After opening a coding project, a table similar to below will be displayed. In this example, medications are being coded using the WHO dictionary. Reference the numbered annotations for definitions of each item:



1. Projects button - Return to main Projects page where each coding project is listed or new ones can be created.

2. User preferences, password reset.

3. Run auto-coding - Run the system autocoder on all records currently being filtered for. Depending on the number of records, this may take a couple minutes. This works in the background, so users can continue with other work or log out and return. Auto-coding will attempt to code any term that does not already have a code associated with it.

4.. Review All - Rather than tapping a review button (#8) for every record, this can be used to instantly tag everything on the list as reviewed. If a filter (#2) is applied, only the filtered items will get reviewed.

5. Central Synonyms - List of local synonyms which need to apply to all coding projects and databases within the host account.

6. 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.

7.  Export Data - Exports data to CSV

8. Fields - Select which fields you want displayed in the table. This is helpful for coders who wish to see different items in a single view. The options will include anything that was imported from the dataset (if using as a standalone system) or fields from the CRF in Clinical Studio where the data was collected.

9. Reload Grid - If the number of records being auto-coded at once is a high volume, use the Reload button to refresh the grid with newly coded records.

10. Filters - Filter the table, if desired, for the following:

  • Date range
  • Record/Subject ID
  • Verbatim (search) term
  • Record status (awaiting coding, awaiting review, reviewed, changed since review, etc)
  • Term changed since being coded
  • Exclude Admin Records - This is for integrated EDC coding only. Standalone coding will only contain "Admin" records

11. Verbatim term as entered in EDC or imported with data file.

12. Code currently selected for the corresponding record and dictionary button to access the dictionary

13. ATCs/SOCs - This is a list of all ATCs or SOCs (WHO or MedDRA respectively) associated with the selected code. Hovering over this presents an icon to edit which ATC/SOC is desired. Otherwise, all ATCs will be included in the export.

14. Add queries - These are queries intended for the coders. The most recent query comes out in the export. If the data is coming from Clinical Studio EDC, this query will not be part of the study queries.

15. Review Button - For reviewing a coded item. This depends on how the project is set up with its review levels.



Synonyms

Items 5 and 6 above allows you to manually add synonyms or import a CSV file containing a larger list of terms/codes known in advance. Doing this prior to auto-coding will allow the autocoder to code those items which otherwise would have required manual coding.

To add an item, simply fill in the fields requested. The dictionary can be opened from the page shown above if a code needs to be looked up.

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


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.