RAMS-IRB Update is Complete
RAMS-IRB was updated on January 30th. Thanks for your patience as we’ve worked to complete the updates. Here’s what you need to know: New studies that were in a state of “PI Action” before the patch have reverted to IRB staff statuses in order to map IRB Comments to the appropriate sections of the revised […]
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, […]
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, […]
Building Inclusive Communities – Development Opportunity
Building Inclusive Communities (BIC) is a professional and personal development initiative designed to provide foundational cultural competence education for members of the VCU community. BIC is offered through 1-day or 2-day workshops, is aligned with VCU’s diversity and inclusion strategic plan, and has been supported through the Division for Inclusive Excellence. Researchers at VCU are […]
Registration NOW OPEN for VCU’s 3rd annual Quality in Clinical Research Conference- April 13th
3rd Annual Quality in Clinical Research Day April 13, 2018 8 am – 4 pm VCU Larrick Student Center With special guest speaker: Courtney N. Long (BIMO Specialist) This FDA inspector will speak on the Bioresearch Monitoring Program (BIMO) process and what the FDA is really looking for during inspections. Join us! Register HERE: go.vcu.edu/april13 For questions, please contact us at indide@vcuhealth.org.