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Difference between revisions of "CTRR Working Documents"

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[[Category:RCRIM]]
 
Return to [[Clinical_Trials_Registration_and_Results|CTRR]] main page
 
Return to [[Clinical_Trials_Registration_and_Results|CTRR]] main page
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==Current Working Documents==
 +
 +
===EudraCT Mapping Documents===
 +
*[http://wiki.hl7.org/images/7/7c/HL7CTRR-SubTeam_14Jan2010Agenda.doc 2010-Jan14 Kick-off Meeting Agenda]
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*2010-Jan14 Meeting Minutes
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*[http://wiki.hl7.org/images/b/bb/EudraCT-CTRR_Data_Requirements_BRIDG_Mapping_2010-01-14.zip 2010-Jan14 CTRR mapping to EudraCT Dictionary]
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*[http://wiki.hl7.org/images/6/67/EudraCT-CTRR_Data_Requirements_BRIDG_Mapping_2010-01-28.zip 2010-Jan28 CTRR mapping to EudraCT Dictionary]
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*[http://wiki.hl7.org/images/f/fd/EudraCT-CTRR_Data_Requirements_BRIDG_Mapping_2010-02-04_.zip 2010-Feb04 CTRR mapping to EudraCT Dictionary]
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*[http://wiki.hl7.org/images/f/fd/EudraCT-CTRR_Data_Requirements_BRIDG_Mapping_2010-02-04_.zip 2010-Feb10 EudraCT Dictionary mapping to BRIDG]
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*[http://wiki.hl7.org/images/3/34/EudraCT-CTRR_Data_Requirements_BRIDG_Mapping_2010-02-11_.zip 2010-Feb11 EudraCT Dictionary mapping to BRIDG]
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*[http://wiki.hl7.org/images/0/09/EudraCT-CTRR_Data_Requirements_BRIDG_Mapping_2010-02-16_.zip 2010-Feb16 EudraCT Dictionary mapping to BRIDG]
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*[http://wiki.hl7.org/images/7/76/EudraCT-CTRR_Data_Requirements_BRIDG_Mapping_2010-02-19_.zip 2010-Feb19 EudraCT Dictionary mapping to BRIDG]
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*[http://wiki.hl7.org/images/b/bb/EudraCT-CTRR_Data_Requirements_BRIDG_Mapping_2010-02-24_.zip 2010-Feb24 BRIDG SCC Validation of EudraCT mapping to BRIDG]
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*[http://wiki.hl7.org/images/7/79/EudraCT-CTRR_Data_Requirements_BRIDG_Mapping_2010-02-25_.zip 2010-Feb25 BRIDG SCC Validation of EudraCT mapping to BRIDG after Round 1 Comments from CTRR SubTeam]
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*[http://wiki.hl7.org/images/b/b0/BRIDG_3.0.1_Comprehensive_Domain_Analysis_Model_pdf.zip PDF of BRIDG Model v3.0.1]
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*[http://www.bridgmodel.org/ Link to BRIDG Model Website]
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*[http://wiki.hl7.org/images/f/fd/EudraCT-CTRR_Data_Requirements_BRIDG_Mapping_2010-02-24_sds.zip BRIDG SCC Steve Sandberg Validation of EudraCT mapping to BRIDG]
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*[http://wiki.hl7.org/images/9/92/EudraCT-CTRR_Data_Requirements_BRIDG_Mapping_2010-03-17.zip BRIDG Mapping as of 2010-03-17]
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===Storyboards===
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[http://wiki.hl7.org/images/0/05/CTRR_Storyboards_v7.doc CTRR Storyboards V7]
 +
 +
Previous versions removed...
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.
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===Activity, Interaction and Trigger Events Diagrams===
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[http://wiki.hl7.org/images/c/c8/CTRR_Activity%2C_Interaction_and_Trigger_Models_V3.zip CTRR Activity, Interaction and Trigger Events Model - PPT]
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===Other Documents===
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[http://wiki.hl7.org/images/0/01/CTRR_Enterprise_Architect_file_v3.zip CTRR Enterprise Architect - EAP]
 +
 +
.
  
