User Settings - Mobile Web Client

This video provides a practical, step-by-step guide on navigating and customizing user settings within the mobile web client of a specialized clinical or regulatory document management system, likely an electronic Trial Master File (eTMF) or e-regulatory platform such as SureClinical. The primary purpose is to empower users—who are typically clinical research associates, study coordinators, or regulatory personnel—to tailor their interface, manage their digital identity, and optimize document viewing preferences for efficient mobile workflow. The presentation focuses on three main areas: user account security, profile management related to clinical studies, and specific settings for document tree visualization and electronic signature appearance.

The initial segment details critical security and identity management functions available under the "User Account Settings." This section emphasizes the user's control over their digital credentials, which is paramount in regulated environments like pharmaceuticals. Users are shown how to change their password and PIN code, essential practices for maintaining data security and adherence to regulatory requirements like 21 CFR Part 11 for electronic records and signatures. Furthermore, the ability to revoke a digital ID and email the administrator for support highlights built-in compliance and support mechanisms necessary for audit trails and system integrity. The focus on notification preferences also ensures that users can stay current on critical document updates or required actions, minimizing delays in regulated workflows.

The subsequent sections delve into operational efficiency within a clinical context. The "User Profile" settings allow personnel who work across multiple trials to seamlessly switch between studies, enabling them to view either all active studies or focus on a single study at a time. This functionality is crucial for maintaining focus and preventing errors in multi-study environments. Most importantly, the "Document Tree Settings" provide granular control over how regulated documents are organized and displayed. Users can select various viewing hierarchies, such as grouping documents by person, person role, organization, organization role, study site, or the highly specific combination of study subject and visit number. This flexibility is vital for clinical monitoring and data review, allowing users to quickly locate documentation based on the specific context of the clinical trial.

Finally, the video addresses workflow management and regulatory appearance standards. The system offers filtering capabilities that allow users to quickly isolate documents based on their current status in the workflow—such as "in review," "quality items," "unsigned documents," "signed documents," or "my documents." This feature streamlines quality control and compliance checks. The demonstration concludes with the "Digital ID Appearance" section, allowing users to customize the visual style of their electronic signature. While the underlying legal validity remains constant, customizing the appearance helps users quickly identify their own signatures and ensures organizational consistency, before finally showing the standard sign-out procedure.

Key Takeaways: • Digital Identity and Security Management: Users have direct control over core security credentials, including the ability to change passwords and PIN codes, which is foundational for maintaining the integrity and non-repudiation required by regulatory standards like 21 CFR Part 11. • Electronic Signature Compliance: The system explicitly supports managing the digital ID, including the ability to revoke it and customize its appearance, underscoring the importance of compliant electronic signatures in GxP documentation workflows. • Optimized Multi-Study Workflow: Clinical personnel can efficiently manage their workload by utilizing the user profile settings to switch between viewing all studies or focusing on a single study, preventing context switching errors and enhancing productivity. • Granular Document Organization: The platform offers highly flexible document tree settings, allowing users to organize documents based on clinical context (e.g., study subject and visit number) or organizational structure (e.g., person role, study site). This is essential for effective eTMF management and audit preparation. • Workflow Status Filtering: Users can leverage filtering options to quickly isolate documents based on their status (e.g., unsigned, in review, quality items). This feature is critical for accelerating quality assurance processes and ensuring timely completion of required signatures. • Role-Based Document Viewing: The option to view documents organized by "person role" or "organization role" facilitates compliance checks, ensuring that documents are accessible and reviewed by the appropriate authorized personnel within the clinical hierarchy. • Mobile Client Focus: The entire demonstration is centered on the mobile web client, highlighting the necessity for regulated systems to provide full functionality and compliance features (like digital ID management) on mobile devices for field-based clinical operations staff. • Proactive Support Access: The inclusion of an option to "email your administrator for support" directly within the user account settings ensures that users can rapidly address technical or security issues related to their digital ID or access. • Notification Customization: Users can set preferences for notifications, allowing them to tailor alerts for document updates or required actions, which helps prevent bottlenecks in time-sensitive regulatory and clinical workflows.

Tools/Resources Mentioned:

• SureClinical (Implied Platform)
• Mobile Web Client (Interface)

Key Concepts:

• Digital ID: An electronic credential used to verify a user's identity and apply legally binding electronic signatures, often required under 21 CFR Part 11.
• PIN Code: A secondary security measure used to protect the digital ID, often required before applying an electronic signature.
• Document Tree Settings: Configuration options that determine the hierarchical structure and grouping of documents within a regulated system, crucial for organizing clinical data (eTMF).
• Electronic Signature Appearance: The customizable visual representation of the digital ID when applied to a document, which must meet specific organizational and regulatory standards.