Medical coding

Medical coding is the mapping of free text (adverse events, concomitant therapy) to a dictionary code. In X7 Insight, coding is a status axis of a value (not required → awaiting code → coded), and it is dictionary-agnostic: the platform does not interpret MedDRA/WHODrug — the actual code (LLT/PT) is held by the coder module or an external process, while the core records the status and the audit.

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The coder's inbox: verbatim terms awaiting a code, marking them coded, and the recode tab

The coder’s queue

The Coding navigation item (the Medical Coder role, the data.coding.write permission) opens the queue of terms:

• Awaiting code — free text has been entered, but there is no code yet. A term also returns here automatically if a coordinator edits the value of an already-coded field (recode): the code must be reconsidered.
• Coded — control and recoding; “Return to queue” removes the mark.

A term opens in its form context via the ↗ link — with its neighbouring fields and queries.

1. not requiredfield requires coding
2. awaiting codecode assigned
3. coded
   • value editawaiting code

A value's coding axis. Editing an already-coded value returns the term to the queue for recoding.

1. Open Coding in the study section and pick a site (or all).

2. Check the term against the form context (the ↗ link), assign a code in the external dictionary tool or the coder module.

3. Click Coded — the status and the author are recorded in the audit trail.

Note

A field enters the queue only if the “requires coding” (requires_coding) flag is set on it in the CRF design. Empty values are not coded.

Caution

Uncoded terms (uncoded) block the hard lock of the database (hard lock) at study closeout — the coder’s queue must be empty before the Database Lock.

Export boundary

The core’s final package carries the coding axis (coded/uncoded) but not the assigned codes themselves: dictionary terms (MedDRA PT/LLT, WHODrug) live with the coding module or an external process and are exported by its means. When planning the sponsor package, include the code export from that tool — otherwise the datasets have to be assembled from two places.

Inbox

The Coding section of the shared “Tasks” inbox shows terms awaiting a code across all studies where you hold the data.coding.write permission.