This article covers the one-time steps to go through in getting a study setup for medical coding.
To do any medical coding outside of a study running in Clinical Studio you must have a dedicated study database that will be used to import the data. Here is how to create a new study.
Once there is a study, open the form builder and verify there is at least one code field and one term field on any of the forms that will be collecting the data.
If medical coding is being used as a stand-alone tool, you will need to create the forms that will collect this data and then complete the steps below.
As shown in the image below, the form must have at least two text fields. Of these two fields, one needs to be identified as a code and one as a term. These identifications are made by selecting the special Type property for each field, highlighted below.
Once you have identified at least ONE TERM and ONE CODE for one of the dictionaries, save the CRF in the Form Builder.
Typically the following forms contain the corresponding field properties:
Adverse Event form will contain one MedDRA term and one MedDRA code.
A Medications form contains one WHO Drug term (text field), one WHO Drug code (text field), one WHO Drug Description/Indication (memo field), and one WHO Drug Route.
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 and add a new configuration as shown below.
1) Choose the dictionary type
2) Select the form(s) where those dictionary terms are being collected. These are the forms/fields defined in the step described above.