The VCU HRPP would like to share this message from Mary Harmon, regarding clarifications surrounding the process to obtain data from VCUHS EMRs.
Please direct questions regarding this process to Mary Harmon.
VCUHS and VCU would like to take this opportunity to provide clarity to recent changes and communication regarding the approved pathways to request/obtain data from the VCUHS EMR. These pathways have been vetted and align our data access options with HIPAA regulations, etc.
Screening for Eligibility
Cohort Discovery or Secondary Data Review
o Cohort discovery
o Discrete data with an IRB and Privacy Board approval
o Manual chart review support for any approved data elements not available through a discrete data pull by providing a patient list for the study cohort and setting up data collection forms within Redcap
o Study participant recruitment support (e.g., identifying potentially eligible patients before they arrive for a scheduled clinic visit)
o De-identified data
o Limited Data Sets with a completed Data Use Agreement
We will be discussing this issue at our next Clinical Research Teams Meeting for which a meeting invite will be sent next week. In the meantime, should you have any questions, please do not hesitate to reach out to me.
Mary P. Harmon, PhD
Director of Clinical Research
Virginia Commonwealth University Health System
1300 E. Marshall Street
P.O. Box 981055
Richmond, Virginia 23298-0155