This wiki has undergone a migration to Confluence found Here
CTRR Working Documents
Jump to navigation
Jump to search
Return to CTRR main page
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)
ClinicalTrials.gov Basic Results - Data Element Definitions (DRAFT)
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
