Medical coding

Dictionaries, how terms are matched, your decisions, licences.

Upload a listing of concomitant medications, medical history or adverse events exported from any EDC (CSV, TXT or XLSX), choose a dictionary and get every distinct wording coded or put in front of you for a decision. No AI is used: the rules below are the whole method.

How a term is coded

1. Your own earlier decision for the same wording (case, punctuation and the ® sign are ignored).
2. An exact name in the dictionary: the term itself, an inclusion term, an INN or a trade name.
3. For drugs, the same after dropping dose, units and dosage form: “Аторис 20мг таб.” becomes “аторис”.

When a name leads to several codes (aspirin: B01AC06 or N02BA01, methotrexate: L01BA01 or L04AX03) the term is marked Several codes: pick by the indication. When it matches a group that may not be assigned (ICD-10-CM E11) you see the specific codes, the “unspecified / without complications” one first. Close spellings and terms with the same words are only suggested; nothing is applied without you.

Your decisions

Pick an option or type a code and press “Save my decisions”. The decision goes to your synonym list for that dictionary and is applied automatically next time. Every decision is written to the audit trail; you can remove one on the dictionary page.

Coding in a DM project

Inside a DM project open Medical coding in the project menu. Listings coded there are kept in the project: only the distinct wordings of the chosen column and their counts, never the file. Decisions belong to the whole team, are reused on every listing of the project coded with the same dictionary, and each one is written to the project audit trail. Data managers and the project administrator code and decide; viewers read. The menu shows how many terms of the latest listing still wait for a decision.

A dictionary you uploaded under your licence stays yours inside a project too: colleagues see the figures of listings coded with it, never its terms or codes. Built-in open dictionaries are shared by everyone.

Coding in YouEDC Capture

In a YouEDC Capture study a term is coded the moment the site saves the form. Open Medical coding in the study menu (the project administrator, data managers and the safety physician see it), pick the section (adverse events, medical history or medications) and bind a dictionary to the field with the verbatim term. Forms made from our templates have the codes filled in already: AE.AE_TERM, MH.MH_TERM, CM.CM_NAME. Data entered earlier is coded as soon as you bind.

What gives exactly one code is coded at once: the study team's decision for that wording, or an exact dictionary name. The rest waits for the coder under “Waiting for a decision”: pick a suggested option or type a code, and the decision applies to every value of the study with that wording, now and later. Close spellings are only suggested: “Hypoglicemia” may be hypo- or hyperglycaemia, so a person decides. Every code, its removal and the reason go to the patient's audit trail with the dictionary version.

When the site corrects the term, the old code is removed and the new term is coded again. Sites never see the codes. If coding fails while a form is saved, the site's data is saved all the same and the error goes to the Portal Owner's log.

A licensed dictionary (MedDRA, WHODrug, a full ATC) can be bound only by the person who uploaded it, who names the licence holder and its subscription number and confirms that the study team works on the holder's behalf. The whole study team then codes with it in this study; in other projects it stays unavailable. With MedDRA bound to adverse events, YouEDC Safety takes the preferred term of a serious event from the coding, and E2B names the MedDRA version. The team's decisions also count when SDTM is built.

Second level, queries, the organisation and a new version

A decision of the coder codes at once, but by default waits for a second person: a data manager, the project administrator or the safety physician. Open Medical coding → Second level: approve the decision or reject it with a reason. Nobody reviews their own decision. A rejected decision codes nothing any more, its values wait for the coder again, and the coder sees the reason. The review can be switched off there; switching it on or off is in the audit trail.

When a term is unclear (“bad feeling”, two events in one line), click Ask the site under it: a query with a ready text you can edit opens on the term field of every such form. The query number and status show in the queue. When the site changes the term, the old code goes and the new term is coded again.

When the study belongs to an organisation (YouEDC Sites), an approved decision can become the organisation's decision on the “Organisation” tab. Its other studies with a dictionary of the same kind then code the wording at once, in any version of the dictionary: the decision is kept by the code, and a study's own decision always comes first. The organisation's decisions never leave it; the organisation's admin or the person who made a decision can remove it.

When the licence holder has loaded a new version of the dictionary (MedDRA comes out in March and September), the dictionary card offers it. First the portal shows what changes: which terms get another code, which move under another PT or another primary SOC, which go back to the coder and which are coded for the first time. Only after you confirm does the study move to the new version: the team's decisions with current codes move along, every value is coded again, and the old code with the reason “dictionary version change” stays in the audit trail. YouEDC Safety cases already sent to the authority do not change.

The Figures tab shows: the share of terms coded at once when the form was saved, the median time from the term to the coder's code, how many wait and how many wait longer than three days, decisions at the second level, one wording with different codes (should be 0), queries per site, moves to new versions and YouEDC Safety cases whose PT differs from the study's coding (should be 0 by the database lock).

Dictionaries

• ICD-10-CM 2026 (USA, public domain): built in, about 47 000 codes. Only the most specific codes can be assigned; seventh-character extensions are not expanded yet.
• CTCAE 5.0 (NCI, public domain): built in, 837 adverse event terms with grades 1–5 and definitions, plus our own synonyms for British spellings and abbreviations (Anaemia, ALT increased). Term codes are the MedDRA codes NCI publishes in CTCAE; MedDRA itself is not included.
• UCUM units: built in, common clinical units with Russian and English spellings (ммоль/л, Г/л, 10^9/л, мм рт. ст.) and all units of the UCUM essence. Unit case matters: Г/л is 10*9/L, г/л is g/L; when case differs only, the match is marked.
• ICD-11 and LOINC are free, but their licences allow sharing only unchanged copies with attribution, and their sites need a download: load the WHO SimpleTabulation zip or the LOINC table (loinc.org, free account) in “Dictionaries”.
• ATC (WHO), demo extract: 50 common substances for trying the tool, with Russian and trade names. The WHO terms allow non-commercial use with a reference to the WHO Collaborating Centre for Drug Statistics Methodology; for real studies load the full index or a ГРЛС export.
• Loaded by you: the full ATC index, drug names → ATC from the State Register of Medicines (ГРЛС), ICD-10 from the Ministry of Health reference service (НСИ) or any code list, MedDRA (ASCII zip from MSSO) and WHODrug Global in the B3 format (a zip with the DD, DDA and INA files from UMC). WHODrug codes to the drug code; one name with codes that differ only in sequence number 2 is coded to the lowest of them. After the first upload compare the number of drugs with the release figures.

Licences. MedDRA and WHODrug need a subscription and their licences forbid passing them to anyone else, so the portal never ships them: an organisation that holds the licence loads its own files, and only the uploader sees them. The same rule applies to everything you load: tick the licence box only if you may use the dictionary here.

Data. The listing is read in memory and not stored. Upload files without names or other direct identifiers (subjects by study codes only). Only the wordings you decide on are kept, in your synonym list.