CTRR Working Documents

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Current Working Documents

EudraCT Mapping Documents

• 2010-Jan14 Kick-off Meeting Agenda

• 2010-Jan14 Meeting Minutes

• 2010-Jan14 CTRR mapping to EudraCT Dictionary

• 2010-Jan28 CTRR mapping to EudraCT Dictionary

• 2010-Feb04 CTRR mapping to EudraCT Dictionary

• 2010-Feb10 EudraCT Dictionary mapping to BRIDG

• 2010-Feb11 EudraCT Dictionary mapping to BRIDG

• 2010-Feb16 EudraCT Dictionary mapping to BRIDG

• 2010-Feb19 EudraCT Dictionary mapping to BRIDG

• 2010-Feb24 BRIDG SCC Validation of EudraCT mapping to BRIDG

• 2010-Feb25 BRIDG SCC Validation of EudraCT mapping to BRIDG after Round 1 Comments from CTRR SubTeam

• PDF of BRIDG Model v3.0.1

• Link to BRIDG Model Website

Storyboards

CTRR Storyboards V7

Previous versions removed... .

Activity, Interaction and Trigger Events Diagrams

CTRR Activity, Interaction and Trigger Events Model - PPT

Other Documents

CTRR Enterprise Architect - EAP

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Existing Artifacts relevant to the Project

CTSA (Clinical Translational Science Award)

Informatics : Use Cases for the CTSA Human Studies Database project

CONSORT

CONSORT - Transparent Reporting of Trials Home Page

The CONSORT statement (Consolidated Standards of Reporting Trials)

A template of the CONSORT checklist

CONSORT Mapping - CDISC

WHO Minimum trial Report to ICH E3 and CDISC Protocol Representation, CDISC SDTM (in BRIDG Model)

Comparison and Rating of Clinical Trial Reporting Elements (ICH E3, CONSORT, WHO)

ClinicalTrials.gov

ClinicalTrials.gov Protocol Data Element Definitions (DRAFT) as 2/5/2009

ClinicalTrials.gov Protocol Data Element Definitions (Direct Link)

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ClinicalTrials.gov Basic Results - Data Element Definitions (DRAFT) as 2/5/2009

ClinicalTrials.gov Basic Results - Data Element Definitions (Direct Link)

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XML Schema for the results portion of clinical trial data to be uploaded into the Protocol Registration System as 2/5/2009

XML Schema for the results portion of clinical trial data to be uploaded into the Protocol Registration System (Direct Link)

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EMEA - EudraCT

EMEA - EudraCT Page

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WHO

WHO Trial Registration Data Set Version 1.0

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Protocol Representation – CDISC

Protocol Elements for Regulated Clinical Trials

PRM Mapping to BRIDG

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CDISC-HL7 Study Participation Message

Study Participation Domain Analysis Model

CDISC-HL7 Study Design Message

Study Design Analysis Model

CDISC-HL7 Study Data Message

Unavailable at this time

BRIDG Model

clinicaltrials.gov mapping document to BRIDG 2.1

CDISC ADAM

Final Release of Analysis Data Model Version 2.0