Difference between revisions of "CTRR Working Documents"
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===Protocol Representation – CDISC=== | ===Protocol Representation – CDISC=== | ||
| + | [http://cdisc.org/standards/protocol.html Protocol Elements for Regulated Clinical Trials] | ||
===CDISC-HL7 Study Participation Message=== | ===CDISC-HL7 Study Participation Message=== | ||
| + | [http://wiki.hl7.org/images/b/bb/StudyParticipationDAM.zip Study Participation Domain Analysis Model] | ||
===CDISC-HL7 Study Design Message=== | ===CDISC-HL7 Study Design Message=== | ||
| + | [http://wiki.hl7.org/images/4/48/StudyDesignDAM.zip Study Participation Domain Analysis Model] | ||
| + | |||
| + | |||
| + | ===CDISC-HL7 Study Data Message=== | ||
Revision as of 16:59, 25 February 2009
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 Protocol Representation – CDISC
- 2.6 CDISC-HL7 Study Participation Message
- 2.7 CDISC-HL7 Study Design Message
- 2.8 CDISC-HL7 Study Data Message
- 2.9 BRIDG Model
- 2.10 CDISC ADAM
- 2.11 SAP – Statistical Analysis Plan
- 2.12 HL7 - Detailed Clinical Model (DCM)
- 2.13 EHR project
- 2.14 Public Health Emergency Response (PHER)
- 2.15 Mapping Protocol terms to MeSH
- 2.16 American Immunization Registry Association (AIRA) – Pediatric messages for immunizations
- 2.17 EudraCT/EMEA
- 2.18 WHO
- 2.19 Other “older” organization registries, ie, American College of Cardiology
Current Working Documents
Storyboards
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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Protocol Representation – CDISC
Protocol Elements for Regulated Clinical Trials
CDISC-HL7 Study Participation Message
Study Participation Domain Analysis Model
CDISC-HL7 Study Design Message
Study Participation Domain Analysis Model
CDISC-HL7 Study Data 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
