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Veeva products

VCU has procured Veeva products for VCU researchers to use to assist in electronic regulatory records and to aid in improving the quality and efficiency of the research conducted at VCU.

Veeva SiteVault (Coming March 13, 2023)

Veeva SiteVault is a 21 CFR part 11 compliant electronic regulatory system designed for clinical trials. This system has the ability to facilitate obtaining electronic signatures related to these clinical trials and allows for remote external monitoring. This system will be available to all researchers and their study teams at VCU regardless of the sponsor of the study. It is intended to replace paper binders. Source documentation initially created in EPIC should remain in EPIC and should not be put into this system. 

Veeva SiteVault guidance documents and guidelines:

Veeva SiteVault system access:

Veeva SiteVault access will be granted upon request for VCU internal after the completion of the required Veeva SiteVault training

Site Administrators within the Veeva SiteVault system have the ability to create external user accounts (ex: monitors, auditors or inspectors).

Veeva eTMF 

Veeva eTMF is a 21 CFR part 11 compliant electronic regulatory system designed for multi-site clinical trials. This system will only be used at VCU for studies where VCU is acting as the coordinating center and/or sponsor and there are (or there are intended to be) external sites. This excludes industry or government sponsored-run research that is multi-site or single-site investigator-initiated clinical trials. All multi-site clinical trials that fit the specified criteria are required to utilize Veeva eTMF.

Veeva eTMF guidance documents and guidelines: 

Veeva eTMF system access:

Veeva eTMF access will be granted upon request after the completion of the required Veeva eTMF training.

To obtain access to Veeva eTMF for an external user (external monitors/auditors/inspectors such as for the purpose of a FDA inspection), please contact Lauren Wallace and Jim Ward directly.

Contact us

For any questions related to either Veeva product:

Lauren Wallace, MS, RAC-Drugs
Director of clinical research regulatory affairs

Jim Ward, MS, MBA
Assistant vice president of research computing