What it is
Medical Coding is the study-level workspace for standardizing verbatim clinical terms collected in CRFs against medical dictionaries such as MedDRA and WHODrug. It provides a centralized interface to review, search, assign codes, and manage reusable aliases for recurring terms.
Who uses it
| Role | Typical use |
|---|---|
| Medical Coder / Data Manager | Review and code verbatim terms from CRF data |
| Study Administrator | Configure dictionary versions and coding workflows |
| Sponsor | Review coding completeness for regulatory submissions |
Key capabilities
- Worklist of verbatim terms with coding status (Not Coded, Coded, Code Not Found, Locked)
- Dictionary search and preferred-term assignment against MedDRA, WHODrug
- Auto-coding — bulk match unresolved terms against configured dictionaries
- Alias management — reusable verbatim-to-code mappings for recurring terms
- Approval workflow — configurable review gate before codes are finalized
- Synonym management — map variant terms to the same preferred code
- Coding reports & export — download full coding data for regulatory review
Coding Workflow
| Step | Action | Role |
|---|---|---|
| 1 | Verbatim terms collected from CRF data | Data Entry / CRC |
| 2 | Auto-code attempts dictionary match | System (auto) |
| 3 | Coder reviews unmatched terms, searches codes | Medical Coder |
| 4 | Coder creates aliases for recurring terms | Medical Coder |
| 5 | Reviewer approves coded terms (if approval enabled) | Lead Coder / DM |
| 6 | Export coding report for sponsor review | Data Manager |
Batch Operations
- Auto Code — processes all unresolved terms in one click against the configured dictionary
- Export — download complete coding dataset (CSV/Excel) with all statuses and assigned codes
- Bulk alias creation — map multiple verbatim terms to codes simultaneously
Coding Status Lifecycle
Not Coded → (Auto-code or manual search) → Coded
Not Coded → (Search, no match found) → Code Not Found
Coded → (Approval, if required) → Locked
Code Not Found → (Alias created, re-search) → Coded