Medical Coding for Clinical Trials

Turn free text into codes inside your EDC

Datacapt Medical Coding maps the free-text answers collected in your eCRF to standardized MedDRA and WHODrug terms. Upload your dictionaries once, declare which items to code, and let coders work from a dedicated queue with a complete audit trail. No export, no external tool, no re-import.

MedDRA & WHODrug
Full audit trail
Coder workspace
Retroactive mappings
Medical coding
ONCO-22
Adverse events
Concomitant meds
Mappings
All
128
Uncoded
41
Verbatim
Code
Subject
Status
Headache since day 3
Headache
S-0031
Coded
Uncoded
Nausea and vomiting after dose
Nausea
+1
S-0031
Coded
Asthma got worse
Asthma aggravated
S-0026
Coded
Mild rash on left arm
S-0044
Uncoded
Elevated ALT at day 14
S-0009
Uncoded
Dizziness on standing
Dizziness postural
S-0018
Coded
Verbatim
Headache since day 3
Adverse events › Subsection 1
Onset
2026-08-03
Severity
Mild
Coding
MedDRA 28.1
LLT
10019211
Headache
Headache
PT
Headaches NEC
HLT
Headaches
HLGT
Nervous system disorders
SOC
LLT
10019213
Headache aggravated
LLT
10019216
Headache tension
Cancel
Apply code
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Upload. Map. Code.
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How it works

Three steps from free text to coded data

1
Upload the dictionary
Drop the MedDRA or WHODrug package in the global settings. Datacapt reads the version and the language from the file, and every study of the tenant can use it.
2
Map the items to code
In the study, pick the free-text item, up to 10 supporting items and the dictionary. Answers already collected join the queue at once.
3
Code the verbatims
Coders search the dictionary, check the full LLT path and apply one or several codes. Each action lands in the audit trail.
Dictionaries

Upload your dictionaries once, use them in every study

Dictionaries live in the global settings of your tenant. Upload the MedDRA or WHODrug package exactly as the provider delivers it, enter its password, and every study can map against it.

Version and language read from the package, no manual entry

Several versions active at once, for studies that span dictionary releases

Deprecate a version to stop offering it in new mappings; codes already assigned never change

One dictionary per language and version, with a status that tells you when it is ready

Settings
Global
Users
Roles
Audit trails
Dictionaries
API
Dictionaries
+ Upload dictionary
Name
Lang.
Version
Status
MedDRA English 28.1
en
28.1
Active
MedDRA French 28.1
fr
28.1
Active
MedDRA English 27.1
en
27.1
Deprecated
MedDRA Spanish 28.1
es
28.1
Active
WHODrug Global B3
en
2025-09
Active
WHODrug Global B3
en
2026-03
Active
Uploading
Mappings

Declare what gets coded, and against which dictionary

A mapping ties one free-text item to one dictionary, with up to 10 supporting items that give the coder context. Until an item is mapped, nothing is collected and nothing can be coded.

Works on free-text questions, including items inside repeated measures

Supporting items of any type from the same subsection, shown to the coder and never coded

Retroactive: answers already collected join the coder’s queue, even on a study running for years

eCRF changes flagged on the mapping: broken in red, modified in yellow, moved items unaffected

Medical coding
ONCO-22
Adverse events
Concomitant meds
Mappings
New mapping
Name
Coded item
Supporting items
Dictionary
Adverse events
AETERM
AESTDTC
AESEV
AEOUT
MedDRA EN 28.1
Concomitant meds
CMTRT
CMDOSE
CMINDC
WHODrug B3
Modified
Medical history
MHTERM
MHSTDTC
MedDRA FR 28.1
Prior meds
PMTRT
PMSTDTC
PMENDTC
WHODrug B3
Procedures
PRTRT
PRSTDTC
PRINDC
MedDRA EN 28.1
New mapping
Item to code
AETERM · Adverse event term
free text
Supporting items (up to 10)
AESTDTC
AESEV
AEOUT
Dictionary
MedDRA English 28.1
Active
Cancel
Create mapping
Mapping created · 142 existing answers added to the queue
Coder workspace

A queue built for coders, no eCRF access required

Every answer collected on a mapped item lands in the study’s Medical coding page as a verbatim, with the context the coder needs and nothing else.

