Module 13
Development Core Safety Information &
Development Core Data Sheets
Development Core Safety Information (DCSI) is an evolving set of vetted safety information that should finally become the centerpiece of safety information in submission labeling and that, at any time during clinical development, should be part of the information used as the basis for alerting study participants and investigators about identified potential risks. DCSI is accompanied by a larger set of information about safety-related observations in clinical and other studies that are not (yet) considered to represent the equivalent of adverse reactions/interactions for the purposes of labeling.
One of the purposes of clinical development is to generate a growing body of safety information that allows us to eventually define significant parts of the safety profile of a product/use, but also permits the refinement and correction of earlier conclusions about potential risks and corresponding advice on safe use. For defining which items deserve an alert, it is important to apply the same overall standards as in the postmarketing phase. Following the same standard does not yet, however, in itself ensure sufficient consistency in decision making over time. Additional measures may be necessary to control subjectivity-related variations.
Development Core Data Sheet (DCDS) is a generic term for a document that contains the complete evolving labeling for a product from a core labeling perspective. It may contain target and confirmed content/wording, local scenarios, references to ongoing and completed studies, comments, reminders, etc. Such a document can be a powerful, helpful tool for a development team and for management to monitor the progress of development in terms of resulting labeling information. Detailed target wording, drafted early enough based on draft study protocols, is also invaluable for verifying that the development program actually delivers the information needed for claims and for differentiating product features.
Curriculum topics of this module include:
- Definitions: CCSI, DCDS, Target Product Profile, Target Product Profile for use with FDA
- DCSI and CSI for a marketed product – same thresholds for including safety information?
- Measures to limit subjectivity in decision making across the development and marketing phase
- When to start with a DCDS to get maximum benefit
- Features of a DCDS
- Preparing for the revision of safety information at the end of the development program