RCRIM Vocabulary

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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


Media:2011-03-31 Minutes RCRIM Terminology Call FINAL.doc

Media:2011-02-17 Minutes RCRIM Terminology Call FINAL.doc

Media:2011-02-03 Minutes RCRIM Terminology Call FINAL.doc

Media:2011-01-20 Minutes RCRIM Terminology Call FINAL.doc

Media:2011-01-06 Minutes RCRIM Terminology Call FINAL.doc

Media:2010-12-09 Minutes RCRIM Terminology Call FINAL.doc

Media:2010-11-11 Minutes RCRIM Terminology Call FINAL.doc

Media:2010-10-28 Minutes RCRIM Terminology Call FINAL.doc

Media:2010-10-14 Minutes RCRIM Terminology Call FINAL.doc

Media:2010-09-23 Minutes RCRIM Terminology Call FINAL.doc

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Media:2009-07-23 Minutes RCRIM Terminology Call FINAL.doc

Media:2009-06-25 Minutes RCRIM Terminology Call FINAL.doc


Media:2009-04-30 Minutes RCRIM Terminology Call FINAL.doc

Media:2009-04-16 Minutes RCRIM Terminology Call FINAL.doc

Media:2009-03-19 Minutes RCRIM Terminology Call FINAL.doc

Media:2009-03-05 Minutes RCRIM Terminology Call FINAL.doc

Media:2009-02-19 Minutes RCRIM Terminology Call FINAL.doc

Media:2009-02-06 Minutes Terminology f2f Meeting AMENDED (2).doc

Media:2009-01-22 Minutes CDISC RCRIM Terminology.doc

Media:2009-01-08 Minutes CDISC RCIRM Terminology.doc‎

Media:2008-12-18 Minutes CDISC RCIRM Terminology.doc‎

Media:2008-12-11 Minutes CDISC RCRIM Terminology.doc


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