TSH, free T4, free T3 and thyroid antibodies, each with a unit, a result and a reference range, plus the sampling details that make the numbers interpretable. Use it for thyroid disease trials or for thyroid safety monitoring in any study.
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Sample date and time
LBDTCTSH
TSHAbove reference range 0.4 to 4.0: auto-query raised
Free T4
FT4Free T3
FT3At a glance
In trials
In thyroid disease trials, such as Graves' disease, hypothyroidism or thyroid eye disease, thyroid function tests are efficacy or eligibility data: the protocol defines target ranges, and dose adjustments follow the results. In other trials they are safety labs, collected at baseline and at intervals to detect drug-induced thyroiditis, hypothyroidism or hyperthyroidism.
Either way, the result is only meaningful with its context. TSH varies through the day, free T4 in people taking levothyroxine depends on the time since the last dose, and assays differ between laboratories. Record the sampling time and, where relevant, the time of the last thyroid medication dose.
Thyroiditis is among the most common immune-related adverse events with checkpoint inhibitors, often with a brief hyperthyroid phase followed by hypothyroidism. Oncology protocols typically check TSH and free T4 at baseline and regularly during treatment. See EDC for oncology trials.
Haemoglobin HGB · g/dL
3 strataTemplate
| Field | Unit | Notes |
|---|---|---|
| Sample date and time | Date-time | For diurnal variation and dose timing |
| TSH | mIU/L | First-line test in most protocols |
| Free T4 | pmol/L or ng/dL | Record the unit reported |
| Free T3 | pmol/L or pg/mL | Where the protocol requires it |
| Anti-TPO antibodies | IU/mL | Autoimmune thyroid disease |
| TSH receptor antibodies | IU/L | Graves' disease and thyroid eye disease |
| Biotin use in last days | Yes / No | Assay interference check |
| Reference range low and high | Per analyte | From the performing lab |
Adapt analytes and units to your lab manual.
In Capture
Upload the lab manual and the AI drafts a lab table 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 an auto-query when a result falls outside the limits you set, and each repeating row keeps its own audit trail.
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.
Units and ranges
When sites use local laboratories, the same analyte arrives in different units with different reference ranges. Recording the result exactly as reported, with the unit and the lab's own range, keeps the source traceable; conversion to standard units and normalisation happen in analysis. A central lab removes most of this variability and is common where thyroid results drive efficacy endpoints.
For grading abnormal results as adverse events, oncology trials usually use CTCAE definitions, which refer to the lab's upper and lower limits of normal. That is another reason to store each result's range. See reference interval.
Before go-live
TSH, free T4, free T3 and antibodies as needed.
Unit field with every result.
Performing lab's range per result.
Time, last thyroid medication dose, biotin use.
Queries for values outside expected limits.
Baseline and interval monitoring per protocol.
TSH, free T4 and often free T3, with thyroid antibodies where needed, plus sample time, units and reference ranges.
Labs report free T4 and free T3 in different units, so the unit is needed to interpret and convert results.
Biotin supplements can interfere with some immunoassays and give misleading thyroid results.
Immune checkpoint inhibitors and some other cancer drugs can cause thyroiditis, hypothyroidism or hyperthyroidism.
Yes. AI drafts lab tables from a lab manual or file for your review. Nothing is saved without review.
Yes. Copy it into your study in the free sandbox.
Units, ranges and sampling details on one form. Free sandbox.