understand quality measures as they relate to data management


  • Presented by LaToya Strickland, CCRP, Clinical Research Data Manager and Carrie O'Neill, BS, CCRC, Research Compliance and Education Specialist
3 UH Lerner Tower, Room 2060 Register
8/23/2016
9:30
- 10:30 AM
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 Carmen Czich, RN, BSN, CCRP, Clinical Research Nurse Specialist, Center for Clincial Research and Technology, University Hospitals Case Medical Center
3 UH Bolwell Conference Room A Register

Fall 2016

9/7/2016
11:00
- 1:00 PM
IRB Office Hours
Do you have questions about the IRB review process?

Do you need help getting started in iRIS?

The Center for Clinical Research and Technology (CCRT) can help!

The IRB Administration Office of the CCRT 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
9/8/2016
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 Loretta Byrne, RN, MS, CCRP, Research Services Consultant II, Vanderbilt University
0 WebEx Register
9/9/2016
12:00
- 1:00 PM
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
9/12/2016
2:00
- 4:00 PM
IRB Office Hours
Do you have questions about the IRB review process?

Do you need help getting started in iRIS?

The Center for Clinical Research and Technology (CCRT) can help!

The IRB Administration Office of the CCRT 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
9/13/2016
9:00
- 10:00 AM
FDA Guidance Core Lecture Series: 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
4 Sears Tower, Room T501 Register
9/16/2016
8:00
- 9:30 AM
Clinical Research Forum
Clinical Research Forum is driven by the needs of the clinical research community and the goal is to find solutions to practical issues and develop process improvement initiatives. We invite all members of the research community to join us as we discuss timely research topics and provide a forum for networking as we collaborate to drive discovery at University Hospitals Case Medical Center.

Please submit suggested topics of discussion to Carrie O'Neill via email at Carrie.ONeill@uhhospitals.org.

Participants can attend in person,or Webex. Access information will be sent to registants before the event.
0 UH Bolwell Conference Room A Register
9/16/2016
2:30
- 4:00 PM
The Basics- An education Series for Researchers: MODULE 3- Response Evaluation
Assessing response to therapy allows for prospective end point evaluation in clinical trials and serves as a guide for decision making for clinicians and patients/study subjects. In oncology clinical trials, there are several standards that are used, including the RECIST criteria in solid tumors. This module will define the standard response criteria in oncology clinical trials and process for obtaining response at Seidman Cancer Center Clinical Trials Unit.

Presented by LaToya Strickland, CCRP, Clinical Research Data Manager
0 UH Seidman Cancer Center, Learning Lab Register
9/20/2016
9:00
- 10:00 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 Sears Tower, Room T501 Register
9/23/2016
11:00
- 1:00 PM
IRB Office Hours
Do you have questions about the IRB review process?

Do you need help getting started in iRIS?

The Center for Clinical Research and Technology (CCRT) can help!

The IRB Administration Office of the CCRT 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
9/27/2016
9:00
- 10:00 AM
FDA Guidance Core Lecture Series: 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
3 Sears Tower, Room T501 Register
9/27/2016
12:00
- 1:00 PM
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 Case Medical Center
    0 UH RB&C Amphitheater Register
    9/29/2016
    2:00
    - 4:00 PM
    IRB Office Hours
    Do you have questions about the IRB review process?

    Do you need help getting started in iRIS?

    The Center for Clinical Research and Technology (CCRT) can help!

    The IRB Administration Office of the CCRT 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