Much of the data collected during a clinical trial is collected at different sites, by different physicians, in different time zones, and increasingly in different cultures. This situation, as well as other factors, leads to inconsistencies and variation in the data that is entered into fields on the Case Report Form (CRF).
One of the greatest challenges in achieving clean data is to control the consistency of terminology throughout the study.
The solution for the varying fields of data within a clinical study is a process referred to as medical coding. The data originally entered is compared and matched with standard libraries or dictionaries and updated with clinical terminology that is uniform and acceptable to regulatory agencies. Coding can be done automatically (computer-aided), manually or a combination of the two. The more consistent the clinical data, the more reliable the data analysis, the integrity of the final clinical study report, and the eventual marketing authorization submission to regulatory authorities.
DZS/ClinPlus has developed the most flexible clinical coding solution in the industry, which is guaranteed to meet all your adverse events (AE) and drug coding needs. ClinPlus® Coding is the industry's most powerful coding tool allowing users to meet all of their coding challenges with unmatched speed and accuracy. With over 15 years of coding experience behind us, our latest release represents a complete re-engineering of the original product. It leverages leading-edge Microsoft .NET, SQL technology and the latest changes in dictionary formats and evolving industry requirements, yet still retains the reliability and flexibility ClinPlus users have come to expect.
Multiple Dictionary Support
ClinPlus® Coding supports virtually any dictionary including MedDRA, WHO Drug (B-1, B-2 and Enhanced formats), COSTART, WHOart as well as custom dictionaries and multiple versions of the same dictionary. The country and ingredient information, found in the WHO Drug Dictionary Enhanced, is utilized during both the auto and manual coding function.
The product supports a single deployment in either an SQL Server or SAS environment and allows coding of SQL Server and SAS data. Regardless of the configuration, installation and project set-up training requires significantly less time than competitive products.
A task-oriented, user-friendly interface (GUI)
Our totally new, task-oriented user interface is extremely intuitive, facilitates quick navigation to required tasks and promotes more rapid user familiarity. if you get stuck, there's a comprehensive context-sensitive online help just a click away.
Achieve outstanding hit rates during auto-coding
ClinPlus® Coding runs at unprecedented speed. Thousands of records are auto-coded in less than a minute and details of each coding job are permanently maintained.
Phrase Substitution Support puts you in total control
ClinPlus® Coding's phrase substitution features dramatically increases your hit rates. Phrase substitution lists allow you to take full control for substitution, removal or modification of single words, phrases or any information contained within the qualifiers. For example, you can substitute blood pressure for bp or substitute the suffix s for ing, effectively changing words like feels to feeling.
You can also use phrase substitution to remove entire words or phrases. For instance you can remove the words really and bad so terms like really bad headache will match headache. Qualifiers such as parentheses may also be used to remove extraneous information. For example, fever (101.5) would match fever. All matches that are possible are presented as suggestions in ranked order for your selection.
Maintain Consistency and Control
One of the biggest challenges when coding is maintaining consistency but still retaining the ability to control your coding decisions. With ClinPlus® Coding you can do both easily because the system "learns" as you code. After auto-coding, you can load all un-coded records and leverage various search options to help you find the right match quickly and easily. You can also choose to perpetuate your decision to other records with the same verbatim text. Additionally, you can choose to automatically add your coding decisions to a thesaurus for use in future coding sessions.
Maintain terms and medications not found in your dictionary
ClinPlus® Coding comes with a supplemental thesaurus that maintains AE terms or medication names that either are not found in the main dictionary, or are used to override dictionary coding. Additional terms/meds may be added during manual coding sessions with administrator approval.
Multiple SOC (System Organ Class) or ATC (Anatomical Therapeutic Class) codes
When you encounter codes that link to multiple SOC or ATC codes, you can choose these yourself or let the system assign the dictionary default. Or, when auto-coding, you can set the system to pre-select the default or primary path as defined in the dictionary
Stay compliant by keeping track of all decisions
With ClinPlus® Coding, every code assignment and method is recorded in an audit trail that provides access to the coding history on each record, along with summary information for each auto-coding job. All of these coding decisions may be reviewed and eventually marked as approved. The audit trail will record the details of every approval.
Produce a variety of custom reports
The report interface allows you to produce a variety of the pre-defined coding reports such as All Terms, Un-coded Terms, Coded Terms, Multiple Body System/ATC, Frequency Counts or Coding History. Simply subset your data and tailor any number of reports by choosing the variables to include, rearranging the columns, changing the sort order or pagination, and then simply save as a user-defined report. The system is also flexible enough that you can create your own custom reports from scratch.