 
==Existing Artifacts relevant to the Project==
 
==Existing Artifacts relevant to the Project==
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===CTSA (Clinical Translational Science Award) ===
 
===CTSA (Clinical Translational Science Award) ===
  
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[http://wiki.hl7.org/images/4/48/CTSA_HSMR_Use_Cases_21Jan09.pdf]
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[http://wiki.hl7.org/images/4/48/CTSA_HSMR_Use_Cases_21Jan09.pdf Informatics : Use Cases for the CTSA Human Studies Database project]
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Informatics : Use Cases for the CTSA Human Studies Database project
 
  
  
 
===CONSORT===
 
===CONSORT===
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[http://www.consort-statement.org/ CONSORT - Transparent Reporting of Trials Home Page]
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[http://wiki.hl7.org/images/6/68/CONSORT.zip The CONSORT statement (Consolidated Standards of Reporting Trials)]
 
[http://wiki.hl7.org/images/6/68/CONSORT.zip The CONSORT statement (Consolidated Standards of Reporting Trials)]
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 +
[http://www.consort-statement.org/index.aspx?o=1315 A template of the CONSORT checklist]
  
 
===CONSORT Mapping - CDISC===
 
===CONSORT Mapping - CDISC===
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[http://wiki.hl7.org/images/d/d4/WHO-MTR-ICHE3-CDISCHL7BRIDG.doc]
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[http://wiki.hl7.org/images/d/d4/WHO-MTR-ICHE3-CDISCHL7BRIDG.doc WHO Minimum trial Report to ICH E3 and CDISC Protocol Representation, CDISC SDTM (in  BRIDG Model)]
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WHO Minimum trial Report to ICH E3 and CDISC Protocol Representation, CDISC SDTM (in  BRIDG Model)
 
  
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[http://wiki.hl7.org/images/2/20/MinTrialReport.20Nov.zip]
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[http://wiki.hl7.org/images/2/20/MinTrialReport.20Nov.zip Comparison and Rating of Clinical Trial Reporting Elements (ICH E3, CONSORT, WHO)]
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Comparison and Rating of Clinical Trial Reporting Elements (ICH E3, CONSORT, WHO)
 
  
  
 
===ClinicalTrials.gov===
 
===ClinicalTrials.gov===
  
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[http://wiki.hl7.org/images/2/24/ClinicalTrials.gov_Data_Element_Definitions_%28DRAFT%29.pdf]
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[http://wiki.hl7.org/images/2/24/ClinicalTrials.gov_Data_Element_Definitions_%28DRAFT%29.pdf ClinicalTrials.gov Protocol Data Element Definitions (DRAFT) as 2/5/2009]
  
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[http://wiki.hl7.org/images/c/c2/ClinicalTrials.gov_Basic_Results_Data_Element_Definitions_%28DRAFT%29.pdf]
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[https://register.clinicaltrials.gov/prs/html/definitions.html ClinicalTrials.gov Protocol Data Element Definitions (Direct Link)]
  
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[http://wiki.hl7.org/images/1/19/Results_xml_schema.pdf]
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-
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[http://wiki.hl7.org/images/c/c2/ClinicalTrials.gov_Basic_Results_Data_Element_Definitions_%28DRAFT%29.pdf ClinicalTrials.gov Basic Results - Data Element Definitions (DRAFT) as 2/5/2009]
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[https://register.clinicaltrials.gov/prs/html/results_definitions.html ClinicalTrials.gov Basic Results - Data Element Definitions (Direct Link)]
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-
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[http://wiki.hl7.org/images/1/19/Results_xml_schema.pdf XML Schema for the results portion of clinical trial data to be uploaded into the Protocol Registration System as 2/5/2009]
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[https://register.clinicaltrials.gov/prs/html/RRSUploadSchema.xsd XML Schema for the results portion of clinical trial data to be uploaded into the Protocol Registration System (Direct Link)]
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.
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===EMEA - EudraCT===
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[http://wiki.hl7.org/index.php?title=EMEA_-_EudraCT EMEA - EudraCT Page]
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 +
.
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===WHO===
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[http://wiki.hl7.org/images/4/4c/WHOAppendixATrialRegDataSetFeb06final-codes%284%29.doc WHO Trial Registration Data Set Version 1.0]
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 +
.
  
