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Medical Coding Workspace

# Run Study
Last updated: 04/14/2026

Use the Medical Coding app to review, search, and assign standardized medical codes to verbatim terms collected in CRFs, and manage reusable aliases for recurring terms.

info

For the business definition of Medical Coding, see Medical Coding in Getting Started.

URL patterns: https://[instance]/study/[studyId]/apps/medical-coding and .../alias-management

Typical workflow​

  1. Open the study and navigate to Medical Coding in the top navigation bar.
  2. Review the summary stats bar to understand the current coding status across all entries.
  3. Use the filter pills (Total, Not Coded, Code Not Found) to focus on records that need attention.
  4. For each unresolved row, click Search code to open the code search dialog, find the correct preferred term, and assign it.
  5. Use Auto code to automatically match all remaining unresolved terms against the configured dictionary.
  6. Optionally, navigate to Alias Management to review or create reusable verbatim-to-code mappings.
  7. To review source data verification alongside coding, use All Tasks → SDV in the top navigation to open the SDV workspace.

Accessing Medical Coding​

From within the study, Medical Coding appears in the top navigation bar alongside other apps. You can also use the All Tasks dropdown (available in the top navigation bar) to jump to Medical Coding or to navigate to related features such as SDV.

Medical Coding main page showing the coding table and summary stats bar

In the navigation bar:

  • MEDICAL CODING — Main verbatim coding workspace (active tab shown above)
  • ALIAS MANAGEMENT — Reusable verbatim-to-code mapping store
  • ALL TASKS — Dropdown showing all study app areas; SDV is listed under Data Compliance

Medical Coding workspace (observed)​

Summary stats and filter pills​

At the top of the Medical Coding page, a row of filter pills shows the current coding status across all entries. Each pill is clickable and filters the table to that status.

Medical Coding toolbar showing summary stats, Auto code button, and Export as button

PillDescription
TotalAll verbatim terms in the study (active/selected by default)
CodedTerms that have been successfully assigned a medical code
Not CodedTerms that have not yet been coded
Code Not FoundTerms where a search was performed but no matching code was found
LockedTerms that are locked and cannot be edited

Top-level controls visible on the screen:

  • Search — Filter the table by verbatim term, subject ID, event, CRF, or item name
  • Auto code — Automatically attempt to match all unresolved terms against the configured dictionary
  • Export as — Download the coding data including all verbatim terms and their current coding status

Coding table​

The main table lists all verbatim terms submitted across subjects. In the observed study, the table shows the following columns:

Medical Coding table showing columns: Verbatim term, Dictionary, Status, Subject ID, Event, CRF, Item, Medical codes, Action

ColumnDescription
Verbatim termThe raw text entered by the data entry user on the CRF
DictionaryThe medical dictionary used for coding (e.g., MedDRA)
StatusCurrent coding status: Not Coded, Coded, Code Not Found, or Locked
Subject IDThe ID of the subject who submitted the term (clickable)
EventThe study event associated with the CRF entry
CRFThe name of the CRF form where the term was entered
ItemThe specific CRF item (field) that captured the term
Medical codesThe assigned medical code(s), once coded
ActionAvailable row-level actions (see below)

Row actions​

ActionAvailable whenDescription
Search codeStatus is Not Coded or Code Not FoundOpens the code search dialog to find and assign a medical code
View in CRFAlwaysOpens the source CRF entry for the subject to view the data in context

Search Code dialog​

Clicking Search code on a row opens a dialog where you can:

  1. Search by keyword — the verbatim term is pre-filled in the search box
  2. Browse the Preferred Name results returned from the configured dictionary
  3. Select a result to assign it as the medical code for the term

Auto code​

Click Auto code in the toolbar to automatically attempt to match all unresolved verbatim terms against the configured dictionary. Terms with exact or high-confidence matches are coded automatically. Terms that cannot be matched are marked as Code Not Found.

All Tasks — navigating to SDV​

The All Tasks dropdown in the top navigation bar provides access to all study workspaces from within Medical Coding, including the SDV app.

All Tasks dropdown open, showing SDV under Data Compliance section

To navigate to SDV from Medical Coding:

  1. Click All Tasks in the top navigation bar.
  2. Under Data Compliance, click SDV.
  3. The SDV workspace opens, showing View by CRF and View by Subject tabs.

