RCRIM Vocabulary

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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