CDISC/RCRIM Terminology Call

CDISC/RCRIM Terminology Call

Date: Thursday, 08 January 2009

20 Participants: Amy Jacobs (Imco), Andreas Gromen (Bayer, Germany), Betsy Cook (Merck), Bill Hess ( FDA), Bron Kisler (CDISC), Chris Tolk (CDISC), Collen Bonjo (Merck), Debra Oneill (Merck), Dianne Reeves (NIH), Erin Muhlbradt (NCI EVS), Gerry Wade (HP), Jennifer Neat (COH), Julia Zhang (Genzyme), Karen Marakoff (Merck), Kristi Eckerson (Merck), Larry Wright (NCI EVS), Margaret Haber (NCI EVS), Peggy Zorn (Thomson Reuters), Randall Austin (GSK), Terry Hardin (IBM)

Regrets: Liz Nulton-Bodiford (GSK), Mary Lenzen (Octagon), Rachel Richesson (USF), Susan Timinski (Cephalon), Terry Quinn (NCI EVS)

Topic: CDISC/RCRIM terminology development and harmonization

1.  Upcoming meetings

-  HL7 RCRIM (next week)

Although most already have it, for those interested the agenda is available through the HL7 website. There is a Vocabulary session scheduled for Q4 Wednesday (January 14). Bron and Lise will be providing updates during this session.

-  CDISC INTRAchange (Feb 3-5)

The intrachange is CDISC’s working group meeting (held twice a year), where teams meet to work on cross-project harmonization. The schedule has been distributed. There may be a separate discussion regarding anatomical location on the afternoon of 5 February following the last session.

Action Point: A link to the location of the Intrachange will be included with the minutes.

Ronald Reagan Building and International Trade Center,
1300 Pennsylvania Avenue, NW, Washington, DC 20004

http://maps.google.co.uk/maps?f=q&hl=en&geocode=&q=Ronald+Reagan+Building+and+International+Trade+Center&sll=38.89144,-77.028585&sspn=0.011056,0.027895&ie=UTF8&ll=38.89363,-77.031015&spn=0.010655,0.027895&z=16

-  Terminology Team (Feb 6)

The Terminology Team will meet the morning of Friday (February 6) following the Intrachange. The plan will be to wrap up by 12-12:30 p.m. This is becoming standard practice for the terminology team since the members of the terminology team are active in other CDISC teams as well. Other team meetings will be held Tuesday during the INTRAchange. The Terminology Team Meeting will focus on finalizing 2009 terminology priorities and planning.

2.  CDISC Project Updates

-  Publication of SDTM & Labtest Package 3

All of the non-lab terms have been loaded into EVS and will be available for production in the near future. Chris has resent the lab terms provided the middle of December. Erin did not receive the original due to email anomalies. This will create a delay in production of the new Labtest terms.

The final disposition of comments is planned to be posted on the CDISC website.

Action Point: Chris will send the disposition of comments for both SDTM Package-3 and Labtest Package-3 and lab to the organizations / individuals, who provided comments.

-  CDASH Terminology

All CDASH controlled terminology (remaining from Appendix A) has been loaded/tagged in EVS, including synonyms. Most of the 115 terms matched terms already developed for use with the SDTMIG. In the case of an exact match, terms just needed to be tagged as CDASH terms.

-  SEND Terminology, including anatomical location

The draft SENDIG is in review by SDS team. The plan is for this review to be completed in the next month or two. The last major task is mapping organ names to NCI anatomical location terms. The team will also be reviewing terminology needs against the current implementation guide to ensure that all terms are covered. The next big effort for 2009 is to identify terminology needed for large animal studies including those that overlap with existing SDTMIG code lists (ECG, Vital Signs). Terms for the PK domain will be developed in collaboration with the SDS and Terminology teams.

The SEND team would like the lab terminology sub-team to focus on defining terms for CAT and SCAT. The lab terminology sub-team has investigated using the list provided by CLIA. http://www.fda.gov/cdrh/clia/downloaddata.html This was developed for instruments and is not applicable for our purposes. The decision by the SDS team was that there would be no controlled terminology for SCAT. This would allow sponsors to group terms as applicable for their use.

The SEND Terminology team will revisit in 2009 route of administration versus method and how it applies to animal data. The FDA has recently added terms FDA route of administration code list that are applicable for CVM. These terms will be made available in EVS. Currently the CDISC-SDTM route of administration codelist points to the FDA CDER Data Standards Manual.

NCI provides the FDA with a 24-hour turn-a-round on updates. As new terms are added to the CDER Data Standards Manual for route of administration, the CDISC terminology group will need to see if they should be added to the CDSIC terminology route of administration code list. As with other new terms, these will need to go terminology change control. The SEND team needs additional terms like “dietary”. A new variable may need to be added because this term is not a route of administration. The route would be ‘oral’.

Action Point: Bron and Chris will work with Bill Hess to come up with a process where CDISC could be notified that new terms have been added to the CDER Data Standards Manual. This needs to be added as an INTRAchange topic.

3.  Terminology requests, maintenance and versioning

The terminology request link on the NCI EVS page is up and running. The next CDISC Newsletter will include the link. A webcast will be set up for the next Terminology Team TC (January 22) to demonstrate how to use the request form.

Action Point: Chris to get webcast set up. Chris will enter a few actual requests, so the dummy test requests can be removed.

4.  FDA Vocabulary Projects – ICSR, RPS etc.

·  RPS – the initial 200 FDA preferred terms have been coded by the EVS team. These will be made available within the near future. There will be follow-up work needed for definitions, synonyms and hierarchy.

·  Work is currently being complete for guidance on Imaging Specification. Once released the FDA will be looking for pharma feedback. A public meeting will be scheduled within the next 6 months.

5.  Other RCRIM Projects - Lab Test Result AA, Clinical Trial Registry

·  Lab test abnormality – getting ready for testing of V3 message. Via EVS, the necessary concepts and codes needed for testing are complete. The new codes were approved by the HL7 harmonization committee. Additional terms may be needed in 2009.

6.  External Harmonization (ISO-Phil, HITSP-Bron/Bill, ICH)

·  HITSP – CDISC, FDA and others have been working with the harmonization subcommittee on route of administration, marital status and body site. The SDTM codelist of terms for Marital Status had previously been harmonized with HL7. HITSP has recommended several new terms that will be implemented by HL7 and other organizations. To stay aligned CDISC will consider the same via the terminology request /change control process. CDISC will continue to work with HITSP in 2009 on related terminology harmonization activities.

7.  2009 Terminology Priorities

Team discussed the draft spreadsheet listing potential 2009 terminology projects that include CDISC, FDA and RCRIM projects as well as US/global harmonization activities. Per discussion, Bron will update and redistribute spreadsheet one more time for final comments. BRIDG V3 – the release date for BRIDG version 3 has been delayed. When complete, there will need to be significant work around terminology gap analysis, development and harmonization.

8.  Future meetings…Others Items…Wrap up

Since the CDISC terminology and RCRIM vocab teams meeting jointly, the date and time for regular calls / meeting is confirmed during the HL7 RCRIM meeting. We do not anticipate any changes for 2009, but will confirm schedule next week.

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