CREC Research Seminar Upcoming Events Calendar

 
 



Upcoming Seminars

Date/Time of Event

Title/Description

Credits

Location

Spring 2014

4/21/2014
12:00
- 1:00 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
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