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Office of Research Oversight

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Site Visit Preparation

Knowing what to expect from an ORO program review can make the process go smoother and relieve the stress that is sometimes associated with a site visit.  Timelines may vary depending on the type of review so always check with the ORO team conducting your program review for up-to-date information.
 
• Preparation
o ORO contacts facility approximately 10-12 weeks prior to review; negotiate visit schedule, discuss agenda
o ORO sends formal Letter of Notification 6-8 weeks prior to on-site review; agenda, logistics, document request
o Facility document upload to ORO secure SharePoint site approximately 2-4 weeks prior to review; includes such documents as protocol list, policies and procedures, RDC/IRB documents, and other documents as specified by the team conducting the site visit
o Complete checklist(s) associated with the type(s) of program review  (http://www.va.gov/ORO/orochecklists.asp)
o Provide select protocol documents (if electronic)

• Typical Agenda
o Entrance briefing with Medical Center Management
o Scheduled interviews of Facility Director, Chief of Staff, and affected staff such as the ACOS/AO, RCO, ISO/PO, Committee chairs/members, and PIs
o Walk-through of research areas
o Document and protocol review
o Follow-up interviews
o Research Service and Medical Center Management exit briefings

• Report
o ORO sends the draft report to the facility for fact-check sent 4-6 weeks after on-site review; the final report is sent 6-10 weeks after on-site review
o Sections:  Background, Network arrangements (for Research Information Security Program reviews), Strengths, Findings (Reference, Noncompliance, Required Action), Observations, Conclusion, Appendices, Required Action Plan Template
o Goes to Medical Center Director, VISN, USH

• Follow-up Required Action Plan (RAP)
o Required Action (RA) for each Finding; responsibilities for remediation will vary depending on the issue
o Protocol-specific noncompliance to be remediated within 120 days
o Programmatic noncompliance to be remediated within 180 days
o ORO works with facility to ensure RAPs including timelines are appropriate
o Status update approximately once per month
o Case closure upon completion of all RAs


ORO also conducts Technical Assistance Reviews to provide general assistance or to address the specific needs of a facility.  These 1-2 day reviews are different than program reviews.

• Technical Assistance reviews
o Can be Remote (using Vtel) and/or On-site
o Can be done at the facility’s request
o Can be one-time or recurring over several weeks
o Agenda is based on the needs of the facility
o No Findings/Required Actions