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Review VTs prepared for coding

In the Medical Coding module, reviewing verbatim terms (VTs) prepared for coding is a crucial step to ensure accurate term assignments using standardized dictionaries like MedDRA and WHODrug. During this process, you can verify what VTs have been extracted from source data files and identify which terms still need to be assigned.

To review VTs prepared for coding

  1. In the Medical Coding application header, select the CODING tab.

    Accessing coding functionality
    Figure 1. Accessing coding functionality

  2. On the VT List page that opens, in the table, review a list of VTs prepared for coding, as explained in the following table.

    Reviewing VTs prepared for coding
    Figure 2. Reviewing VTs prepared for coding

    Tip

    For your convenience, above the table, you can select the Awaiting Manual Code or Completed filters to:

    • Awaiting Manual Code: to display only verbatim terms that have not yet been coded.

    • Completed: to show only the coded terms.

    Column

    Details

    ID

    A unique identifier for each VT entry. This ID allows easy reference to specific terms within the list.

    Verbatim Term

    The actual text or phrase as it appears in the source data. This is the original term provided upon initial data collection, which must be mapped to a standardized term in the coding dictionaries.

    Supplemental Variables

    Additional contextual information related to each verbatim term. These variables may include specific details from the source data, such as indication or route, which help provide context when coding the term.

    Coding Status

    Indicates the current progress of the coding for each VT. Possible statuses include:

    • Await Manual Code: the standardized dictionary term has not yet been assigned to a verbatim term and requires manual coding.

    • Completed: the standardized dictionary term has been successfully assigned to a verbatim term and coding is complete.

    Assigned Term

    The standardized term from either MedDRA or WHODrug dictionaries that has been assigned to the verbatim term. This term represents the medically or scientifically accepted equivalent of the original verbatim term.

    Path

    The hierarchical path in the coding dictionary (MedDRA or WHODrug) where the assigned term is located. This path helps you navigate through the dictionary's structure to find specific terms.

    For example, for the verbatim term "abnormal findings in urine (leucocyte +++, urine nitrite positive, wbc 40, mucous threads +, bacteria ++"), you might see the following in the Path column:

    • LLT: Nitrite urine

    • PT: Nitrite urine

    • SOC: Investigations

    This means that for this verbatim term, the coder assigned it to the following terms:

    • LLT (Lowest Level Term): Nitrite urine

    • PT (Preferred Term): Nitrite urine

    • HLT (High-Level Term): Urinalysis NEC

    • HLGT (High-Level Group Term): Renal and urinary tract investigations and urinalyses

    • SOC (System Organ Class): Investigations

    Dictionary

    Specifies which dictionary was used to assign the standardized term. Possible dictionaries include:

    • WHODrug: used for drug names and related terms.

    • MedDRA: used for medical conditions, adverse effects, and other clinical terms.

    Auto Match Type

    Indicates the result of an automatic matching process, if available. Possible types include:

    • Not Matched: no match was found in the dictionary, and the term requires manual coding.

    • Single Matched: one unique match was found in the dictionary, which can be used directly.

    • Multi Matched: multiple potential matches were found, and the coder must choose the correct one manually.

    Coded by

    The username of the person who assigned the standardized term to the verbatim term. This helps track who completed the coding for each entry.

    If the term was coded automatically, this field displays System.

    Coded Time

    The date and time when the coding was completed. This timestamp is useful for tracking coding activity.

  3. If you need more information about the verbatim term, in the Actions column, select Arrow-icon.jpg. Then, in the expanded Term Source table, review additional details about the selected VT as explained in the following table.

    Reviewing additional VT details
    Figure 3. Reviewing additional VT details

    Column

    Details

    Term Source

    Identifies the origin of the verbatim term, such as the eClinical EDC system or another source. This helps track where the term was initially recorded.

    Term

    Displays the raw, unprocessed verbatim term as it was extracted from the source data.

    During extraction, the CODING system always converts terms to lowercase in order to remove duplicates. Therefore, this column helps you understand what the term originally looked like before any processing or modification.

    Batch Number

    Refers to the coding batch in which the term was included.

    Original Term

    Shows the exact wording of the term as it was initially recorded in the source system before any splitting. It serves as a reference to the unaltered version of the term prior to the application of any split rules.

    Level

    Reflects the specific hierarchical layer within the coding structure—specified at the study setup phase in the Coding Admin module—that defines the depth of the term in the coding hierarchy.

    In dictionaries like MedDRA or WHODrug, terms are organized in levels, with each level corresponding to a different level in the hierarchy:

    • MedDRA example: levels may range from Preferred Term (PT) to higher levels such as System Organ Class (SOC).

    • WHODrug example: levels include Drug Name (base level), Ingredient (a higher level), or Substance Name (the most granular classification).

    So, basically, the Level value indicates the layer of the term being coded.

    Variable

    Represents the variable name from the source data file or from the EDC system that contains the verbatim term, such as AETERM, CMTRT, MHTERM, and others.

    Line

    Refers to the line number in the source file where the term was found. This detail assists in locating the term in its original dataset for verification or review.

    Form

    Indicates the form in which the term was recorded, such as a specific case report form (CRF). This helps you understand the data’s context within the study structure.

    Visit

    Specifies the visit name in the study at which the term was collected. This can help in understanding temporal aspects of the study data.

    Subject

    Refers to the participant identifier, linking the term to the specific subject in the study from whom the data was collected.

    Site

    Identifies the study site where the data was collected. This information can help in tracking study data across different locations.

    Study Name

    Indicates the name of the study in which the data was collected, helping to contextualize the term within a specific study framework.

    Action(s)

    This column helps you take actions on the term, such as querying the original source data for additional information or validation.

Now that you have reviewed the VTs that are matched or still pending, you can proceed to assign standardized terms from MedDRA or WHODrug dictionaries automatically or manually, ensuring consistent and accurate coding across the dataset.

See also
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 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.

In the clinical research industry, a software that is used to collect and store subject data in the clinical trial process in a permanent electronic form.

A collection of verbatim terms (VTs) grouped together for the purpose of medical coding. Each batch is created to streamline the coding process, allowing multiple VTs to be processed simultaneously.

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

An occurrence in a clinical trial in which the subject comes to a site to receive treatment, undergo some tests, or complete other required procedures.

A participant who is enrolled in a clinical trial and assigned to the site.

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.