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Return to [[Clinical_Trials_Registration_and_Results|CTRR]] main page | Return to [[Clinical_Trials_Registration_and_Results|CTRR]] main page | ||
==Current Working Documents== | ==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] | ||
| + | |||
| + | *[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] | ||
| + | |||
| + | *[http://wiki.hl7.org/images/f/fd/EudraCT-CTRR_Data_Requirements_BRIDG_Mapping_2010-02-04_.zip 2010-Feb10 EudraCT Dictionary mapping to BRIDG] | ||
| + | |||
| + | *[http://wiki.hl7.org/images/3/34/EudraCT-CTRR_Data_Requirements_BRIDG_Mapping_2010-02-11_.zip 2010-Feb11 EudraCT Dictionary mapping to BRIDG] | ||
| + | |||
| + | *[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] | ||
| − | [http://wiki.hl7.org/images/ | + | *[http://wiki.hl7.org/images/b/b0/BRIDG_3.0.1_Comprehensive_Domain_Analysis_Model_pdf.zip PDF of BRIDG Model v3.0.1] |
| − | + | *[http://www.bridgmodel.org/ Link to BRIDG Model Website] | |
| − | [http://wiki.hl7.org/images/ | + | *[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] |
| − | [http://wiki.hl7.org/images/ | + | *[http://wiki.hl7.org/images/9/92/EudraCT-CTRR_Data_Requirements_BRIDG_Mapping_2010-03-17.zip BRIDG Mapping as of 2010-03-17] |
| + | ===Storyboards=== | ||
| − | + | [http://wiki.hl7.org/images/0/05/CTRR_Storyboards_v7.doc CTRR Storyboards V7] | |
| − | + | Previous versions removed... | |
| + | . | ||
| − | ===Activity | + | ===Activity, Interaction and Trigger Events Diagrams=== |
| + | |||
| + | [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=== | ===Other Documents=== | ||
| − | [http://wiki.hl7.org/images/ | + | [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== | ||
| Line 64: | Line 91: | ||
[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)] | [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=== | ||
| + | |||
| + | [http://wiki.hl7.org/index.php?title=EMEA_-_EudraCT EMEA - EudraCT Page] | ||
| + | |||
| + | . | ||
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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] | ||
| + | |||
| + | . | ||
===Protocol Representation – CDISC=== | ===Protocol Representation – CDISC=== | ||
[http://cdisc.org/standards/protocol.html Protocol Elements for Regulated Clinical Trials] | [http://cdisc.org/standards/protocol.html Protocol Elements for Regulated Clinical Trials] | ||
| + | [http://wiki.hl7.org/images/0/07/PRM-BRIDG_Mapping_15April2009.zip PRM Mapping to BRIDG] | ||
| + | |||
| + | . | ||
===CDISC-HL7 Study Participation Message=== | ===CDISC-HL7 Study Participation Message=== | ||
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===American Immunization Registry Association (AIRA) – Pediatric messages for immunizations=== | ===American Immunization Registry Association (AIRA) – Pediatric messages for immunizations=== | ||
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===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
Contents
- 1 Current Working Documents
- 2 Existing Artifacts relevant to the Project
- 2.1 CTSA (Clinical Translational Science Award)
- 2.2 CONSORT
- 2.3 CONSORT Mapping - CDISC
- 2.4 ClinicalTrials.gov
- 2.5 EMEA - EudraCT
- 2.6 WHO
- 2.7 Protocol Representation – CDISC
- 2.8 CDISC-HL7 Study Participation Message
- 2.9 CDISC-HL7 Study Design Message
- 2.10 CDISC-HL7 Study Data Message
- 2.11 BRIDG Model
- 2.12 CDISC ADAM
- 2.13 SAP – Statistical Analysis Plan
- 2.14 HL7 - Detailed Clinical Model (DCM)
- 2.15 EHR project
- 2.16 Public Health Emergency Response (PHER)
- 2.17 Mapping Protocol terms to MeSH
- 2.18 American Immunization Registry Association (AIRA) – Pediatric messages for immunizations
- 2.19 Other “older” organization registries, ie, American College of Cardiology
Current Working Documents
EudraCT Mapping Documents
- 2010-Jan14 Meeting Minutes
- 2010-Feb25 BRIDG SCC Validation of EudraCT mapping to BRIDG after Round 1 Comments from CTRR SubTeam
Storyboards
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)
-
.
EMEA - EudraCT
.
WHO
WHO Trial Registration Data Set Version 1.0
.
Protocol Representation – CDISC
Protocol Elements for Regulated Clinical Trials
.
CDISC-HL7 Study Participation Message
Study Participation Domain Analysis Model
CDISC-HL7 Study Design Message
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
