Stage 5 · Toolkit 5.15
Medical Coding & Reconciliation
Manage MedDRA/WHO Drug coding, coding review, safety-clinical reconciliation, and coding queries.
What it helps control
Operational support
Helps teams establish the procedures, working records, trackers, and evidence needed for Medical Coding & Reconciliation.
How it helps your team
Connect trial execution, evidence, and decisions across sponsor, CRO, and site responsibilities.
Designed for
Clinical Operations, Clinical Development, Data Management, Biostatistics, Safety, Quality, and vendor oversight teams.
Included files
Know exactly what the toolkit contains
The file names below show what is included. File contents become available only after purchase.
Word documents
- Medical Coding SOP
- MedDRA Coding Review Checklist
- WHO Drug Coding Review Checklist
- Safety-Clinical Reconciliation Guide
- Coding Query Template
- Coding Decision Memo
Excel workbooks
- MedDRA Coding Tracker
- WHO Drug Coding Tracker
- SAE Reconciliation Tracker
- Coding Query Log
- Coding Evidence Tracker
Related toolkits
Continue within stage 5
Clinical Development Plan & Study Governance
Govern clinical development plans, studies, decisions, risks, and cross-functional actions.
5.2Protocol Development & Amendment Management
Develop, review, approve, amend, and control clinical protocols.
5.3Study Startup & Site Activation
Manage startup, essential documents, investigator packages, site activation, and green-light approval.