One tab per mapping, with an Uncoded working queue and an All view

Verbatim, code, status, subject and one column per supporting item, with verbatim and code pinned while you scroll

A side panel opens the full text and its supporting items in one click

Coders see verbatims only and never open the eCRF

Medical coding
ONCO-22
Adverse events
Concomitant meds
Medical history
Mappings
Uncoded
5
All
10
Verbatim
Code
Subject
Status
Onset
Severity
Stomach pain
S-0006
Uncoded
2026-08-01
Moderate
Headache
S-0006
Uncoded
2026-08-11
Mild
Severe headache since yesterday
S-0001
Uncoded
2026-08-03
Severe
Cough at night
S-0005
Uncoded
Mild
Asthma got worse
Asthma aggravated
S-0026
Coded
2026-07-22
Moderate
Rash on both arms
S-0011
Uncoded
2026-08-14
Mild
Dictionary lookup

Find the right LLT in a few keystrokes

Search from a verbatim or from the dictionary. Partial words are enough: “ven recan proce” finds “Venous recanalization procedure”, and retired terms stay out of the results.

Full path shown before you apply: LLT, PT, HLT, HLGT and SOC

Terms on several branches show every path, primary in blue; the path you pick is the path stored

Several codes per verbatim, one per medical concept, each with an optional interpretation note

Apply code stores the path, the dictionary version, the mapping, the coder and the time

Verbatim
Vein reopening procedure, left leg
Subject
S-0019
Date
2026-07-14
Status
Uncoded
Coding
MedDRA 28.1 · English
LLT
10072318
Venous recanalization procedure
(Surg)
Venous recanalisation
PT
Vascular therapeutic procedures NEC
HLT
Vascular therapeutic procedures
HLGT
Surgical and medical procedures
SOC
Interpretation: recanalization of the left femoral vein, per investigator note
LLT
10072318
Venous recanalization procedure
(Vasc)
LLT
10064919
Venous reconstruction
(Surg)
1 code selected
Cancel
Apply code
Audit trail and permissions

Every dictionary, mapping and code, traced

Three permission sets separate who manages dictionaries, who builds mappings and who codes. Each action lands in the audit trail with the user and the timestamp.

Dictionaries: Access to view, Edit to upload, deprecate or delete

Mappings: Access to view, Edit to create or delete, with a warning before any deletion

Coder: Access to read verbatims, Edit to search a dictionary and assign codes

Safeguards: a dictionary used by a mapping cannot be deleted, only deprecated

Roles
Data manager
Permission
Access
Edit
Medical coding dictionaries
Medical coding mappings
Medical coding coder
Audit trail
Medical coding
Code applied: Headache (LLT 10019211), MedDRA 28.1
j.martin · 2026-09-02 14:12 · mapping Adverse events
Mapping created: Adverse events (AETERM)
a.dupont · 2026-09-01 09:40 · 142 existing answers queued
Dictionary deprecated: MedDRA English 27.1
l.tran · 2026-08-28 16:05 · codes already assigned unchanged

Ready to Code Smarter?

Book a 30-minute demo and see dictionaries, mappings and the coder workspace running on your own protocol.

Frequently asked questions

Still have a question? Talk to our team.

What is medical coding in clinical trials?

Medical coding translates the free-text answers collected in the eCRF, the verbatims, into the standardized terms of a medical dictionary: MedDRA for adverse events and medical history, WHODrug for medications. The same event reported in different words then maps to a single code, which keeps safety reporting and analysis consistent.

Is medical coding built into the Datacapt EDC?

Yes. Dictionaries, mappings and the coder workspace live inside Datacapt. You upload the dictionary once, declare which eCRF items to code, and coders work from their own queue without opening the eCRF. No export, no external tool, no re-import.

Which coding dictionaries does Datacapt support?

Datacapt supports MedDRA and WHODrug, in any language and version. You need your own dictionary licence: Datacapt ships no dictionary content. Several versions can stay active at once, and you can deprecate a version without changing the codes already assigned.

Can I code adverse events and medications in the same study?

Yes. Each mapping ties one free-text item to one dictionary, so adverse events point to MedDRA and concomitant medications to WHODrug in the same study. Coders get one tab per mapping.

