Apparatus, system and method for clinical documentation and data management

• US 20050055241A1
• Filed: 09/09/2003
• Published: 03/10/2005
• Est. Priority Date: 09/09/2003
• Status: Abandoned Application

• Current Assignee: Stephen P. Horstmann
• Original Assignee: Stephen P. Horstmann
• Inventors: Horstmann, Stephen P.
• Application Number:
  US10/658,118
• Publication Number:
  US 20050055241A1
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A system, method and apparatus for management of clinical studies to facilitate the tracking of the studies by personnel involved in the study, such as managers, coordinators, and vendors, wherever they are located, as well as placing orders, and receiving financial information, the invention being suitable for managing clinical trial documentation in connection with the pharmaceutical industry, and for facilitating communications and delivery of clinical data and documentation between clients who initiate a clinical study and a vendor who may, for example, provide data capture, data packaging, and submitting the study documentation to the appropriate authority, such as, for example, the FDA or WHO.

Claims

1. An apparatus for managing clinical studies to facilitate the tracking of the studies by personnel involved in the study, such as managers and coordinators, wherever they are located, as well as placing orders, and receiving financial information, comprising processor means for processing information, data storage means for storing data which is associated with the processor means, software for providing instructions to control the processor means, and a communications link for permitting from a location remote from the data storage means one or the other or both of access to information stored in the data storage means and retrieval of information stored on the data storage means, wherein the apparatus further comprises discrimination means for discriminating between users who have been assigned different levels of access.

2. A method for managing clinical studies to facilitate the tracking of the studies by personnel involved in the study, such as managers and coordinators, wherever they are located, as well as placing orders and receiving financial information, comprising the steps of processing with processor means for processing data stored in a data storage means for storing data which is associated with the processor means, and providing software for providing instructions to control the processor means, and exchanging information through a communications link and monitoring the status of one or more steps of a clinical study.

3. A system for managing clinical studies, comprising assigning a project management task as one of a component task and work order based task, tracking the status of the task through completion of the task, storing information about the task on a data storage device, providing access means for users to access the data stored on the data storage device to display information about the task.

4. A method for managing clinical trial studies, comprising the steps of:

providing a processor, providing software to control the processor so that a plurality of users may collaborate on the same document, collaborating on a document including reviewing and annotating the document with the user'"'"'s comments, tracking the status of the document by associating the collaboration status with the project status.

5. A method for managing clinical trial studies comprising the steps of storing information associated with clinical study documentation, providing a real-time status of clinical trial study documentation for a plurality of users accessing the information, where a change to the documentation by an authorized user is made available to one or more other authorized users, the method including maintaining the progress status for tasks relating to the clinical trial study documentation.