VCU IRB Study Closure vs Study Expiration
VCU IRB Study Closure vs Study Expiration … What is the appropriate way to end VCU IRB oversight of a research study? Appropriate Study Closure: When a study has been completed or terminated and meets the criteria for closure, a formal study closure request which provides a final status report should be promptly submitted to the IRB for […]
IRB Quality Improvement Survey
The VCU Office of Research Subjects Protection is conducting a quality improvement survey to understand how satisfied members of the VCU research community are with the Institutional Review Board (IRB). Your responses will help us to identify areas for improvement in the services provided by the IRB. This survey should take less than 10 minutes […]
New CITI BioSafety Course – NOT Required, but Available
CITI’s BioSafety Course is now available, however is NOT required through the Office of Research Subject Protection. It is an optional course unless the lab’s Principal Investigator (PI) assigns it. If you have specific questions about the course, please contact the Biosafety Officer at 804-400-4984. Please refer to this link for directions on how to add a CITI […]
FIR Annual Updates due by July 1st in VCU AIRS
The Activity and Interest Reporting System (AIRS) is available for the annual update of Financial Interest Reports (FIR) beginning on May 10th, 2016. The annual update is due by July 1st for all PIs and COI investigators on active or pending proposals or protocols. As per policy, FIRs are assessed by the COI Program for financial conflicts of interest related to specific research projects. Protocol approval and/or […]
IRB Procedures for PI Separation
If you are a PI on a study and have plans to leave VCU in the near future, please ensure that you have taken the proper steps regarding your IRB studies prior to your separation from the institution. If a study is to remain open, please submit an amendment in RAMS-IRB to change the PI […]
New Two-Factor Authentication for VCU VPN
Beginning May 5th, VCU Technology Services is mandating the use of two-factor authentication for the RAMS VPN. This will be required for off-campus use of any of the Office of Research RAMS systems (ACUP, AIRS, IRB, SPOT, VITALS, CORES, InfoEd, Reports). The Office of Research Information Systems team has prepared a guide document (below) illustrating how to […]
Reminder: Stacking Documents
Reminder: Stacking Documents Anytime you make a revision to your documents (pre-screen or review process – initial or amendment), it is important that you stack those documents. This helps the IRB manage multiple versions of documents, usually associated with revisions (ex. consent form – original, red-line, updated (clean copy), etc.). Refer to the following […]
Registries in Research
Below is the Registries in Research training presentation for your reference! Registries in Research
IRB CITI Training Clarification
IRB CITI Training Clarification The Office of Research Subjects Protections requires all investigators and those involved in human subject research to complete CITI training. CITI Initial Training: CITI BASIC Human Subjects Protection Training Bio-Medical OR Social Behavioral Note: CITI’s Responsible Conduct of Research (RCR) or Good Clinical Practice (GCP) courses does not meet the IRB’s requirement; please ensure […]
IRB Member 5th Thursday Training Materials
Below are the presentation materials for each of the 5th Thursday IRB Member training. RAMS-IRB Training Worksheet IRB Member Regulatory Training – HIPAA/FDA Conducting Reviews Systematically and Efficiently We sincerely thank all the members who took the time to come and participate, and for those of you who could not make it, we hope you find […]