Can I code answers that were collected before coding was set up?

Yes. Mappings are retroactive. The moment you create one, every answer already collected on that item joins the coder queue, even on a study that has been open for years.

What happens when a new dictionary version is released?

You upload the new version next to the current one. Several versions stay active at the same time, and deprecating an old version keeps it out of new mappings without touching any code already assigned.

Do coders need access to the eCRF?

No. Coders work from the study's Medical coding page: verbatim, code, status, subject and the supporting items declared in the mapping. They never open the eCRF and they never change collected data.

Can one verbatim receive several codes?

Yes. A coder applies one code per medical concept, each with an optional interpretation note. Datacapt stores the full path (LLT, PT, HLT, HLGT, SOC) with the dictionary version, the mapping, the coder and the timestamp.

Is the module validated and compliant?

Yes. Datacapt Medical Coding runs on the same validated platform as the EDC, in line with 21 CFR Part 11, ICH-GCP and GDPR. Every dictionary upload, mapping and code assignment is traced with who did it and when. Validation documentation is available on request.

What do customers say about Datacapt ?

Find out why 200+ companies place their trust in the Datacapt Platform to manage their clinical trials.

CRO
Thanks to Datacapt, we cut our site training time by four, reduced setup timelines by 40%, and boosted both our processes and responsiveness.
Chloé Arnous
Clinical Project Manager
Patient research
I was able to configure, test, and launch the survey in just four days, making real-time adjustments and validating the solution without relying on technical intermediaries.
Eva Menard
Founder
Biotech
Datacapt surpassed our expectations thanks to its user-friendly interface and the availability of its team. It made form design and data collection remarkably intuitive, resulting in significant time savings and enhanced accuracy.
Axel Boulet
Data Steward
Medical devices
By trusting Datacapt, we quickly achieved a level of regulatory compliance we couldn’t have reached on our own, while gaining autonomy in our clinical studies.
Samuel Lerman
Co-founder
CRO
When I first opened Datacapt, I instantly got the feeling this was the next generation of eClinical platform.
Jakub Poplawski
Global Dir. Business
Academic research
Datacapt is a reliable and educational tool, designed to support researchers at every stage of their clinical study.
Prof. Laurent Clavel
Head of the Palliative Care Dpt
CRO
Beyond the tool, we found a reliable partner capable of evolving with us and understanding our specific needs.
Véronique Saunier
Clinical Investigations Coordinator
Digital health
The Datacapt solution allows you to optimize your studies management, with quality and safety assurance.
Louis Létinier
Co-founder
CRO
Thanks to Datacapt, we cut our site training time by four, reduced setup timelines by 40%, and boosted both our processes and responsiveness.
Chloé Arnous
Clinical Project Manager
Patient research
I was able to configure, test, and launch the survey in just four days, making real-time adjustments and validating the solution without relying on technical intermediaries.
Eva Menard
Founder
Biotech
Datacapt surpassed our expectations thanks to its user-friendly interface and the availability of its team. It made form design and data collection remarkably intuitive, resulting in significant time savings and enhanced accuracy.
Axel Boulet
Data Steward
Medical devices
By trusting Datacapt, we quickly achieved a level of regulatory compliance we couldn’t have reached on our own, while gaining autonomy in our clinical studies.
Samuel Lerman
Co-founder
CRO
When I first opened Datacapt, I instantly got the feeling this was the next generation of eClinical platform.
Jakub Poplawski
Global Dir. Business
Academic research
Datacapt is a reliable and educational tool, designed to support researchers at every stage of their clinical study.
Prof. Laurent Clavel
Head of the Palliative Care Dpt
CRO
Beyond the tool, we found a reliable partner capable of evolving with us and understanding our specific needs.
Véronique Saunier
Clinical Investigations Coordinator
Digital health
The Datacapt solution allows you to optimize your studies management, with quality and safety assurance.
Louis Létinier
Co-founder
How working with us starts
Three steps from this page to a study open for inclusion.
1
Book the discovery call
Thirty minutes with a clinical data specialist, your protocol on screen.
2
Take the product tour
One hour in the platform. We run your study through the modules you would use.
3
Go live
We set up your team, then your study opens for inclusion.

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