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Revision as of 17:37, 26 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 |
Minutes
Media:2009-01-08 Minutes CDISC RCIRM Terminology.doc
Media:2008-12-18 Minutes CDISC RCIRM Terminology.doc
