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:
- Use of an electronic investigator site file
- Use of certified copy
- Use of electronic signatures
- Use of electronic delegation of authority
- User account management and training for the electronic investigator site file
- Monitoring and source documentation
- Study life cycles in Veeva SiteVault
- Remote monitoring tracking template : A tool to assist study teams in tracking monitoring visits
- Study source plan development template: A tool to assist study teams in communicating with sponsors how source documentation is generated
- Recommended SiteVault training videos
- SiteVault help center: Includes additional training resources and frequently asked questions
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 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:
- Trial master file setup and planning
- Document collection and processing
- TMF oversight and inspection readiness
- TMF closeout and archival
- TMF certified copy
- Records retention
- Template TMF plan: A tool to help study teams set up their eTMF
- eTMF study roles
- Good vault practices: How to steps on how to do basic functions in eTMF
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.
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