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CTRR Working Documents
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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)
[1] Informatics : Use Cases for the CTSA Human Studies Database project
CONSORT
The CONSORT statement (Consolidated Standards of Reporting Trials)
CONSORT Mapping - CDISC
[2] WHO Minimum trial Report to ICH E3 and CDISC Protocol Representation, CDISC SDTM (in BRIDG Model)
[3] Comparison and Rating of Clinical Trial Reporting Elements (ICH E3, CONSORT, WHO)
ClinicalTrials.gov
Protocol Representation – CDISC
CDISC-HL7 Study Participation Message - Study Design Message
BRIDG Model
[7] 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
WHO
[10] WHO Trial Registration Data Set Version 1.0
