Medical Coding
Access to various functions within TrialKit Coder are based on permissions granted by the study Administrator.
After opening a coding project from the main project list, a table similar to below will be displayed. See below on how to perform coding.
Auto-Coding
In this example, medications are being coded using the WHO dictionary. Reference the numbered annotations for definitions of each item:
#1. Run auto-coding - Run the system autocoder on all records currently being filtered for in the table. Depending on the number of records, this can take a while, but functions in the background so users can continue with other work or log out and return.
Read more about the Autocode Algorithm
#2. Central Synonyms - List of local synonyms which need to apply to all coding projects and databases within the host account.
#3. Project Synonyms - List of local synonyms which only apply to the current coding project. The system will put priority on these over centralized synonyms. Read further about importing synonym lists below.
#4. Export Data - Exports data to CSV in a background job. To access exports, return to main screen and open the Jobs Manager. If the export is still processing, it may not appear right away.
#5 Data table - This defaults to a sorted order of patient ID followed by Record ID. Tap any column header to sort differently.
#6. Manual code search or access synonym lists. Read more in the next section below.
#7. Select ATC or SOC code: Tap the icon under the SOC/ATC column to select a specific SOC/ATC for the associated code. Only the Primary SOCs are assigned automatically by default
#8. Add a query to the record. When queries are added within TKCoder, it creates the same query on the term within TrialKit EDC. When site posts a response, it also displays within the coding project.
#9. Add as synonym - Quickly add the current verbatim term/code details to the local project synonym list to use on subsequent autocoding jobs.
#10. Copy/Paste - Tap to copy coding details for one record and then tap the same icon on another record to paste.
#11. Delete coding details - Clears all coding details for the current record.
#12. Review - Tap to mark the record reviewed. Only possible on coded records. This is not a required step, but can be helpful as a method of validation and preventing re-coding
#13. Mark all records reviewed - Tap the checkbox to mark all records currently being filtered as reviewed.
#14. Table configuration - Select which columns to display in the table for additional information. This is dependent on which data points have been made available if coding records from EDC. Some columns will always display by default.
#15. Filters - Search for specific terms in the list or use other following filters:
Patient ID
Uncoded records only
Terms changed after coding
Exclude Admin records (for studies running in integrated EDC)
Match status
#16. Return to list of coding projects
#17. Jump to top of list
Manual Coding
Tap the WHODrug or MedDRA icon under the Code column to manually code the corresponding record. A window similar to below will open pre-populated with the verbatim term to search. The term can be adjusted to manually search for another term. For those who prefer not to search by term, a manual code search for MedDRA coding has been added.
Search the dictionary (version specified at top of window)
Search synonym lists
Select a code to apply to the current record
Synonyms
Synonyms allow users to manually add specific terms which require pre-determined coding. Synonyms can be added quickly from the coding table by:
manually one-by-one
imported via CSV file in batches. Doing this prior to auto-coding will allow the autocoder to code those terms which otherwise would have required manual coding.
To import a CSV file of synonyms, create a file with the following headers:
For MedDRA coding: term, code
For WHO coding: term, code, indication, route, atccode
#3. Synonyms can be disabled to prevent auto-coder form using them, but still keep them from reference.
#4. Export synonym list
Synonym variables: If only a term/code are specified in the synonym, the system will use it for any record containing that term (exact match, non-case sensitive). If an ATC is specified with a route/indication, all elements must match in order for the synonym to be used by the auto-coder.
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