CDISC Blog

CDISC co-sponsored and participated in the ISO TC-215 meetings this past week in Rio de Janeiro, Brazil. It was an amazing week with Dr. Christopher Chute assuming the helm of ISO TC-215 Health informatics as Chairperson. It was a productive meeting for CDISC with positive movement on many fronts, beginning with a CDISC presentation to international delegates from Brazil, Singapore and Australia. The presentation and discussion was successful in informing countries in the Southern Hemisphere and Southern Asia about existing CDISC standards, links to healthcare (e.g. BRIDG, HL7) and plans for 2010 and beyond, namely disease standards and CDISC SHARE. Clear next steps are in place with each of these regions to ensure these standards marketplaces remain fully informed, as they further evaluate the role of CDISC standards.

The BRIDG model is well on its way to becoming an internationally recognized standard. As a Joint Initiative Council project for global standards harmonization, the BRIDG model was successfully balloted across 3 global standards organizations simultaneously - ISO, HL7 and CDISC. Having just begun the JIC process in January, BRIDG quickly passed both the ISO and HL7 ballots as well as the CDISC process last week. 250 total comments were received, and are being resolved during the back-to-back ISO and HL7 meetings. In ISO TC-215 Work Group 2, BRIDG was approved by 14 countries - Austria, Brazil, Canada, Czech Republic, Denmark, Germany, Japan, Korea, Malaysia, Netherlands, Spain, Turkey, United Kingdom and the United States. Only one county voted negative with comments, which are currently being addressed. 10 countries abstained.

During the Joint Initiative Council (JIC) meeting last week, the Clinical Trials Registration and Results project (CTR&R) was officially confirmed as a JIC project. CTR&R passed the HL7 ballot, and an ISO New Work Item Proposal is being drafted for review and approval by the ISO community. CTR&R will undergo the same ISO balloting process as BRIDG, and is already harmonized with BRIDG. The CTR&R project is creating a global standard for interchanging clinical trial registration information with a registry. Currently, the registries providing requirements are clinicaltrials.gov (US), EudraCT (EU) and WHO Clinical Trial Registry.

The ISO week concluded with the 11th International HL7 Interoperability Conference - IHIC 2010. Bron Kisler (CDISC Senior Director) was invited to present on the global TB data standards initiative. The presentation entitled - Disease-specific Data Standards: A Global Project and Case Study in Tuberculosis - provided a history of TB standards development, balloted by both CDISC and HL7 in 2008. Also highlighted, were ongoing implementation and demonstration activities by US Centers for Disease Control and Food & Drug Administration as well as a new initiative called The Critical Path to TB Regimens recently launched by the Global TB Alliance, Bill & Melinda Gates Foundation and Critical Path Institute. CDISC and many others with interest in speeding development of new TB drug combinations will participate in the launch workshop scheduled for June 9-10 in Washington DC.

Bron Kisler & Julie Evans