As a CDISC Platinum Member, PROMETRIKA has the opportunity to sit on the CDISC Advisory Council (CAC), which plays an important role in shaping CDISC’s development and direction. Platinum Member representatives serve on the CAC, contributing industry expertise and sharing real-world implementation experiences. The CAC represents a cross-section of organizations within the pharma industry; thus, making them a part of the review process for assessing and revising standards. Collectively, the CAC provides the CDISC Executive Team with recommendations that further the CAC mission of “unifying the voices of membership to influence and support CDISC goals.”

At a recent CAC meeting, a new Task Force was convened to review key proposed changes in the draft SDTMIG version 4.0. I’m honored to be the only representative of a small CRO among the 15 volunteer members of the Task Force. We learned that, based on industry feedback, there is a disconnect between those who serve as SME’s on CDISC volunteer standards development teams versus those who are responsible for standards implementation. Breaking backward compatibility between standards’ version releases may incur significant cost through requiring up-versioning of processes and datasets, and also present challenges for data use in analysis.

I participated in the development of a questionnaire covering several categories of concern over implementing standards changes. Each Task Force member company was asked to summarize their feedback in a standard template that included:

  1. Does your organization support the proposed change? (Yes or no)
  2. Describe the overall impact to your organization
  3. Estimate the effort to modify process documents (scale 1-5: easy to difficult)
  4. Estimate the effort to modify programs (1-5)
  5. Estimate the effort to validate programs (1-5)
  6. Concerns/comments

The Task Force was chartered with reviewing nine major proposed standards changes:

  • Change Supplemental Qualifiers to a Non-Standard Variable Representation
  • Add the QRS Instrument Reference (QX) domain
  • Handle Multiple Subject Instances by adding the DC domain
  • Restructure the Metadata to match SDTM 2.0
  • Reorganization / rewrite of Sections 1-4
  • Add a new variable to Protocol Deviations (DV) to capture DV classifications (e.g. important vs non-important)
  • Add an Event Adjudication (EA) domain
  • Deprecation of Baseline Flag (–BLFL) to let –LOBXFL take its place
  • Deprecation of the derived Pharmacokinetics Parameters (PP) domain

The first draft version of SDTMIG 4.0 is expected to be released for public comment later this summer, which will give everyone else in the industry the opportunity to take part in the development process by reviewing the standards and providing their comments.

PROMETRIKA remains greatly committed to participating in industry activities to improve methods and standards and I am excited to be part of the efforts of CDISC. Participation in standards development positions PROMETRIKA to swiftly implement changes as they are released, to support our clients in their clinical research efforts and regulatory submissions. To learn more about PROMETRIKA’s CDISC services, visit our CDISC page.

“At a recent CAC meeting, a new Task Force was convened to review key proposed changes in the draft SDTMIG version 4.0.”

Susan Mutter

Susan Mutter

Director, Statistical Programming

Share This Article