Veeva SiteVault is a cloud solution that provides research sites with a fully compliant eReg application to further support compliance with FDA, 21 CFR Part 11, and HIPAA regulations. Standard features include electronic regulatory binder, remote monitoring, and electronic signatures.
If using Veeva SiteVault for subject data monitoring purposes, Protected Health Information (PHI)I must be redacted from source documents before upload. However, if PHI is required by the Sponsor to be uploaded to Veeva SiteVault (for example, if the Sponsor is using the product for all of their study sites), the study team must ensure there is appropriate indemnification language in the clinical trial agreement in case of accidental breach.
