Shannon Labout, Interim Chief Standards Officer, VP Education, CDISC

As we travel around the globe, meeting and interacting with our stakeholders, CDISC is listening. We hear you and are committed to doing everything we can to support our community and to make the standards better.

At our International Interchange last month, I presented during our Opening Plenary session on What’s New and What’s Next at CDISC, and want to share some of that information with the CDISC community in this newsletter article.

What’s New?

More Support to Volunteers

CDISC relies on the subject matter expertise of thousands of volunteers to create vendor-neutral, platform-independent data standards. To provide more support to our volunteers, we are instituting a number of initiatives, including:

  • Setting clear expectations through enhanced training on policies and procedures
  • Providing training and staff support for tools, such as Wiki and Jira
  • Tracking volunteer hours (actually, this is a legal requirement and helps us know how to resource projects. It’s also a great way to quantify our volunteers’ contributions to the CDISC mission).
  • Providing succession planning for team leadership to provide continuity while avoiding burnout

Improved Standards Development Process

For many years, most of the CDISC teams have worked in silos, with each team having its own governance. A few years ago we instituted central governance by setting up the Standards Review Council (SRC). The SRC’s job was to review standards before they went out for public review, and before final publication, to ensure more consistency and higher quality.  Unfortunately, SRC review happened so late in the development process that sometimes things were sent back to the teams for re-work after significant development efforts had already been done. This problem was addressed by implementing a new team called the Modeling Review Council (MRC). MRC was put in place to provide early review and advice on standards in development. This solution improved processes because we caught issues earlier before teams put in significant development work. However, MRC was not a governance body, and it was still possible for the individual standards governance teams to make conflicting or inconsistent decisions. We had made significant improvements, but knew we could do better.

As of October, we have consolidated standards development governance for all standards into one decision-making body - the Global Governance Group (GGG), which meets weekly and is open to all active volunteers. The GGG consists of appointed representatives from each Foundational Standards team who review and approve normative (domains, variables and classes) and informative (examples, text explanations) content prior to internal review, public review and publication. Benefits of the GGG include inclusive, transparent decision-making that is documented consistently across all standards teams, as well as early, cross-team review to ensure cross-standard alignment, and reduce future rework.

Tools for Standards Development

For some time now, CDISC has provided the following tools to enhance global collaboration during the standards development and review processes and encourage transparency along the way.

  • Wiki (wiki.cdisc.org) – A team collaboration space that serves as a repository of draft standards. Teams uses the Wiki to share information relevant to developing and using standards. 
  • JIRA (JIRA.cdisc.org) – An issue-tracking tool to manage internal and public review comments, gather requests for future development, and manage the publication process.

Over the last year, the CDISC SHARE Team has created the following Wiki tools to support teams in developing standards …with more tools in the pipeline.

  • CRF Maker uses CDASH metadata to create annotated eCRF representations, allowing teams to develop higher quality CRF examples.
  • SDS Maker is a suite of tools that aid the development and capture of metadata and examples in the context of SDTM for human clinical trials. SDS Maker provides the ability to QC SDTM-based metadata, ensuring higher quality with less team effort.

 

2018-2020: What’s Next

Accredited Training Program

CDISC training programs went through a rigorous independent evaluation and audit process over the last few years and, as we announced in last quarter’s newsletter, CDISC Education received accreditation from the International Association of Continuing Education and Training (IACET). 

CDISC Education is now the only IACET-accredited training organization in the world authorized to teach CDISC standards. This is a measure of the quality of our program.  It also means that you can now receive continuing education units (CEUs) while learning CDISC standards from our authorized industry experts. Learn more.

This accreditation also lays the groundwork for our next step, which is to offer CDISC standards certification to individuals.  Stay tuned for more news about this in 2018.

Predictable Release Schedule

To increase transparency and predictability, CDISC has initiated an annual release schedule, which will begin in 2018. A list of standards in development will be maintained on our web site so that you can follow the standard throughout the development process see what’s coming and when to expect publication of the standard. Note:  Not all standards will have an annual release every year.

More Complete Content

In addition to delivering more predictability, in order for a standard to be published as “final”, it will be required to include the normative standard, informative examples and text, conformance rules, necessary Controlled Terminology, with all metadata available in CDISC SHARE Exports, and that relevant learning outcomes have been approved for training purposes. These parameters for a final standard improve implementation.

New Publishing Formats

In September we piloted the release of our first HTML standard – CDASHIG v2.0 and CDASH Model v1.0. Publishing in HTML expedites delivery of the standard and allows users to search for keywords within the page and bookmark the information in a browser. Additionally, HTML is more universally readable than PDF, can be saved for offline use and as other file formats and can be printed.

Development Principles

Each standards team is in the process of documenting the development principles for the standard they are helping to develop. This practice is necessary to preserve the knowledge of each team, to facilitate future decision making, help optimize utilization of resources, assist in managing change, and build a knowledge base for future development.

Future of CDISC Standards

We have accomplished so much as an organization with dedicated, passionate volunteers over the past 20 years; in fact, working together we have done what many people said could not be done. I’m so grateful for our volunteers, staff who support them, and of the accomplishments we have achieved together. CDISC standards are widely accepted, required and used - in part because they have been created by this volunteer community through an open, publicly transparent process. 

Historically, these volunteer standards development teams have worked more or less independently from each other. As mentioned earlier, CDISC now has a centralized governance in the GGG. But an inevitable consequence of the historically siloed teams is that subtle differences within, and among the Foundational standards, have occurred over the years. Full harmonization and consistency within, and across related standards, will be required for our standards to support our community’s goals of meaningful data sharing and beginning-to-end process automation. To address this, in 2018, CDISC is planning an in-depth review and refinement of all our standards metadata to identify and resolve these inconsistencies. Other initiatives, such as cross-team development of variable definitions, cross-team alignment of core designations, and developing biomedical concept templates, will allow us to re-tool for future development in a more harmonized and higher quality environment.

All of these innovations are part of our strategic roadmap that will allow us to evolve alongside the ever-changing and innovating landscape that is clinical research.  We look forward to working with you on the journey!