Cathy Hult, Director, Data Management, PROMETRIKA, LLC
Coder is a Medidata application designed for mapping verbatim terms (e.g., adverse events [AE], concomitant medications [CM], and medical history [MH]) to specific terms in industry standard dictionaries (i.e., MedDRA, WHODrug). Coder is integrated with the Medidata Rave EDC system, allowing terms entered in Rave EDC to be directly transmitted into the Coder application for processing, and then transmitted back into Rave once coding is complete.
PROMETRIKA, LLC was accredited in the Coder platform in March 2017. In the short time we have been using it, the flexible Medidata coder platform has already proven efficient in assigning codes to verbatim terms in real time when integrated with Rave studies. The top three advantages that we have experienced are:
- The Coder application includes a number of configurable parameters to define the application roles, coding workflow, and dictionary and synonym list management. We have created a Coder manual that provides the procedural steps for implementing the Coder application and configured the Coder to meet a specific workflow as it relates to review and approval of coding assignments. For example, synonym lists are easily configured when setting up Coder, and easily implemented and executed during the coding process. Some workflows require that coding decisions be approved first prior to being sent back to Rave. If no approval is required, the coding decision is sent back to Rave immediately.
- The verbatim term is transmitted from Rave to Coder following entry of data by the study site. The integration allows for real time auto-coding, manual coding, creation of synonyms and synonym lists, and posting of queries directly to the site to clarify a verbatim term, reclassify a term (recode), perform coding consistency review, and generate coding consistency listings. The coding assignments are transmitted back into Rave once coding is complete and reviewed. They are then available for use in deliverables such as safety review meetings and Data Monitoring Committee meetings. There is no longer a need to merge coding back into the AE, CM, and MH raw datasets.
- The coding consistency review can be performed on an ongoing basis, allowing faster feedback regarding coding assignments. In our current workflow, we have a Clinical Data Manager (CDM), experienced with medical coding, assigned as a “Synonym Administrator.” The “Synonym Administrator” is responsible for the review and approval of the synonym lists. This set-up adds an extra level of quality control of coded terms, and ensures that similar codes have been assigned to the correct lower level term and synonyms, and that coding is completed according to study-specific coding guidelines. The Synonym Administrator can approve the coded term or ask the CDM coder to recode the term or reject the verbatim term, which is sent back to the site for remediation. The site has to review and approve new synonyms before they become operational.
Using synonym lists increases the auto-coding “hit rate” as more synonyms are present in the synonym list. The CDM and the sponsor can generate AE, MH, or CM coding consistency listings at any time using the Rave data listings. However, special formatting of the coding consistency listings may be needed, and may require SAS programming.
We also investigated using the Coder in a stand-alone capacity to manage coding of AEs, MH, and CMs for studies from non-Rave EDCs. This activity is necessary when working on a study in which the CDM’s responsibility is to perform up-versioning of verbatim terms for an NDA submission. Up-versioning of terms is usually performed on an upload of one cumulative file. The Coder as a stand-alone product supports the workflow needed to complete the up-versioning of verbatim terms, despite the multiple steps required to import and export the data to and from the coder.
PROMETRIKA’s positive experiences with Medidata Coder, as part of the EDC system or stand-alone, has resulted in more efficient coding and review for our data managers.