System and method for electronic document management, organization, collaboration, and submission in clinical trials
OwnerJules T. Mitchel, Joyce B. Haysinventors
Life of this patent
Estimating the term…
Abstract
According to the present invention, there is provided a system and method for the management, organization, collaboration, and submission of electronic files and documents associated with a clinical trial. The system of the present invention enables users to create and easily access a central document repository. The system of the present invention includes various tools for the management, organization, collaboration, and editing of the documents and files stored within the system, as well as tools which enable automated regulatory submissions of required documents and files.
Claims14
An integrated clinical trial document management system comprising:
- document management means for generating and modifying electronic documents, organization means for creating and implementing an organizational structure, storage means for storing and archiving documents and files, tracking means for maintaining an audit trail of system events, security means for maintaining data integrity, communication means for enabling electronic communication and collaboration, notification means for implementing electronic notifications and alerts, administration means for modifying the system's operation, and submission means for submitting documents to regulatory agencies.
A clinical trial document management method comprising the steps of:
- generating and modifying electronic documents, creating and implementing an organizational structure, storing and archiving documents and files, maintaining an audit trail of system events, maintaining data integrity, enabling electronic communication and collaboration, implementing electronic notifications and alerts, modifying the system's operation, and submitting documents to regulatory agencies.
Dependencies are inferred from the claim text.