Setting Up a Study To Support Medical Coding - When Data is Coming from TrialKit

This article covers the one-time steps to go through in getting a study setup for medical coding. This only applies to those who are collecting data within TrialKit EDC.

Most required setups are done in the form builder. This is where you will define which fields are collecting the events or drug names for MedDRA and WHO coding respectively.

Here is a list of the field types needed at a minimum for csCoder to function. The variable/field names can be whatever you choose:

  • Term (MedDRA or WHODrug) - Text field

  • Code (MedDRA or WHODrug) - Text field


  • Route (WHO) - Text or choice field

  • Indication (WHO) - Text or memo filed

  • Any Other reference variables - Text or Choice fields

For each of the fields above, identify the field property ‘Special type’ for which purpose each field serves (see image below). 

MedDRA and WHO fields cannot be mixed on the same form.

Once you have identified at least ONE TERM and ONE CODE for one of the dictionaries, save the CRF in the Form Builder. This will make it so data entered on that form displays within the TrialKit Coder tool.

Here are some common examples:

  • Adverse Event form will contain one MedDRA term and one MedDRA code

  • The medical History form will contain one MedDRA term and one MedDRA code.

  • Concomitant Medications form (similar to the image below) will contain one WHO Drug term (text field), one WHO Drug code (text field), one WHO Drug Description/Indication (memo field), and one WHO Drug Route


Optional suggestions:

  • The code field can be conditionally disabled to prevent the data entry person from accessing it. 

Do not hide the code field, as hiding inherently clears data.

  • Another field property, a special type, called "medcode field" can be mapped to any text or dropdown/choice field on the form. This will allow the Coder to pull that data into the medical coding tool for ease of reference by the person performing the coding. For example, the coder may want to know the dose of a medication or the severity of an event to aid in how they code each item.


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