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DM workspace

Lab normal ranges

Load ranges per site, keep versions, check a lab export against them.

Each site’s lab has its own normal ranges and units, and they change during the study. Here ranges are kept in the DM project in versions (menu “Lab normal ranges” of the project), and a lab export is checked against them in a minute. The whole project team sees the ranges; the project manager and data managers load them and run the check.

Ranges

  • One row: site, lab, test code and name, unit, sex, age from and to, low and high limit, valid from and to. Download the template on the page.
  • A row without a site applies to every site (central lab). When a site has its own range, that one is used.
  • Versions. Every upload is a new version; older ones stay active. Samples taken before a change keep their old range, and when two rows fit one sample the newer version wins. A wrong version can be retired with a reason: it stays in the history, its file can be downloaded, and the audit trail shows who loaded and retired it.
  • A file with errors is not saved: the portal lists rows where a limit is not a number, low is above high, the unit is missing, sex is not M or F, dates are reversed or two rows would apply to the same sample.

Checking an export

Upload lab data from the EDC or the lab, one row per result. SDTM columns (SITEID, SUBJID, LBDTC, LBTESTCD, LBORRES, LBORRESU, SEX, AGE, LBNRIND, LBCLSIG), Rave, REDCap and Russian names are recognised.

  • Below and above range using the site’s range on the sample date, by sex and age. The report shows which ranges version was applied.
  • Unit conversion: g/dL and g/L, mg/dL and mmol/L for glucose, creatinine, cholesterol, bilirubin and others, 10^9/L and 10^3/µL, µkat/L and U/L. When a conversion is not possible the result is marked “units cannot be compared”.
  • Clinical significance not assessed: out of range with an empty CS/NCS column.
  • The lab’s flag disagrees with the range on file, and the lab printed other limits: this catches a lab still working with old ranges.
  • Results like “<5” and “>200” are compared where the answer is certain. Text results are not compared.
  • “No range on file”: which tests and sites to add to the next version.

Example

“Open the example project” creates your DM project DEMO-LAB with ranges of two sites and a central lab: haemoglobin by sex, creatinine in µmol/L and mg/dL, glucose in mmol/L and mg/dL, and site 02’s ALT range that changed on 1 July. Then “Check the example lab export”: ALT 50 U/L for 02-001 is normal in May and above range in August, although the lab flagged it as normal.

Sources

What is stored. Ranges are stored: they are reference data of the study, not personal data. The lab export is read in memory and not stored; the audit trail keeps only the counts.