CREC Research Seminar Upcoming Events Calendar

 
 



Upcoming Seminars

Date/Time of Event

Title/Description

Credits

Location

Spring 2014

4/24/2014
2:00
- 3:30 PM
Registering your trials on ClinicalTrials.gov
The Food and Drug Administration Amendments Act of 2007 requires mandatory registration and results reporting for certain clinical trials of drugs, biologics, and devices. Is your clinical study required to be registered with ClinicalTrials.gov? Do you understand what your responsibilities are once you have registered your study?

During this session, April Firstencel, PRMC Manager, OnCore Support at Case Comprehensive Cancer Center and local expert on ClinicalTrials.gov, will answer these questions and explain in detail how to register your study on ClinicalTrials.gov. Ample time will be allotted for questions and a look at specific examples.
0 UH RB&C Amphitheater Register
4/28/2014
11:00
- 12:00 PM
Closure of UH 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 Erin Zaletel, MPH, CIP, Human Subjects Protection Specialist, Center for Clinical Research and Technology
3 UH RB&C Amphitheater Register
4/29/2014
3:00
- 4:30 PM
Reporting results for your trial on ClinicalTrials.gov
The Food and Drug Administration Amendments Act of 2007 requires mandatory registration and results reporting for certain clinical trials of drugs, biologics, and devices. Is your clinical study required to be registered with ClinicalTrials.gov? Do you understand what your responsibilities are once you have registered your study?

During this session, April Firstencel, PRMC Manager, OnCore Support at Case Comprehensive Cancer Center and local expert on ClinicalTrials.gov, will answer these questions and explain in detail how to the basics of how results are reported in ClinicalTrials.gov. Ample time will be allotted for questions and a look at specific examples.
0 UH RB&C Amphitheater Register
5/7/2014
2:00
- 3:30 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
5/9/2014
11:30
- 5:30 AM
iRIS Training - New Protocol Submissions
This session walks through the submission of a new protocol in iRIS.

Presented by IRB Staff
0 Lerner Tower, Room 2060 Register
5/16/2014
2:00
- 3:00 PM
iRIS Training - Submitting Protocol Amendments, Revisions and Attachments
This session walks through the process of amending an approved study and revising and attaching documents in iRIS.
0 UH RB&C Amphitheater Register
5/19/2014
1:30
- 3:00 PM
How Do you Know When and 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.
4 UH RB&C Amphitheater Register
5/23/2014
2:00
- 3:00 PM
iRIS Training - Submitting Continuing Reviews
This session walks through a continuing review submission.
0 Kulas Auditorium, UHCMC Register
5/27/2014
2:00
- 3:00 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.
2 UH RB&C Amphitheater Register

Summer 2014

6/2/2014
10:00
- 11:00 AM
IATA Certification Training
The IATA Dangerous Goods Regulations (DGR) is used worldwide by air carriers who accept and transport shipments of dangerous goods. All individuals involved in the handling, packaging, transporting, offering, acceptance, loading and unloading of dangerous goods must have the proper training to do so. Register for this session to receive "IATA certification".
0 RB&C Community Room Register
6/3/2014
1:30
- 2:30 PM
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 study 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
0 UH RB&C Amphitheater Register
6/4/2014
10:00
- 11:00 AM
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
6/9/2014
3:00
- 4:00 PM
Getting Started -Submitting to the IRB
Are you preparing to submit to the UH IRB? This session provides the information to get started. We will review the IRB submission process including required elements and the UHCMC IRB policy on protocol submission requirements.

Presented by April Smith, IRB Coordinator, Center for Clinical Research and Technology
3 UH RB&C Amphitheater Register
6/16/2014
3:00
- 4:00 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.

Presented by Elizabeth Hagesfeld, MA, Human Subjects Protection Specialist, Center for Clinical Research and Technology
3 UH RB&C Amphitheater Register
6/19/2014
3:00
- 4:00 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
3 UH RB&C Amphitheater Register
6/20/2014
9:30
- 11:00 AM
How Do you Know When and 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.
4 UH RB&C Amphitheater Register
6/23/2014
3:00
- 4:00 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 Erin Zaletel, MPH, CIP, Human Subjects Protection Specialist, Center for Clinical Research and Technology
3 UH RB&C Amphitheater Register
6/25/2014
4:00
- 5:00 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 Kulas Auditorium, UHCMC Register
6/27/2014
9:30
- 10:30 AM
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
3 UH RB&C Amphitheater Register