CREC Research Seminar Upcoming Events Calendar

 
 



Upcoming Seminars

Date/Time of Event

Title/Description

Credits

Location

Spring 2015

2/4/2015
10:00
- 11:00 AM
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 Nursing Bioinformatics Lab Register
2/5/2015
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
2/5/2015
2:00
- 3:00 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.

This session will be led by Steven Strausbaugh, MD, Assistant Professor of Pediatrics, Division of Pulmonology and Carol Fedor, ND, RN, CCRC, Director, Human Research Protection Program
3 UH RB&C Amphitheater Register
2/6/2015
8:30
- 9:30 AM
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 Toepfer Room, Adelbert Hall Register
2/9/2015
10:00
- 11:30 AM
How Do You Know When an IDE is Required? Application Submission Steps
All investigators are invited to bring their staff to discuss the University Hospitals process for obtaining an investigator held Investigational Device Exemption and will include:
  • How an investigator can determine if an IDE approval from the FDA is needed
  • The various classifications for devices
  • Different types of device submissions to the FDA and how the approval process works
  • UH policies related to the use of Investigational Devices

  • Presented by Jenna Stump, MS, CCRP, UH Clinical Research Regulatory Specialist, CCRT, UHCMC
4 Kulas Auditorium, UHCMC Register
2/9/2015
10:00
- 11:00 AM
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 KSL LL-06 Register
2/10/2015
10:00
- 11:00 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
3 Kulas Auditorium, UHCMC Register
2/10/2015
1:00
- 2:00 PM
Submitting a Pre-IDE Application to the FDA
This session is applicable for any investigator or research personnel who are unsure if the device they are working with or developing is classified as significant rick or non-significant risk. Learn the basics of submitting a Pre-IDE Application to the FDA, the differences between a significant risk vs. non significant risk device, and the nuances of device applications and submissions to the FDA.

Presented by Jenna Stump, MS, CCRP, UH Clinical Research Regulatory Specialist, CCRT, UHCMC
3 UH RB&C Amphitheater Register
2/11/2015
10:00
- 11:00 AM
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 Nursing Bioinformatics Lab Register
2/18/2015
10:00
- 11:00 AM
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 Nursing Bioinformatics Lab Register
2/18/2015
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
2/18/2015
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
2/18/2015
2:30
- 3:30 PM
Maintaining Your (IDE) with the FDA: Keys for Success
All investigators are invited to bring their staff to discuss the University Hospitals process for maintaining an investigator held Investigational Device Exemption (IDE) 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. Elements to be included in an amendment to the FDA
  5. Filing an FDA Med Watch Report: When required, where to send it, and how to complete it
  6. Tips and guidance on how to effectively respond to an FDA protocol inquiry
  7. Understanding the Investigator Agreement and Form FDA 3455 and successfully updating the forms
  8. Understanding FDA Guidance documents: How an investigator 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 Kulas Auditorium, UHCMC Register
2/20/2015
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 KSL 215 Register
2/24/2015
9:00
- 10:30 AM
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
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
3/17/2015
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
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