Virtual Data Room Real-Time Clinical Trial Report Access Control
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Solution Overview
Problem
Conventional virtual data rooms lack the functionality to provide real-time clinical trial data reports and control access to users, particularly in the life science industry, where secure and timely dissemination of clinical trial information is crucial.
Innovation Solution
A virtual data room system that integrates with a clinical data management system to generate reports based on real-time clinical data, allowing controlled access to users by filtering data records based on 'cleaned' and 'locked' status, and providing different sets of reports to users with varying levels of access, ensuring only validated data is shared with authorized users.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If conventional virtual data rooms are used to store and distribute clinical trial documents, then secure and confidential access is provided through login ID and password, but the system lacks the functionality to generate and display real-time clinical trial data reports from ongoing studies
Solution Approach 1:
The patent combines the virtual data room system with clinical data management system capabilities, merging document storage and distribution functions with real-time clinical trial data report generation and display functions into a single integrated platform, thereby enhancing versatility without proportionally increasing complexity
Solution Approach 2:
The virtual data room is transformed into a multi-functional system that not only stores and distributes documents but also generates, displays, and controls access to real-time clinical trial data reports, allowing a single system to serve multiple purposes including M&A due diligence and clinical trial monitoring
2Loss of information
If all clinical trial data reports are made available to users, then complete information access is provided, but unauthorized persons may access sensitive validated data that should remain protected
Solution Approach 1:
The patent implements differential access control where different user roles (e.g., sponsors, investigators, regulators) are granted different levels of access to specific reports and data elements based on their authorization, allowing sensitive validated data to be protected while still providing appropriate information to authorized users
Solution Approach 2:
An information control administration module acts as an intermediary between the clinical data management system and users, filtering and controlling which reports are made available based on user authorization, thereby preventing direct access to sensitive data while maintaining information flow to authorized personnel
3Reliability
If the host manually controls availability of each report to users, then precise access control is achieved, but the process becomes time-consuming and operationally complex
Solution Approach 1:
The system pre-establishes access control rules and user authorization levels in advance through the information control administration module, so that when reports are generated, the appropriate access control is automatically applied without requiring manual intervention for each report-user pair
Solution Approach 2:
The information control administration module automatically manages report availability and user access based on predefined rules and user roles, eliminating the need for manual configuration and reducing operational complexity while maintaining precise access control
Data Source
AI summary
A system is provided for use in distributing information associated with an investigational product, such as a pharmaceutical drug. The information includes electronic documents associated with the investigational product, and a plurality of different electronic reports based on real-time patient clinical study data of the investigational product. The system includes a database that stores the electronic documents, a virtual data room that is in electronic communication with the database and which includes a memory that stores the electronic reports, an information presentation module, and an information control administration module. The information presentation module causes a display of the information to a user of the virtual data room via a display screen. The electronic reports are generated using the real-time patient clinical study data when requested to be displayed. The information control administration module specifies which electronic reports will be made available to the user. Only the specified electronic reports are selectable for display on the display screen by the user of the virtual data room. In this manner, only the specified electronic reports may be generated for display to a user of the virtual data room.