E-ISF & PSF

AQ E-ISF & PSF (Electronic Investigator Site File) is a cloud-based document management solution from AQ-Trials designed for clinical trial sites and research teams. It replaces paper-based investigator site file systems with a centralised digital repository, aiming to reduce administrative burden, improve regulatory compliance, and support collaboration across trial personnel, sponsors, and external governing bodies.

The platform covers both the electronic Investigator Site File (eISF) and the Participant/Patient Site File (PSF), and is built to support inspection readiness, document lifecycle control, and audit transparency without the high costs associated with comparable systems.

Collaboration Features

• Supports multiple simultaneous users accessing and working within the same repository.
• Cloud-based architecture allows access from any location with an internet connection.
• Teams can be invited to collaborate and share data within the platform.
• External parties, such as Clinical Research Associates (CRAs) from sponsors, can be granted access for external collaboration.
• Custom time limits can be set to control how long external or internal users retain data access.
• Collaborators can add comments and updates directly within the repository.
• All communications are centralised in one place to reduce confusion and improve coordination.

Compliance Automation and Workflow Management

• Documents are organised, tracked, and auditable directly from a browser, reducing regulatory compliance risks.
• Workflow notifications are sent to collaborators when critical steps in a process are completed.
• Users are assigned actions within workflows, reducing the risk of missed tasks or steps.

Document Management and Storage

• Provides a central repository with folder structures for all sites and trials, with role-based access controls.
• Supports upload of key documents to folders with unlimited storage capacity and security measures.
• Functions as a general document management system, reducing reliance on paper-based records.
• Improves organisation and accessibility of important trial documents.
• Sensitive documents are protected with enhanced access controls.

Document Lifecycle and Version Control

• Ensures the latest version of any document is always available and ready for regulatory inspection.
• Approved documents can be locked with version control applied, preventing unauthorised changes to finalised files.
• All documents are archived and can be retrieved when required.
• Redundant and duplicate documents can be eliminated to reduce clutter.
• A clear history of document modifications is maintained through version tracking.

Access Control, Auditing, and Regulatory Compliance

• Supports compliance with 21 CFR Part 11 for secure electronic record keeping.
• Integrates with global regulatory requirements for archiving and electronic Trial Master File (eTMF) standards.
• Flexible role-based access control allows administrators to customise user permissions at the folder and document level.
• Advanced auditing capabilities include the ability to view and download detailed audit logs for transparency and accountability.