New CITI Course on the Revised Common Rule
Learn More about the 2018 Common Rule The 2018 Common Rule represents the first major change in the Federal Policy for the Protection of Human Research Subjects since its implementation. As we’re preparing resources to address the revisions in RAMS-IRB and elsewhere, we’ve added a new optional course in CITI for researchers who are interested […]
VCU ORSP Winter Closing Holiday Schedule 2018
Office of Research Subjects Protection The Office of Research Subjects Protection will be closed for the VCU Winter Closing Friday, 12/21/18 through Tuesday, 1/1/19, and will reopen on Wednesday, 1/2/19. Please Note: Investigators remain responsible for reporting to the IRB any unanticipated problems involving risk to subjects or others that occur during this time. In addition, […]
Full Board IRB Meeting Twice as Often for December Submissions
In anticipation of increased submissions in December, the full board IRB is doubling its upcoming meeting schedule. Instead of one meeting, there will be two meetings held on each of the following dates: Wednesday, December 12th Wednesday, December 19th Wednesday, January 9th We hope the increase in meetings will allow for the IRB to better […]
Important Changes to the Common Rule
On January 21, 2019, revisions to the Federal Policy for the Protection of Human Subjects will go into effect. This new version of the “Common Rule,” as it is typically known, represents the first revision to the rule since its publication in 1991. Many of us in the world of Human Subjects Protection have been […]
Important RAMS-IRB Patch and Holiday Schedule Announcement
Upcoming RAMS-IRB Patch – RAMS-IRB will be down 11/15/18, 9:00 pm through 11/16/18, 1:00 pm while this update is being installed. This update includes new/revised questions within the smartform. Protocols submitted following the update will require responses to applicable new questions. If responses remain outstanding at submission, investigators may encounter an error message. You can identify and view […]
Continuing Review and Closure Forms REQUIRED for Relying Sites
Please note, all non-VCU sites that rely on VCU for IRB review will be required to submit a continuing review progress report at the time of continuing review. The effective dates for this requirement are below: Beginning on November 1st, all expedited studies will be required to submit a continuing review progress report at the […]
Records Management Updates
The Records Management Office is excited to announce these summer updates: New Training Modules – The self-paced Records Management 101 course has been revamped. Each training module is 5 minutes or less and can be revisited outside of the Blackboard course if a quick refresher is needed at anytime: Course Registration [keyword: “records”]: https://training.vcu.edu/offering Refresher Material: https://vcu.mediaspace.kaltura.com/channel/Records%2BManagement/95117531 Online RM-3 […]
Important RAMS-IRB Patch Announcement
An update to the RAMS-IRB system is tentatively scheduled to occur between 7/23/2018 and 8/3/2018. Two of the items in this system patch will affect investigators: PI Action reminders will be sent to investigators and study editors every 3 days instead of every 30 days. What are PI Action reminders? PI Action reminders are automatically […]
Single IRB Fees
Single IRB Fees The single IRB (sIRB) mandate is a set of harmonizing federal policies that require certain types of federally-funded studies that involve multiple institutions/sites to use a single IRB to accomplish IRB review and approval for all of the institutions. This information may also be useful for multi-site studies that are not federally-funded […]
Updated PAMQuIP Toolkit Resources Available
Please note that the link to the Study Conduct Toolkit has been updated. In addition, 41 adaptable templates have been updated and there are 3 new consent tracking documents. Please take a look at these valuable resources, and consider using them in your studies. The templates are helpful for organizing studies, study conduct under GCP, […]