This article covers the one-time steps to go through in getting a study setup for medical coding. This only applies for those who are collecting data using Clinical Studio. For standalone coding (importing source data to be coded), read this article.
Most required setup happens 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 are a list of the field types needed at minimum for csCoder to function. The variable/field names can be whatever you choose:
Term (MedDRA and WHO) - Text
Code (MedDRA and WHO) - Text
Route (WHO) - dropdown or text
Indication (WHO) - text
For each of the fields above, identify the special type property 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.
Here are some common examples:
- Adverse Event form will contain one MedDRA term and one MedDRA code.
- 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.
- If preferred, 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, special type, called "medcode field" can be mapped to any text or dropdown/choice field on the form. This will allow the csCoder tool to pull that data into the medical coding tool for ease of viewing by the person performing the coding. For example, the coder may want to know the dose of a medication or severity of an event to aid in how they code each item.
The last step is to create coding configurations that correspond to the form where the text fields above were defined.
Open the Medical Coding application (csCoder) and add a new project tied to the form in the EDC.