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YouEDC Capture

Answer lists and dictionaries

One list for many fields, dependent lists, МКБ-10 and other dictionaries in a field.

An answer list holds answer options written once per study and used by any number of fields. In a registry, “Severity”, “Yes / no / unknown” or “Region” appear in a dozen forms. With a list you type them once and they never drift apart: correct the list, and every field gets the new options.

One list, many fields · a registry example Severity SEVERITY 1 Mild 2 Moderate 3 Severe 4 Life-threatening AE severity Form “Adverse event” Severity of condition Form “Hospitalisation” Exacerbation severity Form “Exacerbation” “4 · Life-threatening” added to the list: it appeared in all three fields at once, with an audit record for each.

How to create a list

  1. Open the eCRF builder and click Answer lists.
  2. Add a ready-made list (sex, yes / no / unknown, severity, ECOG status, smoking, federal district) or click New list.
  3. Write the options one per line: CODE|Text. The code goes to the export, the investigator sees the text. You can paste columns from Excel after replacing the tabs with “|”.
  4. In the properties of a “Single choice”, “Drop-down list” or “Multiple choice” field, choose the list under Where the options come from.

The “Severity” list as an example:

1|Mild
2|Moderate
3|Severe

What happens when a list changes

Every field that uses it gets the new options at once. Each changed field goes to the audit trail, and the next eCRF version shows the change in the version comparison. The text of an option can be corrected at any time. An option that at least one patient already has cannot be removed: the system names the field and the code. A list that any field uses cannot be deleted either.

Dependent lists

A dependent list points to a parent list: each of its lines ends with the code of a parent option, CODE|Text|PARENT CODE. For example, a “Region” list depends on the ready-made “Federal district” list:

77|Moscow|CFD
50|Moscow region|CFD
78|Saint Petersburg|NWFD

In the Region field, set Show only the options of the answer in to the “Federal district” field of the same form. The investigator sees only the regions of the chosen district, and the server refuses a region of another district even when it comes from an import file.

A dependent list and a dictionary · what the investigator sees Federal district Central North-Western Volga Region (depends on the district) 77 Moscow 50 Moscow region 78 Saint Petersburg Main diagnosis (a “From a dictionary” field, ICD-10) diabetes without compl E11.9 Type 2 diabetes without complications E10.9 Type 1 diabetes without complications The code E11.9 is saved; the patient page, the casebook and the export show the diagnosis next to it.

The “From a dictionary” field: ICD-10 and others

When there are thousands of options, as in ICD-10, nobody writes a list: the field takes them from a dictionary. The investigator types a code or words of the name, picks a term, and the code is saved. The patient page, the casebook and the export show the text next to the code, and the export’s data dictionary names the dictionary the codes come from.

  1. Download МКБ-10 (the Russian ICD-10) from the Ministry of Health reference service НСИ (dictionary 1.2.643.5.1.13.13.11.1005) as CSV or Excel.
  2. Upload the file in Medical coding → Dictionaries as a code list: the columns MKB_CODE, MKB_NAME, ID and ID_PARENT are recognised, rows that are no longer valid are skipped.
  3. Add a field of the type From a dictionary to the form and choose the uploaded dictionary. Confirm that the team and the sites may read it.

Only a final code can be chosen (for example, E11.9). A group such as E11 is not saved: the system asks for a more specific code. A “From a dictionary” field cannot be put in a form the patient fills in.

Licences

An uploaded dictionary is visible only to the person who uploaded it. The study team and the sites read it only through a field for which its uploader confirmed the right. So licensed dictionaries the team uses on the licence holder’s behalf (MedDRA, a full ATC index) are not offered for such a field. МКБ-10 is not shipped with YouEDC, because WHO holds the copyright on ICD. The built-in open dictionaries (ICD-10-CM, CTCAE, UCUM units) can be chosen right away.