Coding software is often one of the most overlooked clinical technologies. Coders are often subjected to using simplistic coding tools that were built in house many years ago. Coding tools built into a piece of OTS (off the shelf) software designed for another purpose, or sometimes your favorite product retires before you. This can result in fragmented and non-efficient coding environments where coders must know many different coding tools and manage multiple implementations of the same dictionary or a need to move to a new software when you happy with your current software.
Workflow is very crucial when it comes to coding. It is important to think about your current workflow when choosing a new system. Is the workflow you are using right now one you chose or was it dictated by your current system? Are there things you would change or do you need a new system that is flexible enough to match your current workflow? This is also a great time look at your processes, SOPs, and integrations to see where you can gain efficiencies, free up resources and improve quality. Are you tired of manually loading your terms or maybe you want to add an integration? Are you a CRO that requires multiple workflows for different clients? Does your Safety group have a different workflow then your clinical group?
If any of these cases are true, you will want to carefully look at the configurability of the coding systems you are considering. Does the software have robust workflow functionality? Everyone in the coding process should be considered when you switch systems as it is a good time to fix any issues with your current process. At eclipse we not only work with our own coding system but other systems as well. We recommend choosing a solid stand-alone coding system and a company that understands the importance of process to help you implement it.
Dictionaries are the heart of any coding system and that makes dictionary management one of the most crucial functionalities of the coding system. You will want to look for a coding system that is flexible enough to support all of your dictionaries, standard or custom. The system should offer easy and intuitive dictionary loading that can be performed by your dictionary administrator. In the event you do not have a dictionary administrator, you will want to ensure the system vendor can support this activity or they can provide a SAAS offering that will meet your needs. The system should also support multiple active dictionary versions and languages. This is especially important for CROs or if you have long running studies that you will want to keep on a certain dictionary version. When it comes time to move your study over to a new dictionary version, the coding system should provide tools that will help you determine the impact on your coded terms ahead of the move and provide recommendations for any items that are impacted.
Configurability and functionality are also key factors in a coding system. The most popular features we rely on everyday help us perform our job efficiently and accurately. Things like robust customizable coding algorithms, custom synonym lists and custom stop word lists are a must to maximize the effectiveness of your auto encoder. An easy to use web interface, custom workflow and coding propagation all enhance the manual coding experience. Solid administration tools and interfaces, dictionary management, easy configuration and a robust integration layer will help drive down cost of maintenance and free up IT resources. All of the above are important things to look for in any coding system and it is also important to choose a vender that will listen to your needs and work with you to grow the software.
Having a single coding system to handle all of your coding needs helps reduce cost by simplifying dictionary maintenance, reducing training and reducing IT resources. When all coding is performed in a central software it becomes important that the software has proper Permissions and Access Rights. In a complex environment it is necessary to ensure that users are only able to access the coding terms and features that they are allowed access. You may need to restrict who can access certain verbatim based data source for example a safety system vs an EDC system or trial A vs trial B. You may also need to limit access based on workflow step, for example you may wish to have coder and an approver setup. You will also need to be able to restrict based on feature; only some users may be able to create / manage synonyms, propagate codes or run the auto-encoder. It also important to have the ability to setup manager roles so the coding manager can distribute the terms to various coders.
Coding systems often serve as the location where you house all of your coded data. They hold key information such as which verbatim terms have already been loaded into the coding system, which terms have been coded and identification keys to determine if the source system has modified the verbatim or its supporting data. All of this is important to ensure duplicate data is not loaded and coded and modified data gets recoded as needed. In some circumstances you may be able to keep your existing data in your current coding system until your study ends, but for long running studies this can add costs such as dictionary maintenance, hardware and software maintenance, IT resources and of course the drain of using multiple systems. It is important to exam what data you are currently coding and how long you will need to support this data. Once you have determined this you will want to choose a vender that is able to help you decide which data to migrate and is able to migrate the data in an efficient and cost-friendly manner.
There are many factors in choosing a new coding system and we talked about quite a few of them today. It is also important to select a vender that will be a good partner. In addition to providing a modern clean coding system they should be able to support you when it comes to business process, maintenance and services. You should also look for a vendor that is actively supporting and adding features to their coding system.