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 [email protected].
IRB Training & Educational Opportunities – Spring 2018
The Office of Research Subject Protection is pleased to offer a variety of optional training and educational opportunities during the spring 2018 semester. These trainings include both in person sessions, as well as webinars. Topics will include Introduction to the IRB (basic submission course & IRB overview), trainings about the new Revised Common Rule (Overview, Exempt Categories, Single IRB), as well as […]
Office of Research Subjects Protection – VCU Winter Closing Holiday December 21, 2017 through January 3, 2018
The Office of Research Subjects Protection will be closed for the VCU Winter Closing beginning Thursday, December 21, 2017, and will reopen on Wednesday, January 3, 2018. Despite the closing, investigators remain responsible for reporting to the IRB any unanticipated problems involving risk to subjects or others that occur during this time. In addition, as always, investigators are […]
THANKSGIVING HOLIDAY SCHEDULE
The Office of Research Subjects Protection will be closed for Thanksgiving beginning at noon on Wednesday, November 22, 2017 and will reopen on Monday, November 27, 2017. Despite the closing, investigators remain responsible for reporting to the IRB any unanticipated problems involving risk to subjects or others that occur during this time. In addition, as always, investigators are responsible for taking […]
RAMS-IRB Down Beginning 9 pm Tuesday, 8/29/17 through 12 noon Wednesday, 8/30/17
RAMS-IRB will be down beginning at 9 pm Tuesday, 8/29/17 until around 12 noonWednesday, 8/30/17 due to scheduled maintenance. Please save your work and exit the system prior to this time. Any attempted use of the system during scheduled maintenance is subject to data loss. We apologize for any inconvenience and appreciate your understanding!
Fall 2017 IRB Training
The Office of Research Subject Protection is pleased to offer a variety of educational and training opportunities during the fall 2017 semester. These trainings include Introduction to the IRB (basic submission course), trainings about the new Revised Common Rule changes coming in January 2018, regulatory trainings, as well as bringing in some guest speaker experts. […]
Regulatory Requirements for Conducting Research with Controlled Substances
Notes: Keep controlled substance records separate. Separate DEA license and separate records required for different locations. Dispensing records required for essential documents– electric or paper ok DEA Form 222: 21 CFR 1305 Regulations: www.deadiversion.usdoj.gov/21cfr/cfr/1304/1304_11.htm Reports (Theft or Loss of Controlled Substances– within 1 business day of discovery) 21 CFR 1301.74(c), 1301.76(b) — followed by DEA […]
QA/QI Toolkit
The QA/QI toolkit can be found here. Please find “Study Conduct Toolkit” at the bottom of the page.
IRB Satisfaction Survey
Dear VCU and VCU Health Faculty and Staff, The VCU Office of Research Subjects Protection invites members of the VCU research community who are familiar with the Institutional Review Board (IRB) to take a short, anonymous satisfaction survey. Your responses will help us to identify areas for improvement in the services provided by the IRB. […]
RAMS-IRB Down Tonight 11pm-10am
RAMS-IRB will be down beginning at 11pm tonight (4/6) until about 10am tomorrow morning (4/7) due to scheduled maintenance. Please save your work and exit the system prior to this time. Any attempted use of the system during scheduled maintenance is subject to data loss. We apologize for any inconvenience and appreciate your understanding!