Genius Site Vault solves the administrative, regulatory and privacy compliance challenges and improves efficiency and quality, since this this cloud-based solution is owned and managed by the site staff who allows monitor to get access for a reliable and timely rSDV.
Purpose-built source document system. Connected with the study eCRF and Exom Virtual Assistant (EVA) allows sites to easily comply with the required verification of source documents , maintain visibility over the flow of data and documents, and improve overall data quality.
It tracks the detailed, back and forth query communications between a study site and monitor when reviewing source documents.
Upon review of certified electronic copies of the source documents, monitor can generate in the eCRF the relevant queries that are automatically notified to the investigator through the Virtual Assistant (EVA) and then writes the appropriate visit report.
The source documents are organized by patient’s code and flagged by verification status:
- reviewed with queries pending
- reviewed with queries solved
- reviewed without issues
- not yet reviewed
- no review required
A special flag identifies those documents that require an expedite review process by monitor such an SAE narrative or a protocol deviation.
Real-time metrics on documents upload date, review date, queries generated and turnaround times by patients and visits are also available.
Since the workspace is fully encrypted, owned and managed by the site, the uploaded source documents can be stored in Genius Site Vault up to the study end and no prior approval is required by the hospital DPO (Data Protection Officer) where present.
The ability to view historical revised document and generated actions can help reconstruct the story of a trial and onboard new study team members will occur more quickly and smoothly.
The site monitor is only allowed to see the documents and not downloading or printing them.
Genius Site Vault: Technical Specifications
- Documents will be uploaded and stored encrypted through client-side encryption, with encryption key totally under control of the site.
- No one, including Exom IT system admin, can access or decrypt documents on behalf of the site personnel.
- The authentication, authorization and access to the service will be granted with Single Sign On technology through Azure Active Directory, with the same account used for other Study related services (portal, eCRF, eIC, eTMF, etc.)
- Encryption is granted in transit (with https connection), at rest (storage) and in backups
- The service is run by Exom in the AWS cloud, inside a fully GxP compliant infrastructure
- The storage layer is managed with AWS S3, to have a secure, durable, redundant and available storage
- All transactions are encrypted with audit trail of changes
- Validated according to 21 CRF part 11
Fully GDPR and HIPPA compliant. No risk of data privacy breach since all patient’s clinical data remain within the control of the investigative site.