Standards Development High-Level Principles

Standards Development Guiding Principles

Statement:

Consider the needs of stakeholders at all levels and functions (e.g., data creation, cleaning, analysis and review).

Rationale:

Standards are only effective if adopted, and standards are only adopted if the adopters recognize a benefit.

Key Benefits:

When standards development carefully considers the needs of the users, promotion of the final standard is simplified. Stakeholders readily see the advantages and ideally will promote the standard to others.

Statement:

Obtain project approvals from appropriate CDISC governing body(bodies); understand how the project fits within the technical roadmap and existing CDISC standards.

Rationale:

Resources are finite, therefore efforts must be coordinated and organized.

Key Benefits:

Adherence will:

  • Prevent duplication or overlap of effort.

  • Prevent development of conflicting standards.

  • Ensure the use of volunteer resources is optimized.

Statement:

The standards we produce are truly approved models. They are effective when adherence by all stakeholders produces comparable results.

Rationale:

To be effective, a standard must not be ambiguous.

Key Benefits:

Benefits of clear and unambiguous standards are:

  • Data are quickly understood by all parties when all parties understand CDISC standards.
  • Data are shared easily between any combinations of stakeholders who understand our products.
  • When users understand our products, data from any/all sources (e.g., academia, preclinical, clinical, post-marketing, patients) are easily combined and analyzed.

These benefits result in treatments that are:

  • developed more quickly, with less cost
  • less expensive in the marketplace
  • more effective and/or better tolerated
  • approved and marketed sooner
Statement:

Stakeholders require stable CDISC standards.

Rationale:

Change is time consuming and costly. CDISC standards should be mature upon release, meet stakeholder needs, and reflect consensus decision-making of the team to increase stability.

Key Benefits:

Stable standards will:

  • Increase value
  • Increase satisfaction
  • Improve integration of data
  • Decrease documentation and training overhead
Statement:

CDISC standards should include features that are necessary and easy to use.

Rationale:

Stakeholders need:

  • CDISC standards that support transfer and semantic interoperability of scientific content
  • CDISC standards documentation that are easily learned, understood, implemented, navigated, and satisfying to use
  • CDISC standards development processes that are easily learned, efficiently use volunteer time, ensure errors are minimized and/or recoverable, and satisfy participants
Key Benefits:

Standards that provide necessary features and are easy to use will

  • Increase value
  • Increase satisfaction
  • Improve support
Statement:

Ensure that all projects are defined as to deliver value to stakeholders.

Rationale:

CDISC is charged with developing standards that benefit all stakeholders.

Key Benefits:

By focusing on delivering value, we ensure that our products will facilitate the exchange of clinical data between stakeholders, speed the drug development process, and support delivery of effective drugs to patients.

Statement:

Preserve and adhere to established models and associated semantics.

Rationale:

Without conceptual integrity, there is no standard.

Key Benefits:

By enforcing conceptual integrity, we ensure consistency and stability of the standards, and deliver a "gold standard" for trial and healthcare data.

Statement:

Each project will define timing, end goals, and final deliverables, within an approved timeframe in a charter. Charters are approved by the appropriate governing body.

Rationale:

Because of the changing nature of clinical science and continued learning and harmonization, standards are developed in increments and versions to ensure quality, harmonization, and deliverability within a reasonable timeline.

Key Benefits:

Manageable workloads allow for quality and harmonization with other standards and deliverability.

Statement:

Position decision making at the lowest responsibility level.

Rationale:

Use as little governance as possible; burdensome governance stifles innovation and slows progress. Teams are empowered to address governance issues within the CDISC governance framework.

Key Benefits:

Right-size governance increases

  • Effectiveness, engagement, productivity
  • Team member satisfaction
Statement:

Standards governance should ensure alignment of initiatives with organizational goals to create value for implementers. CDISC standards governance should be responsive to the community, efficient, and focused on quality, and provide clear decision-making pathways.

Rationale:

Standards governance provides a framework for project management with clear decision-making and escalation pathways, including to create an environment for agile development.

Key Benefits:

Nimble governance results in

  • A transparent development process that ensures wide input and review.
Statement:

CDISC has an escalation policy that is used only when all avenues to resolve an issue within a team have been exhausted. The decision of the escalation committee is binding and will not be revisited unless significant additional information not previously considered comes to light.

Rationale:

Teams are empowered to resolve issues. However, occasional instances may arise where the team reaches an impasse. The escalation process is in place to mediate issues, as a last recourse.

Key Benefits:

Escalation process is necessary to:

  • Ensure the development process advances by breaking impasses
  • Support transparency and the Be Clear principle