Controlled Terminology Overview
Coding decisions for adverse events and medications is part science and part art. There is room for interpretation left up to the person deciding on which preferred term or hierarchical System Organ Class (SOC) is associated with the verbatim term. This may differ slightly between projects with different drugs and indications. The difference in coding decisions is compounded when there is more than one person making the decision. This is even further exacerbated when the individuals work in different organizations such as various CROs with different operating procedures. There are many variables contributing to different coding decisions which create a challenge for the data manager who needs to pull all these coding decisions into one coherent and consistent set of coded data for analysis and submission. This paper will describe an approach to manage and reconcile these differences referred to as “ThesQA” or Thesaurus Quality Assurance. The workflow of this methodology is shown here:
The first and pivotal step in the work flow is to be able to manage all the dictionaries centrally by registering them. This is also referred to as “Setup”. Setup gives you the ability to track change control and manage the metadata pertaining to each dictionary. Once you have identified all the versions of dictionaries and their related coding decisions and store the information centrally, you can start to work towards reviewing and reconciling their differences. The goal is to manage all the changes while maintaining change control that takes place during updates.
Dictionary Setup and Management
The first step in managing your dictionary is to manage the metadata pertaining to each set of data. The metadata is stored in a SAS dataset so that it can be easily updated by SAS tools. An example view of the data would look like:
The SAS dataset named DICTDB, which stands for dictionary database, does not contain the actual values of the dictionary, but rather it captures information about each thesaurus dictionary to be managed. The following steps describe the approach towards setting up the dictionaries.
complete paper at: "Effective Ways to Manage Thesaurus Dictionaries", AE Coding Software and Coding Dictionary.