Define Once. Code Consistently.
Coding quality starts with clear rules. We work with your team to design and document the coding conventions that eliminate ambiguity, align coders, and keep your data consistent across studies.
- MedDRA and WHODrug conventions tailored to your organization
- Covers all relevant data domains and coding scenarios
- Reduces queries, rework, and coder-to-coder variation
- Ready to use as a standalone document or embedded in your SOPs
Without a Convention, Every Coder Decides for Themselves
When coding rules are unwritten or inconsistent, the same verbatim gets coded differently depending on who is coding, when, and for which study. That variation creates query cycles, reconciliation work, and regulatory risk.
A well-written coding convention removes judgment calls from the coding process and replaces them with documented, agreed-upon rules—so coders spend time coding, not deliberating.
- Eliminates coder-to-coder variation on ambiguous verbatims
- Reduces query volume by clarifying edge cases in advance
- Speeds up onboarding for new coders and CROs
- Supports consistent cross-study analysis and signal detection
- Demonstrates procedural rigor during regulatory inspections
- Provides a shared reference for sponsor, CRO, and vendor alignment
What We Build With You
We deliver a structured coding convention document—written in plain language, organized by data domain, and tailored to the dictionaries and workflows your organization uses.
Not a generic template. A document your coders will actually use.
- General coding principles and decision hierarchy
- Domain-specific rules: AE, SAE, medical history, concomitant medications, indications
- MedDRA-specific guidance: level of coding, combination terms, vague or unspecified terms
- WHODrug-specific guidance: B3 vs C3, incomplete drug names, combination products
- Rules for raising queries vs. coding with best available information
- Synonym list and "Do Not Code" list integration guidance
- Version-controlled document formatted for SOP integration
Have an existing convention that needs a review or update?
Typical Convention Topics by Dictionary
The right convention rules depend on which dictionaries you use and which data domains are in scope. Here is what we typically address for each.
MedDRA
- Primary SOC assignment when multiple SOCs apply
- Coding combination verbatims: split or most specific term
- Handling unspecified, vague, or colloquial terms
- Medical history: current vs. resolved conditions
- Coding indications, diagnoses, and cause of death
- How to handle abbreviations, misspellings, and lay language
- When to use "Investigations" vs. clinical findings SOC
WHODrug
- Handling incomplete or partial drug names
- Coding combination drug products
- When to code to investigational or company-specific drugs
- ATC classification level preferences
- Handling brand name vs. generic name discrepancies
- Prior vs. concomitant medication rules
How We Work
Convention development is a collaborative process. We bring structure and drafting expertise; you bring the context about your studies, therapeutic areas, and existing practices. Together, we produce something coders can rely on from day one.
- Discovery: structured workshop to understand your data domains, systems, and known pain points
- Draft: we produce a first draft covering general principles and dictionary-specific rules
- Review: review cycles with your coding leads and QA team to refine and align
- Finalize: version-controlled convention document, ready for SOP integration
- Training: optional walkthrough session with your coders to introduce the conventions
- Maintenance: periodic reviews when dictionaries update or new study types are added
Ready to Define Your Coding Standards?
Tell us about your coding environment and the gaps you want to close—we will outline how to get a convention in place quickly.