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Difference between revisions of "RCRIM Vocabulary"

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==Regulated Clinical Research Information Management (RCRIM) Vocabulary==
 
==Regulated Clinical Research Information Management (RCRIM) Vocabulary==
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{| {{table}}
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| align="center" style="background:#f0f0f0;"|'''Organization'''
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| align="center" style="background:#f0f0f0;"|'''2009 Terminology Projects (CDISC, RCRIM-FDA, other)'''
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| align="center" style="background:#f0f0f0;"|'''Quarter'''
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|-
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| ||||
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|-
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| CDISC||1. Terminology Requests: implement terminology request mechanism via EVS and CDISC website||Q1
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|-
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| CDISC||2. Terminology Maintenance & Versioning: governance, decision-making & versioning process||Q1
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|-
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| CDISC||3. SDTM 3.1.2: address new domains (MB-1&2, PK-1&2, CE, FA) working across CDISC teams||Q1-Q2
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|-
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| CDISC||4. SDTM Labtest: extend Labtest terms per industry needs and requirements||Q2-Q3
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|-
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| CDISC||5. SDTM other: consider new domains planned for 2009 (e.g., Oncology, Devices)||TBD
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|-
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| CDISC||6. CDASH: finalize CDASH-SDTM codelist alignment via terminology request mechanism||Q1-Q2
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|-
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| CDISC||7. CDASH: tag CDASH ver1.0 Appendix A terms and make available through EVS||Q1
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|-
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| CDISC||8. SEND: Develop PK terms with SDTM; ECG, VS, Location / Specimen, Route of Administration||Q1/Ongoing
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|-
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| CDISC||9. Terminology Implementation: assess/document user implementation requirements; develop IG||Q2/Ongoing
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|-
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| CDISC||10. Terminology Training: extend terminology training to 1/2 day with CDASH and SDTM||Q1-Q2
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|-
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| CDISC||11.  CDASH/SDTM: assess need to code CDASH-SDTM field names; harmonization caBIG||Q2-Q3
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|-
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| CDISC||12. Other CDISC standards? e.g. C-MDR, ADaM, Protocol Representation, etc.||TBD
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|-
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|-
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| RCRIM-CDISC-NCI||13. BRIDG Project: assess terminology/coding needs for metadata & codelist terms; align with CDISC production terminology standards (SDTM, CDASH); development to address gaps||Q2-Q3
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|-
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| RCRIM-FDA||14. RPS Release 1: terminology development, harmonization and publication (start w/ FDA terms)||Q1/Ongoing
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|-
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| RCRIM-FDA||15. RPS Release 2: terminology alignment with RPS Release 1; develop terms to address gaps||Q1/Ongoing
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|-
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| RCRIM||16. Study Design (CDISC-HL7 Message)||TBD
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|-
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| RCRIM||17. Study Participation (CDISC-HL7 Message)||TBD
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|-
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| RCRIM||18. Subject Data (CDISC-HL7 Message)||TBD
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|-
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| RCRIM||19. Clinical Trial Registry||TBD
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|-
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| RCRIM||20. Labtest Result Abnormality Assessment||Q2?
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|-
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| HL7-ISO-FDA||21. ICSR (FDA): gap analysis with SDTM & SEND; terminology development & harmonization||Q1/Ongoing
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|-
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|-
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| ISO||22. ISO: TC-215 WG-6 Identification of Medicinal Projects (IDMP); also WG-3 activities||Ongoing
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|-
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| HITSP||23. HITSP: terminology harmonization via Harmonization Subcommittee||Ongoing
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|-
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| JIC||24. Joint Initiaitve Council: terminology harmonization w/ ISO, CDISC, CEN, HL7, IHTSDO||Ongoing
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|-
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| ICH||25. International Conference on Harmonization: regulatory harmonization (US, EU JPN)||Ongoing
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|-
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Revision as of 17:25, 22 January 2009

Return to RCRIM main page

Welcome to the HL7's RCRIM Vocabulary wiki page.

Regulated Clinical Research Information Management (RCRIM) Vocabulary

Organization 2009 Terminology Projects (CDISC, RCRIM-FDA, other) Quarter
CDISC 1. Terminology Requests: implement terminology request mechanism via EVS and CDISC website Q1
CDISC 2. Terminology Maintenance & Versioning: governance, decision-making & versioning process Q1
CDISC 3. SDTM 3.1.2: address new domains (MB-1&2, PK-1&2, CE, FA) working across CDISC teams Q1-Q2
CDISC 4. SDTM Labtest: extend Labtest terms per industry needs and requirements Q2-Q3
CDISC 5. SDTM other: consider new domains planned for 2009 (e.g., Oncology, Devices) TBD
CDISC 6. CDASH: finalize CDASH-SDTM codelist alignment via terminology request mechanism Q1-Q2
CDISC 7. CDASH: tag CDASH ver1.0 Appendix A terms and make available through EVS Q1
CDISC 8. SEND: Develop PK terms with SDTM; ECG, VS, Location / Specimen, Route of Administration Q1/Ongoing
CDISC 9. Terminology Implementation: assess/document user implementation requirements; develop IG Q2/Ongoing
CDISC 10. Terminology Training: extend terminology training to 1/2 day with CDASH and SDTM Q1-Q2
CDISC 11. CDASH/SDTM: assess need to code CDASH-SDTM field names; harmonization caBIG Q2-Q3
CDISC 12. Other CDISC standards? e.g. C-MDR, ADaM, Protocol Representation, etc. TBD
RCRIM-CDISC-NCI 13. BRIDG Project: assess terminology/coding needs for metadata & codelist terms; align with CDISC production terminology standards (SDTM, CDASH); development to address gaps Q2-Q3
RCRIM-FDA 14. RPS Release 1: terminology development, harmonization and publication (start w/ FDA terms) Q1/Ongoing
RCRIM-FDA 15. RPS Release 2: terminology alignment with RPS Release 1; develop terms to address gaps Q1/Ongoing
RCRIM 16. Study Design (CDISC-HL7 Message) TBD
RCRIM 17. Study Participation (CDISC-HL7 Message) TBD
RCRIM 18. Subject Data (CDISC-HL7 Message) TBD
RCRIM 19. Clinical Trial Registry TBD
RCRIM 20. Labtest Result Abnormality Assessment Q2?
HL7-ISO-FDA 21. ICSR (FDA): gap analysis with SDTM & SEND; terminology development & harmonization Q1/Ongoing
ISO 22. ISO: TC-215 WG-6 Identification of Medicinal Projects (IDMP); also WG-3 activities Ongoing
HITSP 23. HITSP: terminology harmonization via Harmonization Subcommittee Ongoing
JIC 24. Joint Initiaitve Council: terminology harmonization w/ ISO, CDISC, CEN, HL7, IHTSDO Ongoing
ICH 25. International Conference on Harmonization: regulatory harmonization (US, EU JPN) Ongoing
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