Haematology, chemistry and urinalysis as tables of analytes with result, unit and the local reference range for the participant's sex and age. Out-of-range values turn red and ask for a clinical significance decision.
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Haemoglobin HGB · g/dL
3 strataWhat this template gives you
Why it matters
Safety laboratory tests (liver enzymes, kidney function, blood counts) are among the most important safety data in any interventional study, and among the most error-prone. Values arrive in different units from different laboratories, reference ranges differ by lab, sex and age, and the key question for each out-of-range value, whether it is clinically significant, needs the investigator's judgement.
The lab template handles each of those problems at entry. Units are fixed per analyte, the correct range for the participant is applied automatically, and the clinical significance question appears only for out-of-range values. The result is lab data that supports shift tables and safety review without months of reconciliation. See reference intervals for how ranges are set.
With a central laboratory, results arrive electronically with one set of ranges. With local laboratories, each site's lab has its own ranges, and the eCRF needs to know which lab produced each result. Capture stores ranges per laboratory and compares them across labs in one matrix, so multi-site studies using local labs stay consistent.
A haemolysed sample or a test not performed should be recorded as not available, per analyte, rather than left blank. Exports distinguish these markers from genuinely missing data.
| Analyte | Result | Range | Significant? |
|---|---|---|---|
| ALT | 212 U/L | 7-56 | Yes |
| Creatinine | 0.9 mg/dL | 0.6-1.2 | - |
Alert value
Routed to the medical monitor and PI
One step
Raise adverse event from this result
Panels
| Panel | Example analytes | Notes |
|---|---|---|
| Haematology | Haemoglobin, haematocrit, red and white cell counts, differential, platelets | Ranges often differ by sex. |
| Clinical chemistry | ALT, AST, ALP, bilirubin, creatinine, urea, electrolytes, glucose, albumin | eGFR calculated from creatinine, age and sex. |
| Urinalysis | pH, specific gravity, protein, glucose, blood, ketones | Dipstick results as coded choices. |
| Coagulation (optional) | PT, INR, aPTT | Add where the protocol requires. |
| Protocol-specific | HbA1c, lipids, thyroid function, pregnancy test | Separate tables per panel. |
Every lab form carries the SDTM LB domain label. Adjust analytes to your protocol and lab manual.
Build faster
Upload the lab manual or range sheet (CSV, XLSX, PDF or DOCX) and the AI form builder drafts the analyte tables, units and default ranges, split by sex and age where the source has them. Unrecognised analytes are flagged, never guessed, and nothing is saved until you review it.
Haematology
| Row | Code | Unit | Range | Stratum |
|---|---|---|---|---|
| Haemoglobin | HGB | g/dL | 13.0-17.0 | Male 18-65 y |
| Haemoglobin | HGB | g/dL | 12.0-15.5 | Female 18-65 y |
| Platelets | PLAT | 10^9/L | 150-400 | All |
| ALT | ALT | U/L | 7-56 | All |
| Site QC flag | SITEQC | - | - | All |
Build lab panels in minutes in the free sandbox.
Safety analysis
Lab safety analysis usually includes shift tables (how many participants moved from normal to high or low between baseline and later visits), listings of values beyond alert limits, and specific checks such as potential drug-induced liver injury. The widely used Hy's law screen looks for an aminotransferase above three times the upper limit of normal together with total bilirubin above twice the upper limit of normal. All of these depend on the reference range stored with each result, which is why ranges must be per laboratory and per participant stratum.
Designing the lab form with those analyses in mind means recording the collection date and time, the laboratory, the unit and the range with every value, and the investigator's clinical significance judgement for out-of-range results. That is exactly what the template does.
When local labs report in different units, the safest approach is to record the value in the unit the lab reported, with the unit as its own field, and convert centrally in analysis using documented factors. Converting by hand at the site is a common source of errors.
Before you approve
Match the lab manual; convert at source if labs differ.
By sex and age, with no overlaps or gaps.
Which values trigger a routed safety alert, and to whom.
Who assesses, and when it becomes an AE.
Per analyte, instead of blanks.
Date and time of collection, fasting status if relevant.
For each analyte: the result, unit and reference range, plus clinical significance for out-of-range values and the sample collection date and time.
Each laboratory has its own ranges by sex and age, and Capture applies the most specific range for each participant.
No. They are flagged in red and trigger a clinical significance question. Entry is never refused.
Yes. A clinically significant result can raise an AE without losing the lab entry.
Yes, in the Capture template library in the free sandbox.
Ranges applied automatically, alerts routed. Free sandbox.