A verbatim is one free-text answer an investigator typed into the eCRF, waiting to be given a standardized term. Your job is to read each one, with the context around it, and assign the right code from the dictionary.
Everything you need is on this one screen. You never need access to the eCRF itself.
š Prerequisite: at least one mapping must exist in the study, otherwise the section reads Mappings need to be created to retrieve verbatims and there is nothing to work on. Ask your data manager.
On your role, Study add-ons > Medical Coding Coder. Access lets you see the verbatims and search the dictionary; Edit is what makes Apply code work. With Access alone the lookup and its results are visible but the button stays disabled.
Two more levels sit on the same permission: Review to approve or reject codes, and Export to export the coding.
Find your way around
Open your study, then Medical coding. Each mapping has its own tab, in alphabetical order, with the Mappings tab last. You land on the first mapping tab, not on the configuration.
Each tab offers two views:
Uncoded, your working queue, showing only what is left to do.
All, every verbatim whatever its status.
Both show the same columns: Verbatim, Code, Status, Subject, then one column per supporting item. Verbatim and Code stay visible while you scroll sideways. Rows are kept to a single line and truncated, so as many verbatims as possible fit on screen.
The Status column shows one of four statuses:
Uncoded (gray): no code is attached yet.
Coded (blue): at least one code is attached, waiting for review.
Approved (green): a reviewer has validated the code.
Rejected (orange): a reviewer has refused the code, which stays visible.
Clicking a verbatim opens a full-height side panel with the complete text, however long it is. The supporting items are listed there and open by default, because that is the context you need to choose a term. Subject, site, visit, form, item, mapping and dictionary sit in a collapsed section below.
š” Tip: four things about the queue that are easy to misread.
One verbatim per answer, never deduplicated. The same text reported by three subjects gives three verbatims, each with its own context, each coded on its own. That is deliberate.
Withdrawn and screen-failed subjects stay in the list. Their adverse events still have to be coded.
The list reflects the state at load time. A correction made in the eCRF while you were working appears after a reload or a tab switch.
Filters apply to the whole list. You can filter by code, status and subject, search by verbatim, and sort by code. Filters cover every verbatim of the tab, not only the page you are on, and they reset when you switch mapping tab.
Search the dictionary
The lookup sits next to the verbatim list and stays available whether or not a verbatim is selected. You can start from either end, depending on how you work.
Start from | What happens |
A verbatim | Click the verbatim text. Its details open and the search bar is pre-filled with that text, in the dictionary of its mapping. The search stays editable. |
The dictionary | Type in the lookup to find a term first, then pick the verbatim to attach it to. Only verbatims whose mapping uses that same dictionary can be selected. |
Searching MedDRA
MedDRA terms are organized in a hierarchy, from the Lowest Level Term (LLT) at the bottom up to the System Organ Class (SOC) at the top. You always pick an LLT, and every result is displayed with its full path, LLT to PT to HLT to HLGT to SOC, so you can check the branch before applying it.
The search matches LLTs only, so typing the name of a level above returns nothing. It works in contains mode, so partial words are enough and usually faster: ven recan proce finds Venous recanalization procedure.
Some terms sit under more than one branch of the hierarchy. All their paths are shown, color-coded blue for primary and white for secondary. The path you select is the one stored, and analyses group on it, so choose deliberately rather than taking the first row.
š” Tip: type a few partial words rather than the whole sentence. The search matches dictionary terms, not the investigator's phrasing, so severe headache since yesterday rarely matches anything, while headache does.
Apply a code
Selecting a result only pre-selects it. Nothing is attached to the verbatim until you click Apply code. You can select several results one after another, give each one an optional interpretation note explaining your choice, and apply them all in one go.
The status then turns Coded, and Datacapt stores the whole path along with the dictionary and its version, the mapping name, who coded it and when. The badge and the counts update straight away, and the row keeps its place in the list until the view is refreshed.
Removing a code is possible too. Removing the last one sends the verbatim back to Uncoded.
š” Tip: a verbatim can carry several codes, one per distinct medical concept. "Headache and vomiting" gets two. They all come from the mapping's dictionary and none takes precedence over the others. The verbatim stays a single row in the list whatever the number of codes.
If the answer is edited in the eCRF after it was coded, the verbatim goes back to Uncoded and its previous code stays visible in gray, for example Previous: Headache, so you can code it again quickly.
ā ļø Warning: three things the system will refuse, and why.
A verbatim with no text cannot be coded. It needs text before a term can be attached to it.
If the answer changed in the eCRF while you were working on it, the assignment is refused and the verbatim keeps its current status. Reload to see the new text, then code it again.
The same code cannot be applied twice to one verbatim, not even reached through a different path. The duplicate is blocked as you select it.
Separately, only current MedDRA terms can be selected. Terms MedDRA has retired are excluded from the search, so an obsolete code cannot be assigned by accident.
Assigning and removing a code are both traced in the audit trail, with the previous and the new value.
Approve or reject a code
Once a verbatim is Coded, a reviewer checks the code and approves or rejects it from the coding panel. The Approve, Reject and Clear code buttons appear depending on the current status.
Approve turns the verbatim Approved. Datacapt records who approved it and when, separately from who coded it.
Reject turns the verbatim Rejected. The code stays visible, so the coder sees what was refused.
Clear code removes the code.
Every status change is recorded in the audit trail, and the status counters of the tab update right away.
ā ļø Warning:
An approved code cannot be changed directly. Reject it first, then change it.
An uncoded verbatim cannot be approved.
A coder can approve their own codes if their role also has Review on Medical Coding Coder. If your process requires a second person, give Edit and Review to different roles.
Code and review several verbatims at once
Tick the checkboxes in the table to select several verbatims. A selection bar shows how many rows are selected, with Search code / Apply code(s), Approve, Reject and Clear code. Only the actions that work for every selected row are available.
There are two ways to apply a code to a selection:
Select the rows, then search for the code.
Or pick the code first, then select the rows.
An interpretation entered with the code is added to every selected row. A confirmation window appears before approving, rejecting, clearing, or replacing existing codes. Each verbatim still gets its own audit trail entry.
ā ļø Warning:
All or nothing. If one selected verbatim was changed by someone else in the meantime, or if saving fails, nothing is applied and an error message is shown.
Applying a code to Coded or Rejected verbatims replaces all their existing codes.
Select all only selects the rows of the current page. Changing a filter clears the selection.
Export your coding
Click Export at the top of the Medical coding page and choose the mapping(s) to export. You get a CSV file with:
the center, subject, visit, form and item
the verbatim and its coding status
the full MedDRA hierarchy, LLT to SOC, including the primary SOC
the interpretation, and who coded and reviewed it
There is one row per code. A verbatim with several codes appears on several rows, numbered with a Code index. An uncoded verbatim appears on one row with empty code columns. Each export is recorded in the audit trail, with the names of the exported mappings.
š” Tip:
The export contains every verbatim of the selected mappings. No other filter can be applied.
A verbatim sent back to Uncoded after an eCRF change is exported with its new text and no code, never with the previous code. A rejected verbatim is exported with its code.
What this version does not do yet
Blinded studies are out of scope for now.