WO1999063473A3 - Clinical trial data management system and method - Google Patents

Clinical trial data management system and method Download PDF

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Publication number
WO1999063473A3
WO1999063473A3 PCT/US1999/012406 US9912406W WO9963473A3 WO 1999063473 A3 WO1999063473 A3 WO 1999063473A3 US 9912406 W US9912406 W US 9912406W WO 9963473 A3 WO9963473 A3 WO 9963473A3
Authority
WO
WIPO (PCT)
Prior art keywords
protocol
trial
client
information
generated
Prior art date
Application number
PCT/US1999/012406
Other languages
French (fr)
Other versions
WO1999063473A2 (en
Inventor
Paul A Bleicher
Nicholas Stamos
Jeffrey P Klofft
Richard M Dale
Original Assignee
Phase Forward Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Phase Forward Inc filed Critical Phase Forward Inc
Priority to AT99927196T priority Critical patent/ATE227448T1/en
Priority to DE69903808T priority patent/DE69903808T2/en
Priority to EP99927196A priority patent/EP1082693B1/en
Publication of WO1999063473A2 publication Critical patent/WO1999063473A2/en
Publication of WO1999063473A3 publication Critical patent/WO1999063473A3/en

Links

Classifications

    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H70/00—ICT specially adapted for the handling or processing of medical references
    • G16H70/40—ICT specially adapted for the handling or processing of medical references relating to drugs, e.g. their side effects or intended usage

Abstract

A system and method for managing clinical trial data includes dynamically generating, at a server, a data entry form to be displayed at a client. The data entry form is generated dynamically in a SGML-derived language. Control elements within the form comprise images which are used to construct the control elements and larger controls. The form is generated from a protocol database and a context received from the client, is populated from the data database, and is published to the client. Templates based on the protocol database comprise several frames including intermediate frames for displaying frame borders which are non-horizontal and non-vertical. If the trial protocol changes during a trial, the generated form is based on the protocol version active at the time data was entered into the form. Inadvertent use of the application is discouraged requiring an authentication procedure and displaying a picture of the authenticated user. Furthermore, help is provided by creating a link between the text of each question and information about the question. The source of help may be any or all of a protocol document, an investigative brochure, and a study guide. In addition, a user, upon logging in, is presented with a dashboard screen which provides information or links to information such as trial-related news, alerts, statistical information, progress reports and a list of work to be completed.
PCT/US1999/012406 1998-06-05 1999-06-03 Clinical trial data management system and method WO1999063473A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
AT99927196T ATE227448T1 (en) 1998-06-05 1999-06-03 DATA MANAGEMENT SYSTEM AND METHODS FOR CLINICAL TRIALS
DE69903808T DE69903808T2 (en) 1998-06-05 1999-06-03 DATA MANAGEMENT SYSTEM AND METHOD FOR CLINICAL STUDIES
EP99927196A EP1082693B1 (en) 1998-06-05 1999-06-03 Clinical trial data management system and method

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/092,441 1998-06-05
US09/092,441 US6820235B1 (en) 1998-06-05 1998-06-05 Clinical trial data management system and method

Publications (2)

Publication Number Publication Date
WO1999063473A2 WO1999063473A2 (en) 1999-12-09
WO1999063473A3 true WO1999063473A3 (en) 2000-01-27

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1999/012406 WO1999063473A2 (en) 1998-06-05 1999-06-03 Clinical trial data management system and method

Country Status (6)

Country Link
US (2) US6820235B1 (en)
EP (1) EP1082693B1 (en)
AT (1) ATE227448T1 (en)
DE (1) DE69903808T2 (en)
ES (1) ES2318896T3 (en)
WO (1) WO1999063473A2 (en)

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EP1082693B1 (en) 2002-11-06
ATE227448T1 (en) 2002-11-15
WO1999063473A2 (en) 1999-12-09
US20050149852A1 (en) 2005-07-07
EP1082693A2 (en) 2001-03-14
ES2318896T3 (en) 2009-05-21
DE69903808T2 (en) 2003-09-11
US6820235B1 (en) 2004-11-16

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