Laboratory reference ranges

Laboratory reference ranges is a module that keeps the reference ranges of the study laboratories and uses them to flag a lab value right in the data-entry form: L — below range, H — above range, within range — a quiet caption “range 117–155 g/L”. The flag is a hint to the investigator, not a data change: it does not block entry, and the clinical significance of a deviation is assessed by a person, in the form fields the design provides.

The reference list opens from Lab ranges in the “Setup” layer of the study menu — for those who maintain the ranges. Everyone else sees the ranges as the L/H flag in data entry, without a menu item.

Setup in five steps

1. Laboratories. On the Laboratories tab add a laboratory and tick the sites it serves. A subject’s values are compared with the ranges of the laboratory of their site.

2. Parameters and ranges. The fastest way is Import from Excel: upload the laboratory’s range table (CSV or XLSX). The module creates missing laboratories and parameters itself. Ranges can also be added and edited by hand on the Ranges tab.

3. Mapping to fields. On the Parameters tab tick, for every parameter, the eCRF fields its value is entered into. If there is no lab form yet, Build a lab form… creates one in the draft version from a parameter group — one field per parameter with its unit — and maps the parameters at once (this is an action of the design author).

4. Sex and age. On the Settings tab point to the sex field (and its codes as stored) and the source of age: the date of birth or an age field. The sample date field sets the date on which the range in effect is chosen and the age is computed; without it — the visit date of the form. If a site sends samples to several laboratories, point to the laboratory field on the form.

5. Checklist. The Checklist tab is the lab-module checklist. While it has findings, some values get no flag.

Range file format

The first row holds headers; column order does not matter; names are recognised in English and Russian.

Column	Required	Example
Laboratory	yes	INVITRO-MSK
Parameter code	yes	HGB
Group		Haematology
Parameter name		Haemoglobin
Unit		g/L
Sex		male, female, any
Age min, Age max		18, 44
Low, High		117, 155
Description		fasting
Complete		yes
Valid from, Valid to		2026-01-01, 31.12.2026

Age is in whole years and bounds are inclusive: a “18–44” range covers both 18 and 44; the next one starts at 45. An empty age or period bound means no limit.

A range has a validity period, and a value is judged by the range in effect on the sample date. Changing the bounds, unit, sex or age does not overwrite the range: it creates a new revision from the “valid from” date (today by default); the previous one closes the day before, so flags of past samples do not change retroactively. A range is never deleted at all — it is retired from effect: the previous one remains in the audit trail, and it can be used to reconstruct why a value was once flagged. Ranges created before periods existed are open-ended. A file row with the same laboratory, parameter, sex and age revises the range in effect; a new one adds a range. All file errors are reported at once with row numbers, and nothing is written if there is any error.

The easiest path is an export

Export to Excel produces a file in the same format (plus sheets of laboratories, parameters and the checklist). Edit it and upload it back.

What the checklist verifies

• every site is linked to a laboratory;
• parameters exist and are mapped to numeric eCRF fields of the published version;
• the subject sex and age fields are set;
• a range’s unit matches the parameter’s unit;
• a range has at least one bound, and the low bound does not exceed the high one;
• ranges of one parameter at one laboratory do not overlap (an “any sex” range overlaps every sex-specific range of the same age) when their validity periods meet;
• the age span of study participants (18–150 by default, set in the settings) is covered for both sexes without gaps;
• every range is marked as reviewed against the laboratory document.

The flag next to a value

What you see	What it means
L · 117–155 g/L	the value is below range
H · 117–155 g/L	the value is above range
range 117–155 g/L	the value is within range
range undetermined	the setup is incomplete: hover for a hint naming the reason

The flag is recomputed after every save of the value. Only those who see the value itself see the flag: the module reads data within the user’s permissions.

Permissions

• View laboratory ranges — see the catalogue, the checklist and the L/H flags in data entry;
• Maintain laboratory ranges — maintain laboratories, parameters and ranges, import a file.

Every module action is recorded in the audit trail.

What’s next

What are modulesEnablement, permissions, disabling.

Entering data in a formWhere values get their L/H flags.