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CREC Research Seminar Upcoming Events Calendar

 
 



Upcoming Seminars

Date/Time of Event

Title/Description

Credits

Location

Spring 2015

3/4/2015
12:00
- 1:30 PM
Research @ CWRU: A boot camp for investigators
The Office of Research Administration welcomes all new faculty to attend this 90-minute orientation designed to help navigate the university's research grant and regulatory compliance processes and policies. Research Administration staff members will share the university’s internal procedures and attendees will receive a binder of helpful information to take away from the presentation. There will be plenty of time for questions.

New faculty are specifically invited, but all faculty are welcome to attend.

This session will include CWRU School of Medicine (SOM)-specific information and participation from the SOM Grants and Contracts Office.
0 WRB 1403 Register
3/5/2015
11:30
- 12:30 PM
PI Toolkit: How to Find and Interpret Sponsored Project Financial Statements
This session was created for faculty principal investigators who have active Sponsored Projects. Attendees will learn about financial statements that are available to them via Launchpad. We will be discussing key statements which should be reviewed on a monthly basis to ensure financial transactions occur in accordance with university and sponsor policies. Examples of reports that will be reviewed include Income and Expense Statements, Salary Analysis and Status of Funded Projects.
0 WRB 1403 Register
3/5/2015
12:00
- 1:30 PM
Everything Researchers Need to Know About Human Resources
This session will provide researchers with the opportunity to further develop and strengthen the knowledge, methods and skills necessary to meet their human resource challenges.
0 Crawford Hall, Room 209 Register
3/5/2015
2:00
- 3:00 PM
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 Karya Ottey, MA, CIP IRB Specialist II
0 UH RB&C Amphitheater Register
3/11/2015
12:00
- 1:00 PM
Closure of IRB Approved Protocols
This session will define and discuss UHCMC IRB Requirements for study closure. Included in the presentation will be a study close out checklist.

Presented by April Smith, BS IRB Specialist II
3 UH RB&C Amphitheater Register
3/12/2015
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://student.gototraining.com/r/6850108431737965824

Presented by ResearchMatch Program Manager Kathy Edson, Vanderbilt University
0 WebEx Register
3/16/2015
12:00
- 1:30 PM
Research @ CWRU: A boot camp for investigators
The Office of Research Administration welcomes all new faculty to attend this 90-minute orientation designed to help navigate the university's research grant and regulatory compliance processes and policies. Research Administration staff members will share the university’s internal procedures and attendees will receive a binder of helpful information to take away from the presentation. There will be plenty of time for questions.

New faculty are specifically invited, but all faculty are welcome to attend.

0 Toepfer Room, Adelbert Hall Register
3/17/2015
2:00
- 3:00 PM
Hands-on Introduction to the New Sparta COI System
Join the Office of Research Administration Conflict of Interests (COI) staff for an opportunity to learn about the new Sparta COI software for the annual disclosure process. Attendees can stop in for a quick tutorial of the new system, or you can complete your disclosure during the session with assistance from our COI staff.
0 Robbins Computer Lab (E324) Register
3/19/2015
9:00
- 10:00 AM
Submitting a Continuing Review Application 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 Erin Zaletel, MPH, CIP IRB Specialist III
3 UH RB&C Amphitheater Register
3/19/2015
12:00
- 1:30 PM
Everything Researchers Need to Know About Human Resources
This session will provide researchers with the opportunity to further develop and strengthen the knowledge, methods and skills necessary to meet their human resource challenges.
0 Crawford Hall, Room 209 Register
3/23/2015
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
3/26/2015
9:00
- 10:00 AM
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.

    Presented by Kathy Hammerhofer, BSN, RN, Director, Research Finance, CCRT, UHCMC
2 UH RB&C Amphitheater Register
4/7/2015
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-Hansen,Director,Research Concierge Service
0 Lakeside 1400, UHCMC Register
4/7/2015
2:30
- 3:45 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.

This workshop meets the requirements of the CWRU Office of Inclusion, Diversity, and Equal Opportunity (OIDEO) for participation on CWRU search committees.
4 BRB 105 Register
4/8/2015
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 Carmen Czich, RN, BSN, CCRP, Clinical Research Nurse Specialist, Center for Clincial Research and Technology, University Hospitals Case Medical Center
3 UH RB&C Amphitheater Register
4/9/2015
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://student.gototraining.com/r/6850108431737965824

Presented by ResearchMatch Program Manager,Kathy Edson,Vanderbilt University
0 WebEx Register
4/13/2015
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 II
3 UH RB&C Amphitheater Register
4/14/2015
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-Hansen,Director,Research Concierge Service
0 Lakeside 1400, UHCMC Register
4/15/2015
1:00
- 2:30 PM
Clinical Research Forum
This forum is for all members of the research community to discuss timely research topics. This is a great opportunity to network as we collaborate to drive discovery at UHCMC.

Topics for this forum are driven by the needs of the research community The goal is to maximize UH’s talented resources to find solutions to practical issues and develop process improvement initiatives.

