Medical coding turns the free text your investigators type into the eCRF, the verbatims, into the standardized terms of a medical dictionary. The same event reported in three different wordings, or in three languages, then arrives at analysis as one value.
Your job is to declare which answers must be coded and against which dictionary. Until you do, nothing is collected and your coder has an empty queue.
đ Prerequisite: a dictionary already uploaded and Active on your platform, and Study add-ons > Medical Coding Mappings on your role. Access lets you see the mappings, Edit lets you create and delete them.
What can be coded
Only free-text questions: the reported term of an adverse event, a medical history entry, the name of a concomitant medication.
A free-text item inside a repeated measure can be coded, and this is the usual case. Each occurrence produces its own verbatim, with its own context.
A free-text item inside a matrix cannot be coded in this version.
Any other question type cannot be coded. It can still be attached to a mapping as a supporting item, to give the coder context.
Create a mapping
A mapping is what sends a verbatim to the coder. Each one is one item to code, up to 10 optional supporting items, against one dictionary.
đ ď¸ Step by step guide
In your study, go to Medical coding, open the Mappings tab, then select New Mapping.
Select the item to code, by browsing the eCRF tree or searching on its variable or question title.
Add up to 10 supporting items if your coder will need context.
Choose the dictionary.
Check the mapping name, which is computed for you, and edit it if your team has its own convention.
Field | Required | What to enter |
Item to code | Yes | The free-text question whose answers must be coded. |
Supporting items | No | Up to 10 other items from the same subsection, of any type, files included. Shown to the coder as context, never coded themselves. An item cannot be its own supporting item, and ePRO or eConsent items are never offered. |
Dictionary | Yes | Any dictionary marked Active. The picker is not MedDRA specific: other dictionary types appear here as soon as they exist. |
Mapping name | Computed | Built from the item variable, the supporting item variables and the dictionary, for example |
Creating a mapping is retroactive. The answers already collected on that item are pulled into the coder's queue, not only the ones that arrive afterwards. On a large study they take a moment to appear and the list shows that it is still generating. Nothing is lost and nothing is duplicated.
đĄ Tip: one mapping per item and per dictionary. The same item can be mapped twice only if the second mapping uses a different dictionary. Creation is all or nothing: if pulling in the existing answers fails, no mapping is created and no half-filled queue is left behind.
The mappings table
Every mapping in the study is listed with its name, the item variable, the supporting item variables and the dictionary. Click a row to open its details in a side panel, or delete it from the row.
â ď¸ Warning: a mapping cannot be edited, and deleting one deletes every code assigned through it. A warning modal tells you before you confirm. Deletion stays possible long after verbatims have been coded, and there is no way back. To change a mapping, delete it and create a new one, knowing the codes go with it.
Creation and deletion are both traced in the platform audit trail, under the event type Mapping.
What happens when the eCRF changes
An eCRF keeps evolving after go-live, and a mapping points at one precise item. When that item changes, the mapping is flagged so you can see what happened and what was lost.
Change in the eCRF | Flag | What happens |
The item is deleted, or its type is no longer free text | Broken mapping, red | Collection stops. The verbatims collected so far and their codes are deleted. Remove the mapping, then create a new one on the replacement item if there is one. |
The question title changes, the variable is renamed, or a supporting item is modified or deleted | Modified mapping, yellow | Collection continues and the codes already assigned are kept. Nothing is required of you, and coding goes on. |
The item is moved elsewhere in the eCRF | None | No impact at all. |
The flag sits on the mapping row, with a tooltip explaining what changed and what to do next. A flag never clears itself: it stays for as long as the mapping exists. The only action offered on a flagged mapping is Remove mapping.
â ď¸ Warning: hide a coded question rather than delete it. When a question that has been coded should no longer appear in the eCRF, ask your study manager to hide it. Deleting it, or changing its type, destroys the verbatims and every code assigned to them, and they cannot be recovered. Hiding keeps the coding work intact.
A Modified mapping also blocks its item: no new mapping can be created on it until the flagged one is removed, and removing it deletes its verbatims and codes too.
đđť Next step
Code verbatims against a dictionary
Upload and manage medical dictionaries
What medical coding is, and how it works in Datacapt