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Batch management

Batch is a feature of the Medical Coding module designed to efficiently manage large volumes of verbatim terms (VTs) that need to be coded. By organizing terms into batches, this feature simplifies the coding process, allowing users to import, track, and code terms in structured groups (domains) for maximum efficiency. Batch management supports everything from creating new batches, reviewing coding progress, and maintaining quality control through customizable split rules and domain-specific configurations.

With Batch, you can manage data uploads from both files and the EDC system, perform essential actions like automatically splitting complex terms into distinct medical concepts based on preset rules, and monitor coding outcomes for seamless integration with dictionaries such as MedDRA or WHODrug. Use it to ensure consistent, high-quality coding across a broad array of data.

In this section, you will learn how to:

  • View a list of created batches: access the batch list to review all existing coding batches, including their details, statuses, and available actions.

  • View/Update the status of a coding batch: review or change the status of a batch as it progresses through different stages of the coding process.

  • Create a new coding batch: generate a batch of verbatim terms from either a file or the EDC system for coding purposes.

  • Edit coding batch details: modify the information related to a specific batch, such as its name or description.

  • Delete a coding batch: permanently remove coding batches that have been previously cancelled.

  • Review domains prepared for coding: view the list of domains that are set up and ready for the coding process.

  • Upload data files: upload files containing verbatim terms for coding.

  • Delete data files: remove data files that have been previously uploaded for a domain.

  • Review uploaded data: view the results of the initial data upload (both from files and the EDC system), helping you check which VTs have been uploaded and prepared for coding. Additionally, if the coding process has been started, the system shows how VTs have been matched with dictionaries like MedDRA or WHODrug.

  • Export uploaded data: export the data uploaded from either files or the EDC system, along with any completed coding results, if available. This helps you have a local copy of the uploaded data for further analysis, reporting, or record-keeping purposes.

  • View the export history: review the log of all previous exports from the domain for reference or auditing purposes.

  • Start coding: initiate the coding process for the verbatim terms present in a domain.

  • Cancel the coding process: stop an ongoing coding operation that has already been initiated.

  • Preprocess domains: begin the preprocessing phase for domains that require additional data handling before coding can begin.

  • View coding results: access and review coding results for all verbatim terms in a batch; initiate coding for uncoded terms; apply or manually adjust split rules; and unsplit verbatim terms if needed.

In this section:

In Pharmacovigilance, a common term used by the AE/SAE case reporter to describe the patient's condition, symptoms, and other details. In ICSR, the verbatim terms are coded (translated) into standardized preferred terms to meet the regulatory requirements.

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

Get to know all the possibilities of the app with the comprehensive EDC User Guide.

An internationally used set of terms relating to medical conditions, medicines, and medical devices created to assist regulators with sharing information.

A coding service that is used for the unified coding of drugs throughout the pharmaceutical industry. In order to achieve this, the service provides the WHODrug dictionary which is an international classification of medicines created by the WHO Program for International Drug Monitoring. The dictionary is managed by the Uppsala Monitoring Centre and contains drug code numbers, along with related information such as trade names, active ingredients, and additional information, such as marketing authorization, pharmaceutical forms, and strengths of the drugs.

For example, the WHODrug drug code for the substance Ibuprofen is 001092 01 001.

verbatim terms (VTs)