SDV and Medical Coding work together — verbatim terms coded in Medical Coding are often linked to CRFs that are also subject to source data verification.

Alias Management workspace (observed)​

Click Alias Management in the top navigation bar to open the alias store.

Alias Management page showing the alias table columns

Alias Management stores mappings between verbatim terms and their preferred medical codes. Once an alias is created, future occurrences of the same verbatim term can be auto-coded using the saved mapping.

The alias table shows the following columns:

ColumnDescription
Verbatim termThe raw term as entered in the CRF
External DictionaryThe external medical dictionary the alias maps to (e.g., MedDRA)
Custom DictionaryA custom/internal dictionary mapping, if applicable
Created OnDate the alias was created
Created ByUser who created the alias
Last Updated OnDate the alias was last modified
Preferred nameThe standardized preferred term assigned to this verbatim term
URLReference URL for the assigned code in the dictionary
ActionEdit or delete the alias

Top-level controls on the Alias Management page:

  • Search — Filter aliases by verbatim term or preferred name
  • Export as — Download the full alias list

Note: Auto code is not available on the Alias Management page. Use it from the main Medical Coding workspace.

Relationship to configuration​

What dictionaries are available, how auto-coding behaves, and which study accounts are linked are all driven by settings under Medical Coding configuration. If expected dictionaries do not appear or auto-code does not produce results, verify that the dictionary and account are configured correctly.

  • Medical Coding configuration — Dictionary setup, auto-code settings, and account configuration
  • SDV Events — Source data verification organized by study event; accessible from Medical Coding via All Tasks → SDV

Batch Auto-Code Operations​

For studies with large volumes of verbatim terms, batch operations help accelerate coding.

Auto Code All​

  1. Click Auto code in the toolbar
  2. The system attempts to match all Not Coded terms against the configured dictionary
  3. Terms with exact matches are coded automatically
  4. High-confidence fuzzy matches are coded if Approval Needed is No
  5. Unmatched terms are marked as Code Not Found
  6. Review the results by clicking the Code Not Found filter pill

Auto Code Best Practices​

  • Run auto-code after each data entry batch to keep the coding queue manageable
  • Review Code Not Found terms after each auto-code run — these need manual search
  • Create aliases for recurring unmatched terms to improve future auto-code hit rates
  • If Approval Needed is Yes, auto-coded terms remain in a pending-review state

Approval Workflow​

When Approval Needed is set to Yes in configuration, coded terms require review before finalization.

Approval Steps​

  1. Coder performs initial coding (manual search or auto-code)
  2. Coded term enters pending approval state
  3. Reviewer (Lead Coder or Data Manager) reviews each coded term
  4. Reviewer can Approve (term becomes Locked) or Reject (term returns to Not Coded)
  5. Locked terms cannot be modified without unlocking

Approval Roles​

ActionMedical CoderLead Coder / Reviewer
Search & assign codesYesYes
Auto-codeYesYes
Create aliasesYesYes
Approve coded terms—Yes
Reject coded terms—Yes
Unlock terms—Yes
Export coding dataYesYes

Coding Reconciliation​

Before database lock or interim analysis, perform coding reconciliation:

  1. Verify all terms are either Coded or Code Not Found (with documented reason)
  2. Review all Code Not Found entries — are any dictionary updates needed?
  3. Confirm all aliases are current and valid
  4. Run consistency check: same verbatim term → same code across all occurrences
  5. Export final coding report for sponsor review

Consistency Check​

  • Filter by Verbatim term to see all occurrences of the same term
  • Verify the same code is assigned to all occurrences
  • If different codes are assigned, determine whether context (different event/CRF) justifies the difference

Export & Reports​

Export Coding Data​

  1. Click Export as in the toolbar
  2. Choose format: CSV or Excel
  3. Select scope: current filter or all records
  4. Click Export

The export includes: verbatim term, dictionary, status, subject ID, event, CRF, item, assigned codes, coder, coding date.

Coding Progress Report​

Use the summary stats bar to track coding progress:

  • Total — all verbatim terms in the study
  • Coded + Locked — complete
  • Not Coded — pending
  • Code Not Found — requires manual intervention

Target: all terms either Coded or documented as Code Not Found before database lock.

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