Blood pressure, pulse, respiratory rate, temperature, weight and height, with BMI, mean arterial pressure and pulse pressure calculated as sites type. Range checks raise a query the moment a value looks wrong.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Systolic blood pressure
SYSBPAuto-query: above 250 mmHg, please confirm
Diastolic blood pressure
DIABPPulse rate
PULSEWeight
WEIGHTBMI
BMIMean arterial pressure
MAP9
measurements in the template
3
values calculated automatically: BMI, MAP, pulse pressure
0
hand calculations for sites
1
form used at every visit on the schedule
What this template gives you
Design basics
Vital signs are collected at almost every visit of almost every study, so small design choices multiply. A form that lets sites type weight in pounds at one visit and kilograms at the next, or leaves blood pressure position blank, creates hundreds of queries over the life of a study. A form that fixes units, asks for position and time, and calculates BMI itself removes most of them before they exist.
The template records each measurement as a number with a fixed unit and a sensible decimal precision, then adds the context that makes it interpretable: body position, which arm, and the time of measurement relative to dosing where that matters.
Capture has built-in clinical calculators that run during entry: BMI, body surface area (Mosteller and Du Bois), waist-hip ratio, mean arterial pressure and pulse pressure among them. On the vital signs form BMI, MAP and pulse pressure are shown read-only as soon as their inputs are entered. Because they are derived rather than typed, they cannot disagree with the measurements they come from.
Each measurement has a high and low range edit check. A systolic pressure of 262 is not refused (it may be real), but it raises an auto-query in the site action list asking the coordinator to confirm. Sites fix typos in seconds while the participant is still there, instead of weeks later from a monitoring report. Edit checks carry a priority, so a physiologically impossible value can be flagged more urgently than a merely unusual one.
Many cardiovascular and early-phase protocols ask for blood pressure in duplicate or triplicate, a few minutes apart, and analyse the mean. The template includes a table section for repeat readings: each row is one reading with its own time and its own audit trail. The mean is computed in analysis from the exported rows.
BMI (Body Mass Index)
Auto-derivedHeight (cm)
172
Weight (kg)
68.5
Result
23.2 kg/m²
Reference: WHO · shown read-only during data entry
Field specification
Default ranges are deliberately wide: they catch typing and unit errors, not clinical abnormality. Tighten them to your population, and use protocol-specific alert limits for safety.
| Measurement | Variable | Unit | Default check range | Notes |
|---|---|---|---|---|
| Systolic blood pressure | SYSBP | mmHg | 60 to 250 | Record position and arm. |
| Diastolic blood pressure | DIABP | mmHg | 30 to 150 | Recorded with the same position and arm as systolic. |
| Pulse rate | PULSE | beats/min | 30 to 200 | Note if measured by device or manually. |
| Respiratory rate | RESP | breaths/min | 6 to 40 | |
| Temperature | TEMP | °C | 34.0 to 42.0 | Add route (oral, tympanic, axillary) if needed. |
| Weight | WEIGHT | kg | 20 to 300 | One decimal place. |
| Height | HEIGHT | cm | 100 to 230 | Often screening only. |
| BMI | BMI | kg/m² | Calculated | From weight and height on the form; keep height on visits where BMI is needed. |
| Mean arterial pressure and pulse pressure | MAP, sponsor-defined | mmHg | Calculated | Shown read-only during entry. |
Variable names follow CDASH-style VS test codes and the form carries the SDTM VS domain label.
On the schedule
Vital signs are usually collected at screening, baseline, every dosing visit and follow-up. In Capture the form is built once and placed on the schedule at each visit, with visit windows so late visits are flagged. The status overview then shows which subjects are missing vital signs at which visit.
| Assessment | Scr | D1 | W2 | W4 | W8 | W12 | FU |
|---|---|---|---|---|---|---|---|
| Vital signs | |||||||
| Height | |||||||
| Weight | |||||||
| ECG | |||||||
| Labs |
The vital signs template and its edit checks are ready in the free sandbox.
Before you approve the form
One unit per measurement across all sites. Convert pounds and Fahrenheit at source, not in the database.
State in help text, for example seated after five minutes of rest.
Wide defaults catch typos. Add tighter alert limits only where the protocol defines them.
Keep or remove the repeat-readings table section to match the protocol.
Add pre-dose and post-dose time points for pharmacology studies.
Blood pressure and weight are commonly verified; derived values are excluded from SDV automatically.
Usually systolic and diastolic blood pressure, pulse rate, respiratory rate, temperature, weight and height, with the position and time of measurement.
Yes. BMI is a built-in calculated field, shown read-only as soon as weight and height are entered. MAP and pulse pressure work the same way.
An edit check raises an auto-query in the site action list asking the coordinator to confirm or correct the value. Entry is not blocked, because unusual values can be real.
Yes. The template includes a table section for repeat readings, each row with its own time and audit trail.
mmHg, beats per minute, breaths per minute, degrees Celsius, kilograms and centimetres. Change them in the draft form if your protocol differs.
Field names follow CDASH-style VS test codes and the form carries the SDTM VS domain label. It is not a validated SDTM transformation.
Yes, in the free sandbox. You pay only when a study goes live with real participants.
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Copy the vital signs template and let the form do the maths. Free sandbox, no credit card.