Minutes RCRIM Terminology Call

Date: Thursday August 20, 2009

17 Participants: Melissa Binz (Wyeth), Betsy Cook (Merck), Melissa Cook (Millennium Pharmaceuticals), Margaret Haber (NIH),Amy Jacobs (Imco), Bron Kisler (CDISC), Karen Marakoff (Merck), Erin Muhlbradt (NCI EVS), Debbie O’Neill (Merck), Sophia Paterakis (Amgen), Terry Quinn (NCI EVS), Ranjana Srivastava (Booz Allen Hamilton), Chris Tolk (CDISC), Gerry Wade, Larry Wright (NCI EVS),Julia Zhang (Genzyme), Peggy Zorn (Thomson Reuters)

Regrets:Randall Austin (GSK),Frank Senk (Astra Zeneca)

Topic: CDISC/RCRIM terminology development and harmonization

  1. Approval of Minutes from July 23

The minutes were approved as written. Reminder: all final minutes are published on the HL7 wiki.

  1. Update on FDA Vocabulary Projects

NCI is working with the FDA to review tumor terminology to understand the FDA terminology needs for tumor types. Representatives from different FDA divisionsare on this team. Therehas been discussion to have a variable to hold the neoplastic status (ie, malignant, benign, etc).

  1. Update on other RCRIM Projects

No update.

  1. External Harmonization

The following question was raised in an email from Karen Marakoff : “Specifically, Betsy was referring to the international standard proposed by HL7 forIdentification of Medicinal Products (ISO TC 215, prEN ISO 11238, 11239, 11240, 11615, 11616).These are standards that ISO has developed at ICH's request. There are a set of 5 data standards that lay out a model for medicinal products. Many of the attributes in the model are to be backed with controlled terminologies - including dosage form, routes of administration, units of measurement. In the documentation it is stated that they will be surveying the existing standard terminologies and that a maintenance organization for controlled vocabularies would be appointed by ISO.The business cases listed for using this datainclude both pharmacovigilance and clinical trials.We were hoping that they had approached CDISC as we would hate to see a conflict in vocabulary standards. Any future information that you could share on this topic would be much” appreciated.

Discussion: Through the ISO process some terminology lists have been standardized. Those include medicinal products, dosage form, route of administration, position and units. Many organizations participated in this process including CDISD, HL7, NCI, FDA and the US/Japan/EU regulatory bodies. The JIC (Joint Initiative Council) was formed with representatives from CDISC, ISO, HL7 and CEN. Terminology development within JIC works slowly because agreement is neededacross many countries. This is the first time ISO and JIC have worked on the development of this kind of terminology. There has been no decision on the maintenance of terms. Margaret has provided requirements to this group for a maintenance organization that include business, funding and update requirements. NCI EVS maintains standard terminology for many of these organizations. This terminology does not have tags as to who developed it. CDISC users should just access the controlled terminology from NCI EVS with the understanding that this terminology has been aligned.

  1. New Term Request Mechanism

In July we have received 20 requests, 17 type III (new terms), two type II and one type I. In August one request has been entered.

The terms from Q1 were posted in error on the CDISC website. We are in the process of working with the company that maintains our website to post the terms from Q2Type II and III requests.

Action Point: Chris will check the website and inform this team when the correct terms have been posted.

  1. Update on CDISC Terminology
  2. Projects
  • SDTM - Chris has completed the assessment of terminology needs for SDTMIG V3.1.2. The new development needs were divided into three groups, one for PK, one for microbiology and the third with the additional terms. All three teams have been meeting weekly or every other week. Gerry Wadeis leading the ‘Miscellaneous/General Team’ team. The “Method”and all other code lists identified for this team have been completed. Erin and Terry are developing definitions for the terms. Phil and Chris are leading the Microbiology team. This team has representatives from the FDA on it. Erin has merged three microorganism lists together to start the development of the bug list. The third team to develop PK terminologyis lead by Nicola Stein (Bayer HealthCare - Berlin). This team is meeting weekly to develop terms for PK parameters. The CDISC representative from Pharsight, the company that markets the software that most pharmaceutical companies use for PK parameter data has joined the team to help with PK parameter controlled terminology.
  • SEND - the SEND terminology team’s tumor type code list is out for review. The team is currently reviewing code lists used for the ECG and Vital Signs domains for use in large animals. So far there is a fairly good match. The SEND team will have a meeting in Washington DC September 14-17. Erin and Terry will check to see if a webex could be offered.
  • ADaM - The terminology set is complete. Randall sent the final list to Chris.
  • Lab - The lab test terminology team has almost completed the work on Version 4 lab test names. There are just a few terms that need some additional explanations from the person who submitted the term. Chris is working on resolving these questions. Erin is has completed the definitions. There are approximately 180 new terms that are in development.
  • Governance/Implementation Team - Presentations from team members on terminology implementation at their companies is complete. The project plan has been drafted and is in review. Additional ways to display the spreadsheet (xml) need to be discussed.
  • Glossary - It has become clear from the terminology discussions at the CDISC Intrachange that we need to align the glossary terms across CDISC and add to NCI EVS. Chris has sent emails to Art Gretel, the team lead. Action Point: Chris will discuss with Dave Iberson-Hurst the need to move the glossary development into the terminology process and move the process along.
  • Oncology - Chris had a preliminary meeting with Barrie Nelson to discuss the terminology needs for the new oncology domains currently in development. The first TC will take place on August 24 to start the process.

Colleagues from NCI EVS are members on all of these teams. The goal of all the teams is to have the development completed by the end of September, public review in October and all terms in production by the end of 2009.

  1. AOB

Update on other development activities - this will be added as a regular agenda item. Chris and Bron participate in several terminology development activities.

  • TB - development of the data elements was completed in 2008. This document is maintained on the CDISC website. There was recent meeting hosted by the FDA on drug resistant TB.
  • Cardiovascular - development of the data elements was completed in 2008. This document is maintained on the CDISC website.Another group of medical colleagues will be meeting with representatives from the FDA, industry and acedemia to add about 100 additional cardiovascular elements. The kick-off meeting is set for September 11.
  • Polycystic Kidney Disease (PKD) - The kick for the development of PKD standard data elements is set for August 27 and 28 with colleagues from PKD Foundation, FDA and CDISC.
  • Alzheimer and Parkinson’s Disease (CAMD) - This group is developing standards for both Alzheimer’s and Parkinson’s disease. The group is currently mapping the SF36 questionnaire. A two day meeting will be held on August 25 and 26.

Next TC:The next TC will beThursday, September 3, 2009.

Drafted: C. Tolk/August 20, 2009

Approved: September 3, 2009