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Coding review

During clinical trials, when reporting clinical information such as adverse events or serious adverse events, the reporter may use their own words and terms, known as verbatim terms, to describe the patient's condition, symptoms, and other relevant details. However, when creating an ICSR (Individual Case Safety Report), it is essential to convert these verbatim terms into standardized universal medical terms. This coding process ensures that the ICSR can undergo proper review and approval by regulatory bodies.

In PV, you can view and code all verbatim terms that have been entered in the ICSR (events, lab tests, medical histories, procedures, and so on) within a single page. This process is called the coding review. During the coding review, skilled professionals, such as medical coders or safety data specialists, meticulously analyze the reported information and apply appropriate medical codes based on international coding dictionaries such as MedDRA and WHODrug.

Perform coding review

In PV, you can view and code all verbatim terms entered in the ICSR (events, lab tests, medical histories, procedures, and so on) within a single page. This process is called the coding review. During the coding review, skilled professionals, such as medical coders or safety data specialists, meticulously analyze the reported information and apply appropriate medical codes based on international coding dictionaries, such as MedDRA and WHODrug.

To perform a coding review

  1. In the PV application header, select the ICSR tab.

  2. On the ICSR List page that opens, in the table, locate the ICSR record for which you want to perform a coding review. Then select its case number to open the details page in the new browser tab.

    Alternatively, from the Actions column next to your ICSR, select Edit pencil_icon.png to open the ICSR details in the same browser tab.

    Selecting to edit ICSR
    Figure 1. Selecting to edit ICSR

  3. On the ICSR form page that opens, from the toolbar, select Coding Review icon_coding_review.png.

    Accessing option for coding review
    Figure 2. Accessing option for coding review

  4. On the Coding Review page that opens, depending on which dictionary review you need to perform, select the MedDRA or WHODrug tab and perform the coding review as follows.

Once saved, the coding review is completed. The coding results are populated to the respective forms and their fields, such as the Products form for WHODrug coding and Events for MedDRA coding.

In this section:

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

An adverse event that results in death, is life-threatening, requires subject hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

A certified professional coder in the healthcare industry who is responsible for reviewing the patient's post-visit medical records and translating them into globally acceptable medical codes according to MedDRA, WHODrug, and other dictionaries.

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.

A safety service document that includes information required for reporting the adverse events and problems related to products and complaints filed by consumers with respect to any product.

An eClinical application that is intended for medical coding and managing elements of data collected during clinical trials to organize large amounts of information in a standardized way—according to WHODrug and MedDRA dictionaries. The application facilitates data analysis and ensures accuracy and consistency in reporting.

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