CREC Research Seminar Upcoming Events Calendar


Upcoming Seminars

Date/Time of Event




Spring 2015

- 11:00 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
- 2:30 PM
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, CCRP, UH Clinical Research Regulatory Specialist, CCRT, UHCMC
4 Kulas Auditorium, UHCMC Register
- 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:

Presented by Kathy Edson, ResearchMatch Program Manager, Vanderbilt University
0 WebEx Register
- 1:00 PM
UH Research Credentialing
UH research credentialing applies to all non-UH personnel interested in conducting research at UH. Are you confused about the process? Did you know credentialing is required annually? Review the step by step process for getting credentialed.

Presented by David Ehlert, Director of Research Operations, CCRT, UHCMC and Tracey Tytko, IRB Specialist
0 UH RB&C Amphitheater Register
- 1:00 PM
Improving the Informed Consent and Eligibility Confirmation Process
Review frequent findings with the process of informed consent and eligibility confirmation. This interactive session will use examples from studies you are involved with to help you understand and develop your skills at obtaining informed consent from potential research participants. 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, UHCMC
3 UH RB&C Amphitheater Register
- 2:30 PM
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:
  1. How an investigator should prepare and submit an annual renewal to the FDA
  2. Items investigators need to include in the annual report to the FDA
  3. How to determine when a protocol amendment should be filed with the FDA
  4. Filing an FDA Safety Report: When required, where to send it, and how to complete it
  5. Tips and guidance on how to effectively respond to an FDA protocol inquiry
  6. Understanding Forms FDA 1571, 3455, and1572 and successfully updating them
  7. Understanding FDA Guidance documents: How investigators can keep their UH IRB and FDA approvals parallel and current
Presented by Jenna Stump, MS, CCRP, UH Clinical Research Regulatory Specialist, CCRT, UHCMC
2 UH RB&C Amphitheater Register
- 3:00 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
- 5:00 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' or 216-286-2283 or register through LMS.
6 Bolwell A Conference Room Register
- 3:00 PM
Reporting results for your trial on and Workshop!
Having trouble with the registration process on Not sure where to start? Bring your laptop or study materials to a workshop! Your questions will be answered during this time.

Presented by April Firstencel,Protocol Review and Monitoring Committee (PRMC) Manager,OnCore Support& Jan Hanson,Registration Coordinator,OnCore Support
0 UH RB&C Amphitheater Register