In the early days of MedDRA coding it was hard to find a health care professional who had any experience coding MedDRA. Many companies had to adopt a hybrid approach to coding. An example of this would have been when a Data Manager performed the coding and the oversight would be carried out by an HCP after the fact.
In today’s world, coding teams are often organized into three models:
- The first model is a Centralized Coding Group. In this model, team members code both clinical trials as well as safety data and are usually dedicated to dictionary management. This helps to reduce SAE reconciliation issues. This model also allows for coding consistency across all therapeutic areas.
- The second model type is a de-centralized team. In this model, the primary coders are not necessarily HCP and may have other roles to perform. This model produces less consistency between Clinical and Safety data. Implementing QC checks and coding review needs to be considered with this model.
- The third model is a CRO model. In this model, there is flexible resourcing. CRO’s may not necessarily be familiar with the coding conventions of all clients. QC and quality review is usually the responsibility of the sponsor and requires some duplication of efforts.
Deciding how to organize your coding team can be a major decision. Consider your best practices and what model works best in your organization. It is beneficial, however, to remain nimble and adaptable to new team organizational structure should your needs change.