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Medical Coding Role-Based SOP

# Medical Coding
Last updated: 04/14/2026

Purpose

Purpose​

This SOP defines role ownership and handoff for the Medical Coding lifecycle, from verbatim term intake through code assignment, review, and lock.

Use this page for operational alignment between Medical Coders, Lead Coders/Data Managers, and study administrators.

Scope​

  • Module: Medical Coding
  • Dictionaries: MedDRA, WHODrug, Custom dictionaries
  • Main roles: Medical Coder, Lead Coder / Data Manager, Study Administrator

Account Mapping by Role​

SOP RoleTypical Permissions
Medical Codermedicalcoding.view, medicalcoding.code, medicalcoding.alias.create
Lead Coder / Data ManagerAll Coder permissions + medicalcoding.approve, medicalcoding.reject, medicalcoding.unlock
Study Administratormedicalcoding.config — dictionary, approval, account setup

Role Matrix by Activity​

ActivityMedical CoderLead Coder / DMStudy Admin
View coding workspaceYesYesYes
Search & assign codesYesYes—
Run Auto CodeYesYes—
Create aliasesYesYes—
Edit aliases—Yes—
Approve coded terms—Yes—
Reject coded terms—Yes—
Unlock terms—Yes—
Export coding dataYesYesYes
Configure dictionaries——Yes
Configure approval settings——Yes
Manage BioPortal account——Yes

Step-by-Step SOP​

Step 1 — Initial Coding (Medical Coder)​

  1. Open Medical Coding from the top navigation bar
  2. Review the summary stats bar — note counts per status
  3. Click Auto code to process all unmatched terms against the configured dictionary
  4. Click the Code Not Found filter pill to review terms that need manual coding
  5. For each Code Not Found term:
    • Click Search code to open the dictionary search dialog
    • Search by keyword or browse the preferred name results
    • Select the appropriate code and assign it
  6. For recurring terms, create an alias in Alias Management for future auto-code efficiency

Expected output: All terms are either Coded or Code Not Found with documented reason.

Step 2 — Review & Approval (Lead Coder / Data Manager)​

When Approval Needed is Yes:

  1. Review coded terms in the main workspace
  2. For each coded term:
    • Verify the assigned code matches the verbatim term context (event, CRF, item)
    • Check for consistency — same verbatim term should map to same code across all occurrences
    • Click Approve to lock the code, or Reject to return to Not Coded
  3. Locked terms cannot be modified without unlocking

Expected output: All codes are reviewed and locked.

Step 3 — Coding Reconciliation (Lead Coder / Data Manager)​

Before database lock or interim analysis:

  1. Verify all terms are either Coded/Locked or Code Not Found (with documented reason)
  2. Review Code Not Found entries:
    • Can a dictionary update resolve these?
    • Should a custom dictionary entry be created?
  3. Run consistency check — filter by verbatim term and verify same code across all rows
  4. Export final coding report for sponsor review

Expected output: Coding complete and reconciled.

Step 4 — Dictionary Management (Study Administrator)​

  1. Configure BioPortal account (system default or study-specific)
  2. Set Approval Needed based on study requirements
  3. Configure Code with context for contextual matching
  4. Set up Custom Dictionaries if study-specific terminology is needed
  5. Import synonyms for common variant terms

Expected output: Dictionary configuration ready for production coding.

Quality Governance​

Coding Quality Metrics​

MetricTargetHow to Check
Auto-code hit rate> 80%Compare Auto-coded vs Total terms
Code Not Found rate< 5%Code Not Found / Total terms
First-pass approval rate> 90%Approved without rejection / Coded terms
Coding consistency100%Same verbatim → same code across all rows

Periodic Review​

  • Weekly: Review Code Not Found list for new alias opportunities
  • Monthly: Review coding progress against study timeline
  • Pre-lock: Full reconciliation with consistency check

Audit Requirements​

  • Every code assignment is recorded with user, timestamp, and dictionary
  • Approval/rejection actions include user and timestamp
  • Alias creation and modification are fully audited
  • Export records retain coding metadata for regulatory submissions
Medical CodingSOPCoderData ManagerMedDRA
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