 
===Protocol Representation – CDISC===
 
===Protocol Representation – CDISC===
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[http://cdisc.org/standards/protocol.html Protocol Elements for Regulated Clinical Trials]
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[http://wiki.hl7.org/images/0/07/PRM-BRIDG_Mapping_15April2009.zip PRM Mapping to BRIDG]
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.
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===CDISC-HL7 Study Participation Message===
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[http://wiki.hl7.org/images/b/bb/StudyParticipationDAM.zip Study Participation Domain Analysis Model]
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===CDISC-HL7 Study Design Message===
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[http://wiki.hl7.org/images/4/48/StudyDesignDAM.zip Study Design Analysis Model]
  
−
===CDISC-HL7 Study Participation Message - Study Design Message===
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===CDISC-HL7 Study Data Message===
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Unavailable at this time
  
  
 
===BRIDG Model===
 
===BRIDG Model===
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[http://wiki.hl7.org/images/0/06/CTR_mapping_to_BRIDG_THC_results_with_INTRAchange_edits_%26_July_THC_edits_%2615_oct_edits.zip]
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[http://wiki.hl7.org/images/0/06/CTR_mapping_to_BRIDG_THC_results_with_INTRAchange_edits_%26_July_THC_edits_%2615_oct_edits.zip clinicaltrials.gov mapping document to BRIDG 2.1]
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clinicaltrials.gov mapping document to BRIDG 2.1
 
  
  
 
===CDISC ADAM===
 
===CDISC ADAM===
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[http://cdisc.org/models/adam/V2.0/index.html Final Release of Analysis Data Model Version 2.0]
  
  
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===American Immunization Registry Association (AIRA) – Pediatric messages for immunizations===
 
===American Immunization Registry Association (AIRA) – Pediatric messages for immunizations===
−
 
−
 
−
===EudraCT/EMEA===
 
−
 
−
[http://wiki.hl7.org/images/e/e6/Paediatric_Trials_Art_57_4Feb09.pdf]
 
−
 
−
[http://wiki.hl7.org/images/9/9a/Paediatric_Trials_Art_41_Public_4Feb09.pdf]
 
−
 
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===WHO===
 
−
[http://wiki.hl7.org/images/4/4c/WHOAppendixATrialRegDataSetFeb06final-codes%284%29.doc]
 
−
WHO Trial Registration Data Set Version 1.0
 
  
  
 
===Other “older” organization registries, ie, American College of Cardiology===
 
===Other “older” organization registries, ie, American College of Cardiology===

Latest revision as of 08:09, 18 March 2010

Return to CTRR main page

Current Working Documents

EudraCT Mapping Documents

  • 2010-Jan14 Meeting Minutes

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

.

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)

-

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

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

-

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)

.

EMEA - EudraCT

EMEA - EudraCT Page

.

WHO

WHO Trial Registration Data Set Version 1.0

.

Protocol Representation – CDISC

Protocol Elements for Regulated Clinical Trials

PRM Mapping to BRIDG

.

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


SAP – Statistical Analysis Plan

HL7 - Detailed Clinical Model (DCM)

EHR project

Public Health Emergency Response (PHER)

Mapping Protocol terms to MeSH

American Immunization Registry Association (AIRA) – Pediatric messages for immunizations

Other “older” organization registries, ie, American College of Cardiology

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