OVPRI Human Subject Research Protection Blog

The VCU Human Research Protection Program is dedicated to facilitating ethically and scientifically sound research through robust review of research projects and through effective education and outreach to the VCU research community.

As a reminder, the RAMS-IRB system will be patched tonight (7/27/2022) from approximately 6pm – 9pm EDT. Be sure to save your work before the system goes down.

For a description of what updates are included in this patch, please refer to the summary of the changes below:

Please contact the assigned IRB coordinator for your study or ORSP@vcu.edu if problems are encountered after the patch.


A message from Lauren Kanigher, FDA Program Administrator for Investigator-initiated IND/IDEs:

The RedCap portal previously used for VCU investigator-initiated IND/IDE submissions will begin to be phased out.  Within the IRB system, you are now able to submit your IND/IDE submissions through the RAMS portal to the FDA program at VCU (this will replace the RedCap requirement but doesn’t replace the actual submission required to be submitted to the FDA).

Please direct any questions/concerns or assistance needed for this aspect of the patch for the FDA program at indide@vcu.edu.

For studies that have existing IND/IDEs (previously submitted to RedCap): You will be prompted to create an FDA page next time you go to make changes to the IRB smart form.  This new FDA page will provide you with a page to submit all future FDA submissions to VCU (instead of RedCap).  You don’t need to submit any submissions previously submitted in RedCap.

For new studies that will need an IND/IDE: you will be prompted to create an FDA page when you are completing the IRB smart form for a new study for the first time.

Categories IRB Members, News and Updates
Tagged ,