eIRB Upgrade: Reportable New Information (RNI) Presented by Andrea Seykora, assistant research integrity officer Tuesday, Mar. 10, 2015 2 to 3 p.m. OHSU Hospital, 8th floor auditorium The new eIRB system will handle reporting of Unanticipated Problems and Protocol Deviations through a single pathway called “Reportable New Information (RNI).” In addition, the OHSU IRB is revising its policy on what items will require investigators to submit a report. This brown bag session will introduce … Read More
Posts Tagged ‘eIRB’
eIRB Upgrade: Mods & CRQs Presented by Dave Holmgren, IRB manager Thursday, Feb. 26, 2015 11:30 a.m. to 1 p.m. OHSU Hospital, 8th floor auditorium This Brown Bag will provide an overview and demonstration of the modification and continuing review submission processes in the new eIRB system. You will see the new modification and continuing review questionnaires and learn how the new system improves upon the current process.
eIRB Upgrade: Initial Submissions Presented by: Dave Holmgren, IRB Manager Wednesday, February 4, 2015 9:30 AM – 10:30 AM UHS 8B60 This is the first of many brown bags in a special series from the IRB to promote the new eIRB upgrade, releasing later this year. This brown bag will provide an overview and demonstration of the new eIRB Upgrade Initial Submissions Process. You will learn how the new system improves upon the current submission … Read More
Accounting of Disclosures Special Guest: Ron Marcum, M.D., M.S., CHPS Chief Privacy Officer and Information Security Officer OHSU Information Privacy and Security Office Thursday Dec. 11, 2014 11:30 a.m. to 12:30 p.m. UHS 8B60 Do you do research under a Waiver of HIPAA Authorization or a Decedents Representation? Did you know that if you send/share Protected Health Information (PHI) outside of OHSU, you need to track those disclosures in OHSU’s electronic Accounting of … Read More
We began the process of joint PVAMC/OHSU IRB review two years ago. Please join us for an update and some helpful tips on this time-saving process. Monday, Nov. 17 11:30 a.m. to 12:30 p.m. OHSU Hospital, 8th floor auditorium 8B60 Please note, this session is on Monday due to holiday scheduling
1. I need to add or remove a staff member on my eIRB study. What’s the best way to do this? You should submit staff changes independent of other changes to your study. Normally, staff-only modifications can be turned around within 24 hours, allowing your change to take effect quickly. If you pair this change with other items, the staff has to wait for the approval of the entire modification. 2. I am trying to … Read More
eIRB Upgrade Coming summer 2015! The new eIRB will help us support the rapidly growing research community at OHSU and maintain our high standards of compliance as a world-class research institution. We expect this new version will provide a much simpler, understandable and streamlined approach for submitting your studies for IRB Review. The eIRB Upgrade project has been divided into two phases: Phase 1 – Design & Phase 2 – Development and … Read More
We have recently received a few questions about the billing for industry sponsored studies. Below is a reminder of the types of modifications that are “billable” and “not billable” on these studies. As a reminder, including “no charge” or similar language in the title of your modification does not serve as a trigger for whether items are billed. If you have questions or concerns about IRB billing, please email Dave Holmgren, IRB Manager.
Join us Tuesday, July 22, 2014 11:30 a.m. to 12:30 p.m. UHS 8B60 The OHSU Institutional Review Board policies and forms web pages are getting a makeover in early July! The updated website will feature new and improved investigator resources as well as the new policies and procedures the IRB has adopted as part of its process improvement project. Attend this session to learn about: The new policies and procedures the IRB is following in reviewing … Read More
You’ve received good news that your grant to support existing research has been funded. Congratulations! Before you get started, you will need to link this new grant to the research that is currently approved by the OHSU Institutional Review Board. The IRB will help you make sure that your previously approved protocol still meets all criteria for approval as you incorporate activities of the new grant. To add your new funding to a currently approved … Read More