Veeva products - Research and Innovation - Virginia Commonwealth University

Spend more of your time doing research and less time filing papers.

As VCU clinical research has grown, we remain focused on improving the quality of health in our community, our region, and across the globe. This means a higher demand to spend more time doing impactful research and less time filing papers in space-consuming paper binders.

VCU-Veeva, our new 21 CFR Part 11 compliant system, supports superior quality management for single and multi-site clinical research studies and trials. VCU-Veeva is fully approved for remote single-sign-on, making collaboration across any of the 287 VCU Health Clinical Sites a breeze (via Site Vault) and VCU-led multi-site clinical trials (via eTMF) feasible and practical.

Specifically, VCU-Veeva is designed to benefit research teams through:

Improve efficiency
Remote access to records
Reduced operating cost
Reduced study start-up
Routine electronic monitoring
Improved transparency
Better team onboarding
Easy and independent compliance checks

Veeva SiteVault

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.

VCU has an institutional requirement of the use of Veeva SiteVault in accordance with compliance notice 23-002: Institutional requirement to use Veeva SiteVault for clinical trials.

Veeva SiteVault guidance documents and guidelines:

SiteVault: Use of an electronic investigator site file
SiteVault: Use of certified copy
SiteVault: Use of electronic signatures
SiteVault: Use of electronic delegation of authority
SiteVault: User account management and training for the electronic investigator site file
SiteVault: Monitoring and source documentation
SiteVault: Veeva eConsent
SiteVault: Study life cycles
SiteVault: Remote monitoring tracking template
A tool to assist study teams in tracking monitoring visits
SiteVault: Study source plan development template
A tool to assist study teams in communicating with sponsors how source documentation is generated
SiteVault: Recommended SiteVault training videos
SiteVault: Help center
Includes additional training resources and frequently asked questions
SiteVault: User quick reference guide
SiteVault: Document types reference spreadsheet
A tool to assist in the available document types, required fields, lifecycles of documents and whether monitors can view or download the document

Existing studies and sponsor resources:

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 includes industry or government sponsored research where the industry or government is only providing funding or investigational product(s). This excludes industry or government sponsored-run research that is multi-site where industry or the government is acting as the regulatory sponsor or single-site investigator-initiated clinical trials. All multi-site clinical trials that fit the specified criteria are required to utilize Veeva eTMF.

VCU has an institutional requirement of the use of Veeva eTMF in accordance with compliance notice 23-001: Institutional requirement to use Veeva eTMF for multi-center clinical trials where VCU is the coordinating site.

Veeva eTMF (trial master file) guidance documents and guidelines:

eTMF: Trial master file setup and planning
eTMF: Document collection and processing
eTMF: Oversight and inspection readiness
eTMF: Closeout and archival
eTMF: Certified copy
eTMF: Records retention
eTMF: Template plan
A tool to help study teams set up their eTMF
eTMF: Study roles
eTMF: Good vault practices
How to steps on how to do basic functions in eTMF
eTMF: Vault emails

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.

Veeva EDC

Veeva EDC is a 21 CFR part 11 compliant electronic data capture (EDC) designed for clinical trials. This system will only be used at VCU for studies where the study is investigator-initiated or VCU is running the study (acting as the coordinating center) and the study must follow FDA regulations (ex: studies where VCU holds the IND/IDE). This includes industry or government sponsored research where the sponsor is only providing funding or investigational product(s).

Veeva EDC guidance documents and guidelines:

Veeva EDC: User account management
Veeva EDC: Study build best practices
Veeva EDC: Data management
Veeva EDC: Data entry and signatures
Veeva EDC: Study closeout and archival
Veeva EDC: Records retention
Veeva EDC: Veeva clinical data help center
Includes additional training resources
Veeva EDC: Tutorial videos

Veeva EDC system access:

Veeva EDC is going live this fall at VCU.

VCU-Veeva monthly office hours now available

Have questions about either of the 21 CFR Part 11 compliant Veeva systems VCU has? Join OVPRI Veeva superusers on the third Monday of each month at noon to learn more about the system, how to gain access, and any other questions you may have.

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