CDISC 360 is Rolling Strong

CDISC 360 is Rolling Strong

Peter Van Reusel

Chief Standards Officer, CDISC

The CDISC 360 project, introduced in the Q1 Newsletter and further described in the Q2 Newsletter, is rolling strong. Since our last reporting, project participants have completed three more agile sprints with significant progress.

Participation Continues to Grow

Participation has grown through the summer. Currently, 67 individuals from 29 member companies are contributing actively to the project, across six workstreams. With this large number of participants working remotely, across the globe, effective online collaboration tools are key to project success. As previously reported, project participant Microsoft, is providing its Azure product as a cloud collaboration platform. At this point, the platform instance has been configured and access has been provided to all project participants. A subset of participants is currently installing the software tools to build and run the scripts to execute the project use cases; these participants have already begun to build and run initial scripts!

Latest Agile Sprints Progress

Each of the six workstreams has completed the first expression of its user stories and sprint backlog, and has worked on backlog across three sprints in this quarter. Following are highlights:

  1. Standard Concepts Development:  Initial Biomedical Concepts have been defined, a concept template prepared from these learnings, and additional concepts are being defined from the template
  2. Concepts in CDISC Library:  Initial tooling has been developed to transform the standard concepts into a machine-readable form and subsequently, to transform them into a form that simulates content retrieved from  CDISC Library
  3. Use Case 1: this workstream has prepared a prototype version of a Study Metadata Library and loaded its first standard concepts into that library, and is currently developing scripts to search these concepts to select and assemble the end-to-end standard artifact definitions needed to build a given study
  4. Use Case 2:  This workstream has defined the components of a “360 Test Study” (based on the CDISC Diabetes Therapeutic Area User Guide) that will serve as  the basis for initially executing the three use cases of the project, and is currently defining their approach to generating the study metadata artifacts (ODM-based CRFs, define.xml, dataset shells) from the standard definitions delivered in Use Case 1
  5. Use Case 3:  This workstream has created data for the “360 Test Study” per the specifications provided by Use Case 2. They are now defining the metadata elements of the transformation metadata that will be added to the current structural metadata of the study artifacts to automate the population of these artifacts with data
  6. FDA Use Case:  This workstream has worked with project participants from FDA to identify the two safety endpoint analyses that will be part of the project, and has now begun to define the standard concepts for the first of these two analyses.

CDISC 360 at the 2019 US Interchange

There will be many opportunities to learn about CDISC 360 at the 2019 US Interchange. The Project will be the focus of the second Opening Plenary and include  presentations by CDISC Board Members Dave Evans and Chris Decker  CDISC VP, Data Science Dr. Sam Hume  and me. Sam’s presentation will include a demo of the progress made on the 360 Project to date. Next, a breakout session titled “CDISC 360 Use Cases - Industry Perspectives” will include a presentation on each of the three 360 Project use cases, delivered by the individual workstream leads. Finally, a post-conference CDISC 360 workshop will be held on Friday 18 October.

Looking Ahead

Following the US Interchange, CDISC 360 will enter its second six-month phase with several agile sprints planned until the 2020 Europe Interchange in Berlin. The workstream teams expect to build upon their knowledge gained in the early sprints, identify reasonable targets for the second six-month phase, and work down their respective agile sprint backlogs defined for those targets, all toward a more mature development of standard concepts and of execution of the three use cases. A more feature-rich demo will be planned for the 2020 Europe Interchange. A CDISC 360 web page on the CDISC web site is also planned for this period.

If you are an employee of a CDISC Member organization and interested in participating in CDISC 360, please send a message to