Module 10
Core Labeling and Controlled Terminology
Typically, a CCDS/CCSI is not maintained solely as a reference document for reporting purposes but is intended to:
Direct what risk information is included in local labeling
Provide affiliates the very least with a good model for how to present that information effectively
Authors will, therefore, choose terms that precisely and effectively communicate a medical concept and are widely understood, while at the same time – at least for adverse reactions, and where appropriate – using MedDRA as standard terminology. The use of MedDRA standard terms in a CCDS/CCSI helps affiliates correctly translate core labeling content into local labeling.
Frequently, CCDS/CCSI authors will have to pick one of MedDRA's Preferred Terms (PTs) or Lowest Level Terms (LLTs) as superordinate concept for an entire group of PTs, in order to present adverse reactions at a level of granularity that is appropriate for risk communication. MedDRA's High Level Terms and High Level Group Terms are usually too broad to serve as meaningful superordinate concepts for risk communication in labeling (except, for example, when used as subsection titles). But even if done with great care to ensure the superordinate concept exactly matches the scope of the subconcepts, term grouping can render subconcepts unlisted/unlabeled for regulatory reporting reasons (while not rendering them "noncommunicated" for risk-communication purposes). The same issue exists in local labeling. The conflict between the needs of good risk communication and reporting cannot be resolved by simply applying regulatory reporting rules to govern labeling content granularity.
Curriculum topics of this module include:
- How terms function in risk communication
- Review of key points of the MSSO's "MedDRA and Product Labeling: 'Best Practices' Recommendations"
- Principles of good term grouping
- Risk communication issues associated with changeover of labeled terms from other terminologies to MedDRA
- Term grouping and calculating/estimating incidence rates and adverse reaction probabilities