CDISC Blog

As many of you know, CDISC began as a volunteer group in 1997 and was accredited as a Standards Developing Organization (SDO) in 2000.  Since that time, we have had strategic decisions to make in terms of our scope and our strategy for accreditation. In terms of accreditation, CDISC took a different path than its key collaborator, Health Level Seven (HL7). Specifically, HL7 chose to become accredited by the American National Standards Organization (ANSI). When HL7 started over 20 years ago, this was a very logical choice in that environment. However, they have now struggled with a ‘label’ that they are an American standards organization despite the fact that they have numerous international affiliates and their standards are used internationally. They are making concerted efforts to establish their “internationality” and are gradually convincing their stakeholders that they are global.  

Clinical research is certainly global. For this reason, CDISC chose to go directly to ISO to appeal to become an ISO Liaison. In 2007, Liaison A status was granted, meaning that CDSIC can take its standards directly to ISO at the highest level, i.e. a fast track. In addition, the step of becoming an ANSI standard is not a necessary prerequisite. That being said, CDISC works with national standards bodies wherever we can have representation. We have a membership with ANSI and participate in the ISO Technical Advisory Group in the U.S. We also have a membership in the UK standards body and CDISC ‘friends’ or representatives in other national standards bodies such as Sweden and Japan.  

CDISC is also a member of the Joint Initiative Council (JIC) for international harmonization of standards. This council was initiated through HL7, ISO and CEN (European Committee on Normalization – need to check this). Their first project was to standardize on datatypes, which CDISC plans to use in SHARE. CDISC was officially added as a JIC member in 2008 and in 2009 the International Health Terminology SDO (IHTSDO or SNOMED) was also added as the fifth SDO in the JIC.  

Several new JIC projects are of interest to CDISC, including the Individual Case Safety Report (ICSR) that involves ICH, the Identification of Medical Products (IDMP), the Clinical Trial Registry and Results  (CTRR) message and now BRIDG. This means that BRIDG will be balloted simultaneously through ISO, HL7, CDISC (and CEN and IHTSDO if they choose to participate).

At the meetings in Edinburgh, BRIDG was proposed as a New Work Item Proposal (NWIP) at ISO. The ballot took place before the Durham meetings (Approval of the NWIP required support and experts named from at least five countries). In Durham, Becky Kush spoke as a JIC leader at the Global Summit on Sunday (theme of global eHealth) and attended the JIC meetings on Tuesday d Julie and Bron presented BRIDG to ISO working groups 1 and 2 on Tuesday as part of the JIC process to turn BRIDG into an ISO standard. CDISC open public review of BRIDG Release 3 is now taking place and this will constitute an ISO balloting step (CD) concurrently. Throughout the week, Bron also participated in Workgroup 6 (with EMEA, ICH, PMDA and FDA representatives) to resolve the Identification of Medical Products (IDMP) ballot results from JIC.

CDISC is also a member of the SDO Charter Organization (SCO) which is more concerned with standards in America at the moment, although HL7 and CDISC are global organizations and wish to ensure that the local standards fit into the global landscape.  Clearly, there are harmonization opportunities. Vendors, biopharmaceutical companies and others interested in global research and healthcare are not keen for the US to settle on a US-centric standard that will not serve global purposes. CDISC will be hosting the next meeting of the SCO in Baltimore on 13 November, just after the Interchange.
So, what makes an SDO? According to the American National Standards Institute (ANSI), the essential requirements for due process to develop a standard are:  Openness (in terms of participation in the development), Lack of dominance (by any single interest), Balance (of interests in terms of participants), Coordination and harmonization (between and among standards), Notification of standards development, Consideration of views and objections, Consensus vote (documented), Appeals, and Written procedures.  

CDISC is in the process of comparing its Standards Development Process (COP-001) and comparing it with the others in the Joint Initiative Council (JIC). This has been an interesting and informative exercise. A few interesting items that come to light about the CDISC process in this comparative setting are a) it takes advantage of electronic processes and current technology more than other SDOs in the broader healthcare space, not being tied to face-to-face meeting dates; b) it is relatively streamlined, even though we are currently looking at ways to make it faster and better, particularly for terminology development; and, c) CDISC standards are open and freely available while others tie their business models to either providing standards only to members and/or charging fees for their standards.

We would like to keep the CDISC standards open and freely available; however, this requires that we continue to receive adequate funding through other sources such as memberships, educational courses, personnel (volunteers), grants and other means. Thank you to those of you who have contributed in whatever way and if you feel you can make a difference please become a member.