Endocrine endpoints are usually lab values: a hormone normalised, a level controlled, a growth rate improved. Getting them right depends on sampling times, assays and units. Capture structures the lab data, the schedule and the clinical context in one study.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Sample collection time
LBTIMFasting
LBFASTIGF-1
IGF1Within age- and sex-specific range
Growth hormone (nadir after OGTT)
GHNADIRWhat matters in endocrinology trials
Study design
A cortisol level means little without the time it was drawn, and a growth hormone value depends on whether it was a random sample or a nadir after an oral glucose tolerance test. Endocrine protocols therefore specify collection times, fasting, medication timing and test procedures precisely. The eCRF should capture those conditions next to the result, so deviations can be seen and handled.
Reference ranges matter just as much. IGF-1 normal ranges change markedly with age and differ by sex, so "normalisation" depends on the right range for each participant at each visit. Lab tables that hold ranges by sex and age, rather than a single range, keep the endpoint consistent.
Acromegaly, Cushing's disease, congenital adrenal hyperplasia and other rare conditions mean small trials, few sites per country and long recruitment. Randomised withdrawal designs and long extensions are common. See EDC for rare disease trials.
Haemoglobin HGB · g/dL
3 strataLaboratory data
AI drafts lab tables from a lab manual or file, with analytes as rows and unit, result and reference range columns, split by sex and age where the source has them. Nothing is saved without review. Range edit checks raise auto-queries at entry, and calculated fields such as BMI and age from date of birth are shown during entry.
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 |
Upload it to the free sandbox and review the lab table.
Endpoints
| Condition | Typical endpoint | Data to capture |
|---|---|---|
| Acromegaly | IGF-1 normalisation, GH control | IGF-1 with age- and sex-specific range, GH after OGTT, tumour imaging |
| Cushing's syndrome | Urinary free cortisol normalisation | Mean of repeated 24-hour UFC collections, completeness of collection |
| Hypothyroidism, Graves' disease | Thyroid hormone control, remission | TSH, free T4, free T3, antibodies |
| Hypoparathyroidism | Serum calcium in target, reduced supplements | Albumin-corrected calcium, supplement doses |
| Growth hormone deficiency | Annualised height velocity | Standardised height measurements, bone age |
| Osteoporosis | BMD change, new fractures | DXA results, fracture assessments |
Paediatric endocrinology
Height velocity is calculated from two height measurements months apart, so small measurement errors make a large difference. Protocols specify a wall-mounted stadiometer, the number of repeat measurements, the time of day and trained measurers. Record each measurement, not only the mean, so the calculation can be reviewed.
Children also grow out of age bands during a trial, which affects reference ranges and dosing. See EDC for pediatric trials for weight- and BSA-based dosing calculated at entry.
Study build
Time, fasting, medication timing and test procedure fields.
Age- and sex-specific where the analyte needs them.
Assays and units consistent across sites.
Each collection recorded, such as each 24-hour urine.
Repeat heights recorded individually.
Extension and bone or fracture assessments scheduled.
Yes, each as its own record with completeness details, so the mean is derived in analysis.
Yes. Results are recorded with the lab's units and reference ranges.
Many hormones vary through the day and with fasting, so the collection conditions are part of the result.
Yes. Lab tables can hold reference ranges split by sex and age where the source has them.
Yes. AI drafts lab tables from a lab manual or file for your review. Nothing is saved without review.
Record each standardised height measurement and date; height velocity is derived in analysis.
Yes. Small, multi-country studies with long extensions run in one study with site-level separation.
Yes, in the free sandbox with every feature.
Keep exploring
Lab tables, ranges and collection conditions. Free sandbox.