Date: September 25, 2014
Time: Noon - 1 p.m.
Location: FAC 426HH
Reviewing research involving medical devices is challenging – ethical principles, regulatory requirements, and device documentation issues abound. This presentation breaks down the complexities to provide an understanding of medical devices as used in clinical trials. We will cover:
- Regulations governing medical device research in the U.S. and Canada
- Terms such as Class 1, 510(k), PMA, IDE, NSR, Exempt, Licensed, and ITA
- Special considerations for combination products, humanitarian use devices, in vitro diagnostics, and adaptive clinical trials
Date: October 15, 2014
Time: 3 - 4:30 p.m.
Location: FAC 328
Departmental Review Chairs/Committees (DRCs) will meet in a Workshop hosted by the Office of Research Support (ORS) to:
- review and enhance the efficiency of the IRB submission process
- to learn about important IRB updates
- to share ideas, expertise, and network with other DRCs; and
- to provide the ORS with important feedback to assist those with their roles as DRC.
AAHRPP Webinar - Reportable Events: Developing Policies and Procedures to Guide HRPPs from the Initial Evaluation to Final Reporting
October 30, 2014
Date: October 30, 2014
Time: 2:30 - 4 p.m.
Location: FAC 426HH
This area of the regulations and guidance by the Department of Health and Human Services remains one of the most difficult areas for HRPPs to master. What do investigator’s need to report to the IRB? What procedures should IRB’s follow to evaluate these events? This webinar will describe the challenges, and offer some methods for improving outcomes including specific examples of methods employed by AAHRPP-accredited organizations. The presentation will include tools and strategies for HRPPs to follow from the first discovery of non-compliance or unanticipated problems involving risk to participants (including reports of protocol deviations), to assist them in investigating, reviewing and reporting these events.
Investigators submitting full board proposals are no longer required to submit 20 paper copies of their submission packets. Researchers are requested to submit one paper or electronic copy (pdf only) of their entire proposal to the Office of Research Support by the submission deadline.
Paper Submission Information:
Office of Research Support
Building and Room: FAC 426
Campus Mail Code: A3200
Electronic Submission (pdf only): email@example.com
If you have any questions about this change, please contact the IRB Program Coordinator assigned to your department.
Note: This archive is maintained for reference purposes. All listed events have already taken place.