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

Participants can attend in person, via phone or phone and Webex. Access information will be sent to registants before the event.
0 Kulas Auditorium, UHCMC Register
4/16/2015
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 Kulas Auditorium, UHCMC Register
4/21/2015
9:00
- 10:00 AM
Data Management-Basic 3: Building a Data Management Plan
Outline the basic data management process and data flow. Examine the elements of a data management plan. Define individual roles, responsibilities, and access privileges.

Presented by Carolyn Apperson-Hansen, Director, Research Concierge Service
0 Lakeside 1400, UHCMC Register
4/23/2015
8:00
- 4:00 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 Kulas Auditorium, UHCMC Register
4/27/2015
8:00
- 9:00 AM
Humanitarian Device Exemption (HUD): Understanding the Differences for Human Subjects Research
For investigators and research personnel who work in the area of research/investigational devices. This session will help clinical and research personnel understand what a humanitarian use device (HUD) is, does their device and patient population qualify for an HUD, how to obtain a humanitarian device exemption (HDE) with the FDA, and how to apply an HDE in a clinical setting with patients.
Presented by Jenna Stump, MS, CCRP and Joseph Rutter, BS
0 Kulas Auditorium, UHCMC Register
4/28/2015
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 Kulas Auditorium, UHCMC Register
4/28/2015
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-Hansen, Director,Research Concierge Service
0 Lakeside 1400, UHCMC Register
5/5/2015
9:00
- 10:00 AM
Data Management Series-Advanced1: 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 is the Director of the Research Concierge Service
0 Lakeside 1400, UHCMC Register
5/6/2015
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?

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
5/7/2015
8:00
- 9:00 AM
FDA Early Feasibility Route: Taking your device from start to finish with the FDA
For investigators and research personnel in the device development phase who wish to seek approval for use from the FDA in a clinical trial. This session will help those in attendance understand this specifics of the early feasibility route, the differences between the traditional IDE route, and length of time expected to go through the early feasibility route for device approval in a clinical trial. Applicable for those in biomedical engineering who may partner with clinicians for the development of a device for clinical use.
Presented by Jenna Stump, MS, CCRP and Joseph Rutter, B.S.
0 UH RB&C Amphitheater Register
5/12/2015
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-Hansen is the Director of the Research Concierge Service
0 Lakeside 1400, UHCMC Register
5/13/2015
9:00
- 10:00 AM
Chart Reviews and Discarded Tissue Studies
This course covers the specific requirements for submission of this unique category of research.
Presented by Karya Ottey, MA, CIP, IRB Specialist II
0 Kulas Auditorium, UHCMC Register
5/14/2015
9:00
- 10:00 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 RB&C Amphitheater Register
5/14/2015
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,Kathy Edson, Vanderbilt University
0 WebEx Register
5/18/2015
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 Kulas Auditorium, UHCMC Register
5/19/2015
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-Hansen is the Director of the Research Concierge Service
0 Lakeside 1400, UHCMC Register
5/26/2015
8:00
- 9:00 AM
Data Management Series-Advanced 4: Study Infrastructure Template
A template to help organize the entire study.

Presented by Carolyn Apperson-Hansen is the Director of the Research Concierge Service
0 Lakeside 1400, UHCMC Register

Summer 2015

6/1/2015
10:00
- 11:00 AM
Closure of IRB Approved Protocols
This session will define and discuss UHCMC IRB Requirements for study closure. Included in the presentation will be a study close out checklist.

Presented by Elizabeth Hagesfeld, MA Human Subjects Protection Specialist , Center for Clinical Research and Technology
3 UH RB&C Amphitheater Register
6/3/2015
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 Kulas Auditorium, UHCMC Register
6/4/2015
8:00
- 9:00 AM
Pre-clinical data: How much is enough to submit a drug or device protocol to the FDA?
This session will provide helpful insight into the level of detail that the FDA will need to see when reviewing drug or device applications for clinical trial approval. What type of testing will the FDA look to be completed prior to the submission of an IND or IDE, what product testing will need to have been completed, and the differences between GLP and GMP testing requirements by the FDA.
Presented by Jenna Stump, MS,CCRP and Joseph Rutter, BS
0 Kulas Auditorium, UHCMC Register
6/11/2015
9:00
- 10:00 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, BA, IRB Specialist II
3 UH RB&C Amphitheater Register
6/11/2015
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://student.gototraining.com/r/6850108431737965824

Presented by ResearchMatch Program Manager,Kathy Edson, Vanderbilt University
0 WebEx Register
6/15/2015
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, Compliance and Education Specialist
3 UH RB&C Amphitheater Register
6/18/2015
10:00
- 11:00 AM
Submitting a Continuing Review Application 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)?

This program will include an in-depth review of the elements required for continuing review submissions that are reviewed either by the full IRB or administratively. Tips for preventing a lapse in IRB approval will also be discussed.
Presented by Karya Ottey, MA, CIP IRB Specialist II
3 Kulas Auditorium, UHCMC Register
6/25/2015
8:00
- 9:00 AM
Part 11 Compliance and you FDA protocols: Taking into account the FDA Regulations and Applying to your research applications
Presented by Jenna Stump, MS, CCRP, and Joseph Rutter, BS
0 UH RB&C Amphitheater Register