Difference between revisions of "CTRR Working Documents"
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===ClinicalTrials.gov=== | ===ClinicalTrials.gov=== | ||
| − | [http://wiki.hl7.org/images/2/24/ClinicalTrials.gov_Data_Element_Definitions_%28DRAFT%29.pdf ClinicalTrials.gov Protocol Data Element Definitions (DRAFT)] | + | [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] |
| − | [ | + | [https://register.clinicaltrials.gov/prs/html/definitions.html ClinicalTrials.gov Protocol Data Element Definitions (Direct Link)] |
| − | [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 ( | + | - |
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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] | ||
| + | |||
| + | [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)] | ||
===Protocol Representation – CDISC=== | ===Protocol Representation – CDISC=== | ||
Revision as of 21:51, 12 February 2009
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Contents
- 1 Existing Artifacts relevant to the Project
- 1.1 CTSA (Clinical Translational Science Award)
- 1.2 CONSORT
- 1.3 CONSORT Mapping - CDISC
- 1.4 ClinicalTrials.gov
- 1.5 Protocol Representation – CDISC
- 1.6 CDISC-HL7 Study Participation Message - Study Design Message
- 1.7 BRIDG Model
- 1.8 CDISC ADAM
- 1.9 SAP – Statistical Analysis Plan
- 1.10 HL7 - Detailed Clinical Model (DCM)
- 1.11 EHR project
- 1.12 Public Health Emergency Response (PHER)
- 1.13 Mapping Protocol terms to MeSH
- 1.14 American Immunization Registry Association (AIRA) – Pediatric messages for immunizations
- 1.15 EudraCT/EMEA
- 1.16 WHO
- 1.17 Other “older” organization registries, ie, American College of Cardiology
Existing Artifacts relevant to the Project
CTSA (Clinical Translational Science Award)
Informatics : Use Cases for the CTSA Human Studies Database project
CONSORT
The CONSORT statement (Consolidated Standards of Reporting Trials)
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)
-
Protocol Representation – CDISC
CDISC-HL7 Study Participation Message - Study Design Message
BRIDG Model
clinicaltrials.gov mapping document to BRIDG 2.1
CDISC ADAM
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
EudraCT/EMEA
List of Fields Contained in the EUDRACT Clinical Trials Database
Paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT)
WHO
WHO Trial Registration Data Set Version 1.0
