Regulatory Affairs

Office of the Vice President and Innovation

Category results for: Policies & Guidance

VCU Health Policy Update

MR.PH.002 – Protected Health Information Release has recently been updated to provide more clarity in Procedure 8: Granting Request.  Please find a copy of the new policy here: as well as on the VCU Health systems.

VCUH Notice: Clinical Research Billing

As most of you know, VCUH has recently implemented Patient Protocol Manager (PPM) to facilitate clinical research billing compliance.  We would like to thank you for your assistance in making this project a success.  However, during the implementation, we have identified a pattern where, in a significant number of cases, there is no documentation in […]

VCU Health Policy Updates

Please use this link to access the following updated VCU Health policies impacting clinical research since January 2019: Infection Control: Hand Hygiene Policy (IC.CL.002) v.4/3/2019 Medical Records: Documentation – Entries in the Medical Record (MR.RC.001) v.2/1/2019

Updated Resource for Investigators and Sponsors of Investigational Drugs at VCU

The VCU Health Investigational Drug Service has updated their website with new guidance and policies for research teams as well as for sponsors/monitors. Please visit their page for more information:

ORCID IDs Protect Researcher Identities and Time

The Open Researcher and Contributor ID (ORCID) helps you build and maintain your reputation and career. ORCID helps you easily and reliably link your unique identity with your contributions such as datasets, articles, books, media stories, samples, experiments, patents and notebooks. ORCID is increasingly being used by funding agency and publisher computer systems to identify […]

Uploading Clinical Trial Informed Consent Documents into Cerner

In follow-up to VCU Health notice issued on January 4, 2019 regarding uploading clinical trial consents into Cerner, this is a reminder of the established options available to transition signed consents into the patient medical record and one new option: 1.       You can create a pdf of the signed ICF and email it to […]

New Navigational Resource

Find resources for your research more easily and get help finding what you need, when you need it. The Wright Center Research Navigation Page is available to connect researchers to the resources they need to conduct their research. The Wright Center assists researchers at all stages of the process and at any point in their […]

Updated ClinRegs Website

NIH recently updated the international clinical research regulations registry.  The National Institute of Allergy and Infectious Diseases (NIAID)’s ClinRegs website is an online database of country-specific, clinical research regulatory information. By providing well-documented and current information in a single place, ClinRegs serves as a central resource and time-saver for persons involved in planning and implementing […]

VCU Health Requirement: Signed Informed Consent Documents in Cerner

Storage of the signed clinical research ICF in Cerner is good research practice and a Joint Commission requirement.  VCU Health understands that many research team professionals do not have the required access or necessary resources to fulfill this requirement. To that end, the CRU is pleased to offer assistance in the process. Following are the […]

Nov. 21: Comments due on draft revision to Standard Rates for Ancillary/Inpatient Clinical Research Services (14-001)

Please note that the following research compliance notice pertaining specifically to clinical research has been prepared for public comment due to substantive edits: Notice 14-001.2 Standard Rates for Ancillary and Inpatient Clinical Research Services.docx Your comments, questions, and suggestions are welcome (send to  The formal VCU research community comment period ends November 21, 2018. […]

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