Guiding Principles

• Statement: Terminology development process should ensure that the principles within CDISC models and guides are upheld.

• Rationale: Domain models and guides influence and inform terminology team decision making. CDISC terminology is developed based on the meaning and use of domains and variables, as outlined in implementation and user guides. These guides give each terminology team a starter set of scoping rules in order to identify appropriate terms for a given codelist.

• Key benefits: Maintains integrity of the appropriate implementation of the domain model and decreases the chance of overloading variable meaning. This also leads to consistency within and across CDISC terminology products. Supports the consistent representation of data within variables.

• Actions you can take: Terminology team members should understand the meaning and use of CDISC models, domains, variables and guides.

Statement: CDISC terminology analysis should inform the development of new domains, variables, and guides.  

Rationale: When new domains, guides, or variables are being developed, it is best practice to engage terminology early in the process, as terminology considerations may influence standards development.

Key benefits: Ensures that new domains, guides or examples are consistently and accurately generated according to standards development timelines.

Actions you can take: Terminology team members should be aware of new standards development and ensure terminology representation on these development teams. Terminology team members should communicate concerns to the standards development team leads.

• Statement: Be mindful of the impact of terminology changes to the user community.

• Rationale: Some terminology changes are costly or disruptive for end users, though some change is necessary as the science changes. Additionally, terms and codelists are shared across multiple terminology teams within CDISC.
   
   
• Key benefits: Minimizes unnecessary or unproductive changes to terminology.

• Actions you can take: Terminology teams should assess the value added for any proposed change to existing controlled terminology and be mindful of the cost of change implementation and version management to end users. Terminology teams need to identify other CDISC stakeholders that a change may affect and recognize the additional impact for a cross-team change. The team will solicit feedback from additional teams before a final decision is made.
   
   

• Statement: Terminology changes should be communicated, and stakeholder input taken into consideration before publication of production terminology.

• Rationale: Dictionary management is time and resource intensive. It is helpful to communicate intended changes to all stakeholders well in advance to support timely implementation of  terminology changes.
  
  
• Key Benefits: Early and transparent communication between stakeholders and terminology teams during the entire terminology development lifecycle ensures stability of published terminology, thus facilitating adoption and consistent implementation.
  
  
• Actions you can take: Terminology team decisions will be available in team working documents located on the CDISC wiki. Webinars will be given to summarize all changes being proposed within each package. All terminology products will go through public review. Stakeholders can comment on all terminology in public review and all stakeholder comments are visible to the public. Denied requests are publicly accessible with reason for rejection.

• Statement: Consider terminology reuse before new development.

• Rationale: Terminology development is resource intensive. The definition of a term should be context independent. Therefore re-use of existing CDISC terminology and other terminologies from standards development organizations is appropriate and encouraged.

• Key benefits: Reuse of existing terminology, where applicable and appropriate, is less resource intensive and decreases development costs. Reuse promotes semantic alignment, regardless of use or context. This also ensures we avoid duplication and in turn makes terminology development more efficient.

• Actions you can take: Refer to the latest version of CDISC terminology whenever requesting or creating new terminology. Consider previously developed source terms and definitions from regulatory authorities and standards development organizations.

• Statement: Make consistent decisions when developing terminology and consider precedent-setting aspects before making final decisions.

• Rationale: Consistent decision making during the terminology process leads to consistent usage and granularity of terms.

• Key benefits: Consistency within and across CDISC codelists and terminology products ensures the production of high quality terminology. Also ensures that decisions made by different teams are consistent by alignment to a set of shared rules and principles.

• Actions you can take: Follow published terminology principles, rules and best practices. Assess whether additional rule sets are necessary and develop these as needed. Transform identified precedents into published rules. Be mindful of setting additional precedents.

• Statement: Proactively meet the emerging needs of CDISC teams and users.

• Rationale: A prospective and responsive approach to regulatory and data exchange needs facilitates consistent data and earlier standards adoption.

• Key Benefits: Early development of terminology resources enhances consistency in terminology use across different stakeholders. Proactive terminology management enhances quality across the data lifecycle.

• Actions you can take:
  Be informed of standards development activities within CDISC to identify and support terminology development opportunities. Create and maintain supplemental terminology products (e.g., rule sets, value level metadata, denied request dispositions, etc.). Correct errors promptly.