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CREC Research Seminar Upcoming Events Calendar

 
 



Upcoming Seminars

Date/Time of Event

Title/Description

Credits

Location

Spring 2016

2/9/2016
9:00
- 10:00 AM
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 SOM T503 Register
2/10/2016
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 twice 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 Lakeside 1400, UHCMC Register
2/11/2016
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 UH - Bowell A Conference Room Register
2/11/2016
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
0 WebEx Register
2/12/2016
12:00
- 4:00 PM
RESCHEDULED for 3/24/2016vGrants Accounting Training
The Center for Clinical Research and Technology’s Grants Accounting (CCRT 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 Case Medical Center and its affiliated hospitals.

Topics discussed will include:
  • The main duties and, roles and responsibilities of the department administrators and the CCRT 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.

  • Presented by members of the CCRT Grants Accounting Team
0 UH - Bowell A Conference Room Register
2/15/2016
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 twice 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 Lakeside 1400, UHCMC Register
2/16/2016
9:00
- 10:00 AM
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, Manager, Center for Clinical Research
0 SOM T503 Register
2/19/2016
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, Research Compliance and Education Specialist, Center for Clincial Research and Technology, University Hospitals Case Medical Center
3 RB&C Community Room Register
2/23/2016
9:00
- 10:00 AM
Emergency Use and Expanded Access IND’s: Compare and Contrast Session
This session will go over 21 CFR 312.305, and 21 CFR 312.310 discussing the requirements for both Emergency Use and Expanded Access; their differences and similarities; how the FDA gives authorization; and reporting requirements.

Presented by Jenna Stump, MS, CCRP, Manager, Center for Clinical Research
0 SOM T503 Register
2/24/2016
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 twice 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 Lakeside 1400, UHCMC Register
3/1/2016
9:00
- 10:00 AM
Closing and/or Transferring an IND
All investigators are invited to bring their staff to discuss the process for closing and/or transferring of an investigator held Investigational New Drug (IND) Application within UH. UH Research SOP GA 106: Transfer of Protocols Into UH; GA:107 Transfer of Protocols Out of UH) will be discussed.

Presented by Jenna Stump, MS, CCRP, Manager, Center for Clinical Research
0 SOM T503 Register
3/3/2016
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 twice 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 Lakeside 1400, UHCMC Register
3/4/2016
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 - Bowell A Conference Room Register
3/7/2016
9:00
- 10:00 AM
REDCap Workshop
BRING YOUR LAPTOPS AND YOUR QUESTIONS TO THIS WORKSHOP!

This will be an open forum for anyone who has REDCap questions on the projects they are working on, or any general questions on the REDCap software itself and how to use it. It is intended to be a working session, where you bring your own materials to this workshop! In addition to your own questions, we will discuss how to create questionnaires, inputting and exporting data, building a case report form (CRF) and more! We will be doing a walk-through from start to finish of creating a simple data entry form classic project.

Presented by Sheree Hemphill, MS DCRU Informatics Manager, CTSC Biomedical Informatics Core
0 UH RB&C Amphitheater Register
3/9/2016
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 twice 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 Lakeside 1400, UHCMC Register
3/10/2016
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. Presented by Jason Soltis, MBA, Research Finance Specialist
3 UH - Bowell A Conference Room Register
3/10/2016
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. Presented by Jason Soltis, MBA, Research Finance Specialist
3 UH - Bowell A Conference Room Register
3/10/2016
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
0 WebEx Register
3/14/2016
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 twice 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 Lakeside 1400, UHCMC Register
3/18/2016
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,CCRP,Compliance and Education Specialist
3 UH - Bowell A Conference Room Register
3/23/2016
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 twice 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 Lakeside 1400, UHCMC Register
3/24/2016
9:00
- 10:00 AM
Improving 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 - Bowell A Conference Room Register
3/24/2016
12:00
- 4:00 PM
Grants Accounting Training
The Center for Clinical Research and Technology’s Grants Accounting (CCRT 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 Case Medical Center and its affiliated hospitals.

Topics discussed will include:
  • The main duties and, roles and responsibilities of the department administrators and the CCRT 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.

