SiteVault Enterprise (SVE) is designed to manage the investigator site file or electronic regulatory binder. SiteVault allows for the centralized storage and use of documents such as protocols, informed consents, CVs, training certificates, and lab certifications. Paper certification and e-signature workflows are available in SiteVault. SVE is built on the Veeva Vault platform, a cloud-based, 21 CFR Part 11 compliant software package developed to help manage health authority-required records.
SVE: Access & Training
SiteVault Enterprise (SVE) is a validated system; each user requires training prior to being granted access. All users, except for outside inspectors, must obtain a PennKey. Non-Penn faculty/staff can submit an external PennKey Request Form for a guest PennKey. Access requires an Access Control Form to be completed. Note that accounts are deactivated after 6 or more months of inactivity. If you have switched job roles and/or departments, this could impact your access, and modifications to your account may be needed. Should an account be deactivated, a new Access Control Form will need to be submitted, and training completed prior to reactivation.
- Complete the SiteVault Access Control Form
- Submit the form in a ticket in the PMACS helpdesk system if you have access (select the PennVault/Veeva queue), otherwise email the form to PennVaultVeeva@helpdesk.pmacs.upenn.edu with the subject line “SVE access request”
- Penn IS will create training accounts as needed
- OCR will reach out to schedule training
- SiteVault Enterprise (SVE) Training Slides
- PennVault Training Roles (eTMF, SiteVault Enterprise) indicating what training is required for various roles
- SiteVault Enterprise (SVE) User Guide
- See Research Technology SOPs