AQ Electronic Investigator Site File
The AQ eISF is designed with clinical trial personnel at the heart, enabling collaboration around the single source of the truth, with every edit and comment tracked and auditable it eliminates inefficiencies associated with traditional paper based systems.
A default directory is set up with the files for each clinical trial in an instant and allows the ability to share, comment and update centrally becoming a living document.
AQ eISF highlights and benefits
- Reduce regulatory compliance risks by organised, tracked and auditable documents straight from your browser
- Control and share collaborators to add comments and updates right from the AQ-eISF, centralising all comms in one place.
- Lock documents when approved with added version control
- Send workflow notifications to collaborators when critical steps completed
- User Friendly Interface
- Create a central repository of all sites and trials with enhanced personnel access
- Real time inspection ready with latest version available
Our eISF is a cloud based solution configured for electronic file sharing. The AQ eISF meets compliance with 21 CFR Part 11 requirements.
The folders have role-based access. Personal identifying information (e.g certified copies of informed consents) is maintained in folders that are only accessible by the site staff, monitors, and auditors.
The file system is configured, tested, and user roles administered by the site. Only users with specific roles and at specific sites can access an individual site’s eISF. External users , CRAs from sponsors and/or CROs can be given remote access to view and comment on documents.
The site staff can upload and download any document in their site’s folders. These documents include the site’s regulatory documents and all reference documents and training materials that have been provided to the site.
At the end of the trial, all site documents can be archived. Documents can be merged into an eTMF at the end of the study.
Why is eISF adoption the way forward?
Adopting an eISF benefits everyone involved in study conduct.
Sites win because they save hours of time (e.g., printing documents for PI signature, scanning the documents for upload to eTMF, filing paper copies, copying documents multiple times), space in their facility, and long-term storage costs.
CROs benefit because they no longer need to set up and print copies of documents for regulatory binders, so start-up is faster and more efficient.
Quality management teams can conduct audits remotely in a fraction of the time without the need to travel and from anywhere in the world.