  • Presented by members of the CCRT Grants Accounting Team
0 WO Walker Building Auditorium Register
3/29/2016
10:00
- 11:00 AM
Residents and Fellows Training: Getting Approved- IRB Survival Guide! for Residents and Fellows
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 RB&C Community Room Register
4/5/2016
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, MStat,Director of the Research Concierge Service
0 SOM Sears Tower T501 Register
4/6/2016
1:00
- 2:30 PM
Study Visit Workshop Series- Study Startup
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.
  • (Pre-study visit)
  • Study Feasibility assessment/ finalize project
  • Write a protocol
  • Develop an ICF
  • Budget and Contract/ Grant and Coverage Analysis
  • Prepare regulatory documents and build regulatory binder
  • Submit protocol and project to the IRB
  • Develop a source document and consider study visit checklists
  • Develop a CRF and database
  • Inventory equipment and supplies
  • Study staff access to necessary systems- REDCap, Oncore, S: drive, LMS training, EMR, e- data capture, etc.)- and whom to contact
  • Register with clinicaltrials.gov
  • Site Initiation Visit/ Study kickoff meeting
  • Training Plan
  • PI Oversight Planning
  • Study Delegation and Responsibilities Log
  • Regulatory approval
  • Mock Study Visit
0 Lakeside 1400, UHCMC Register
4/12/2016
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, MStat,Director of the Research Concierge Service
0 SOM Sears Tower T501 Register
4/13/2016
1:00
- 7:00 AM
Study Visit Workshop Series- 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.
  • Recruitment
  • Screening
  • Informed Consent Process
  • Enrollment
  • Protocol Adherence
  • Investigational Product plan
  • Good Documentation Practices
  • Study Participant tools
  • Data entry and query resolution
  • Reporting requirements- IRB, Sponsor, Institution
  • Continuous process improvement
0 Lakeside 1400, UHCMC Register
4/14/2016
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 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
0 WebEx Register
4/15/2016
12:00
- 1:00 PM
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?

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 - Bowell A Conference Room Register
4/19/2016
9:00
- 10:00 AM
Data Management Series-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, MStat,Director of the Research Concierge Service
0 SOM Sears Tower T501 Register
4/20/2016
1:00
- 2:30 PM
Study Visit Workshop Series- Study Monitoring and Closeout Workshop
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.
  • Monitoring, Auditing, Compliance- scheduling a monitoring visit, accessing EMR, follow up letter, review with PI
  • Protocol changes
  • Continuous training
  • Data entry and query resolution
  • Continuous process improvement
  • Case studies
  • Clean data
  • Investigational product or device reconciliation
  • Data analysis and final report
  • IRB closure
  • Abstract, publications, inventions, patents
  • Record storage and archive
  • Study Close Out Checklist
0 Lakeside 1400, UHCMC Register
4/25/2016
12:00
- 1:00 PM
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 - Bowell A Conference Room Register
4/26/2016
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, MStat,Director of the Research Concierge Service
0 SOM Sears Tower T501 Register
5/3/2016
9:00
- 10:00 AM
Data Management Series-Advanced 1: 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 SOM Sears Tower T501 Register
5/6/2016
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 Karya Ottey, PhD, CIP, IRB Specialist II
3 UH - Bowell A Conference Room Register
5/10/2016
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, MStat,Director of the Research Concierge Service
3 SOM Sears Tower T501 Register
5/12/2016
9:00
- 10:00 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 Beth Hagesfeld, MS, CCRP
3 Lakeside 1400, UHCMC Register
5/12/2016
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
0 WebEx Register
5/17/2016
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, MStat,Director of the Research Concierge Service
3 SOM Sears Tower T501 Register
5/20/2016
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 - Bowell A Conference Room Register
5/23/2016
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 UH RB&C Amphitheater Register
5/24/2016
9:00
- 10:00 AM
Data Management Series-Advanced 4: Study Infrastructure Template
A template to help organize the entire study.
Presented by Carolyn Apperson, MStat,Director of the Research Concierge Service
3 SOM Sears Tower T501 Register