Date/Time of Event |
Title/Description |
Credits |
Location |
|
Spring 2012 |
1/30/2012
1:30
- 3:00 PM
|
Informed Consent - Creating the Document
Are you new to creating informed consent documents for research studies? Do you struggle with converting the consent form provided by your sponsor to the UH IRB format? During this session learn tips for creating informed consent documents which meet regulatory requirements and resources available to support you. The UH IRB Informed Consent Form Tutorial document, which provides valuable information in structuring and writing your informed consent form, will also be reviewed as a tool. |
4 |
RB&C Community Room |
Register |
1/30/2012
2:00
- 4:00 PM
|
CWRU Electronic Application Process Training (SBER IRB and IBC)
This 2-hour session will introduce CWRU Social/Behavioral (SBER) IRB investigators and Institutional Biosafety Committee (IBC) investigators to our new electronic application process through an interactive training session. Investigators, administrators and students who will submit IBC or IRB applications are encouraged to attend. Staff will be available to help attendees walk through both the IRB and IBC process.
KSL LL-06 is located in the Kelvin Smith Library on the Lower Level. |
0 |
KSL LL-06 |
Register |
1/31/2012
9:00
- 10:00 AM
|
Research Billing Compliance “How To & Why”
During this session, Kathy Hammerhofer, Finance Director, Center for Clinical Research and Technology (UH Case Medical Center), 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 study budget and in streamlining the charge reconciliation process. Topics will include: research patient scheduling; required UH Center for Clinical Research and Technology notification; utilization of the shared drive for patient study lists and coverage analysis; and patient billing questions.
Who should attend: clinical research managers, research financial support staff, and any clinical staff who interact with research patients.
|
0 |
Lerner Tower, Room 2060 |
Register |
2/1/2012
2:00
- 4:30 PM
|
Study Visit Workshop
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 case report forms (CRFs),
and how to identify and report adverse events.
|
0 |
Lakeside 1400, UHCMC |
Register |
2/6/2012
2:30
- 4:00 PM
|
UH Clinical Research SOP Training
This session will provide formal training on University Hospitals Clinical Research Standard Operating Procedures (SOPs) to ensure applicable clinical research staff has an understanding of the requirements of the SOPs and the activities necessary for adherence to the SOPs.
Applicable individuals must participate in training (live or on-line through the UH Learning Management System (LMS)). If an SOP is related to an individual’s scope of practice, training must be completed. If you are unsure whether or not this applies to you, please consult your manager to determine applicability of the SOP.
This session will provide training on the following Clinical Research SOPs: 1) Development of Standard Operating Procedures (SOPs), 2) FDA Inspections of Investigators and 3) Site Initiation Visit.
|
0 |
Bolwell A Conference Room |
Register |
2/8/2012
9:00
- 10:00 AM
|
Essential Regulatory 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 & 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 putting one together.
|
0 |
Lakeside 1400, UHCMC |
Register |
2/9/2012
9:00
- 11:00 AM
|
CWRU Electronic Application Process Training (SBER IRB and IBC)
This 2-hour session will introduce CWRU Social/Behavioral (SBER) IRB investigators and Institutional Biosafety Committee (IBC) investigators to our new electronic application process through an interactive training session. Investigators, administrators and students who will submit IBC or IRB applications are encouraged to attend. Staff will be available to help attendees walk through both the IRB and IBC process.
KSL LL-06 is located in the Kelvin Smith Library on the Lower Level. |
0 |
KSL LL-06 |
Register |
2/9/2012
3:00
- 4:00 PM
|
WEBINAR: How to Use ResearchMatch as a Recruitment Tool – Researcher Training
ResearchMatch has a simple goal – to bring together two groups of people who are looking for one another: (1) people who are trying to find research studies, and (2) researchers who are looking for people to participate in their studies.
During this webinar researchers will learn step by step how to register and begin utilizing this valuable tool to increase recruitment to their studies.
|
0 |
Lakeside 1400, UHCMC |
Register |
2/9/2012
3:00
- 4:00 PM
|
Clinical Research Policies
Knowing all the polices and regulations that must be followed when conducting clinical research can seem overwhelming. One of the first steps in adhering to all these policies is knowing what needs to be done.
If you are new to clinical research at UH, or just need a refresher, come to this interactive session to learn where to find UH system and IRB polices that govern clinical research. Special emphasis will be given to UH policy R-39 Clinical Research Investigation. |
0 |
Lakeside 1400, UHCMC |
Register |
2/20/2012
11:00
- 12:00 PM
|
Human Subject Research - When is IRB Review Required? A look at Case Studies, Quality Improvement Initiatives, and Other Activities that may Require IRB Review
This session will discuss the regulations and the process of submitting a project to request a determination by the UH IRB as to whether an activity involves human subject research.
Any activities that have the potential to involve humans, living or deceased, or specimens/data obtained from humans must receive a determination from the UHCMC Center for Clinical Research and Technology (CCRT) regarding the nature of the activity and the type of review required by the IRB.
Philip Cola, MA, UH Vice President for Research and Technology will lead the discussion.
|
3 |
RB&C Community Room |
Register |
2/22/2012
9:00
- 10:30 AM
|
The Nuts and Bolts of Research Documentation
This session will provide an overview of the fundamentals that must be considered concerning research documentation, including, source documentation in clinical research, essential documentation required by ICH-GCP (International Conference on Harmonisation – Good Clinical Practice) and FDA regulations, storage and retention requirements for research data, electronic documentation and tips for organizing and maintaining your research records. |
4 |
WRB 1413 |
Register |
2/22/2012
10:45
- 12:00 PM
|
Communication and Collaboration in Resesarch: Tips and Tactics for Investigators, Students and Staff to Enhance Integrity in Research
Whether your research setting involves one faculty member and one student working together, or a laboratory team of ten or more researchers, staff and students, effective communication is going to be a key factor to the overall success of the project. But, just as the science requires careful planning and dedicated hard work, so do the research relationships. This session will provide insights, as well as practical tips and tactics which can help to ensure that all the members of the research team are communicating effectively. |
0 |
WRB 1413 |
Register |
2/22/2012
1:00
- 2:15 PM
|
Commercializing Research: Working with the Technology Transfer Office
The mission of the Technology Transfer Office (TTO) is to lead the successful commercialization of inventions developed at CWRU through licensing to existing businesses or starting new enterprises. During this presentation, TTO staff will discuss what “successful commercialization” is, the steps taken to reach that goal, and what you should consider as your research progresses. Additionally, you can expect answers to your questions on patents, confidentiality agreements, material transfer agreements and how Tech Transfer interfaces with Sponsored Projects Administration. Finally, you will leave the session with practical advice about working with the office. |
0 |
WRB 1413 |
Register |
2/22/2012
2:30
- 4:00 PM
|
Animal Research: Working Effectively with IACUC
The overall role of the Institutional Animal Care and Use Committee (IACUC) is to ensure the humane and sensitive care and use of animals in research. This session will focus on the History and Ethics of Animal Research, current regulations and functional tips. We will also provide information and tools for submitting a protocol, training requirements, protocol addenda, continuing review and post approval monitoring. |
0 |
WRB 1413 |
Register |
2/23/2012
2:00
- 3:00 PM
|
Submitting a Continuing Review Application to the UH IRB
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. This session will be lead by Karya Ottey, UH IRB Coordinator.
|
0 |
RB&C Community Room |
Register |
