Normal or abnormal for each body system, a description only when something is abnormal, and a clinical significance decision that links to the AE log when it matters.
Free sandbox · No credit card · 21 CFR Part 11 aligned
General appearance
PETESTSkin
Skin: describe finding
Clinically significant?
Recorded in medical history at baseline
Cardiovascular
What this template gives you
Design
Physical exam CRFs often become long pages of free-text boxes, one per body system, filled with "NAD", "normal", "WNL" or nothing at all. None of that is analysable, and blank boxes generate queries asking whether the system was examined. A structured design fixes both problems: a coded result for every system and text only where it is needed.
In Capture the template uses a table section, with body systems as rows and the result, description and clinical significance as columns. Skip logic shows the description and significance only when the result is abnormal, so a normal exam takes seconds and an abnormal one has everything a medical monitor needs.
Not every abnormal finding matters clinically: a healed scar is abnormal but insignificant. The investigator's clinical significance judgement drives what happens next. At baseline, clinically significant findings go into medical history. After consent, a new or worsened clinically significant finding is assessed as a possible adverse event.
Many protocols require a full exam at screening and end of study, and a targeted exam driven by symptoms at other visits. Build them as two forms placed at the right visits, rather than one form with a "full or targeted" switch that makes the structure ambiguous.
| Analyte | Result | Unit | Ref. range |
|---|---|---|---|
| Haemoglobin | 13.8 | g/dL | 13.0 to 17.0 |
| White blood cells | 6.2 | 10^9/L | 4.0 to 10.0 |
| Platelets | 412 | 10^9/L | 150 to 400 |
Structure
| Row | Result | Shown when abnormal |
|---|---|---|
| General appearance | Normal / abnormal / not done | Description, clinical significance |
| Head, eyes, ears, nose and throat | Normal / abnormal / not done | Description, clinical significance |
| Skin | Normal / abnormal / not done | Description, clinical significance |
| Lymph nodes | Normal / abnormal / not done | Description, clinical significance |
| Cardiovascular | Normal / abnormal / not done | Description, clinical significance |
| Respiratory | Normal / abnormal / not done | Description, clinical significance |
| Abdomen | Normal / abnormal / not done | Description, clinical significance |
| Musculoskeletal | Normal / abnormal / not done | Description, clinical significance |
| Neurological | Normal / abnormal / not done | Description, clinical significance |
| Other (specify) | Normal / abnormal / not done | System name, description, clinical significance |
Add or remove systems to match the protocol. Each table row carries its own audit trail.
Monitoring
With risk-based monitoring, SDV can focus on abnormal, clinically significant findings rather than every normal result. SDV is set per field in Capture, and can change after approval without a new form version.
Changed by Data manager · reason: critical safety value added
Enter an abnormal finding and watch the follow-up fields appear.
Consistency
Physical examination findings depend on who examines. A skin finding one investigator calls clinically significant another may not. Protocols reduce that variability by naming who may perform examinations (usually medically qualified staff on the delegation log), defining which systems are examined at which visits, and asking for the same examiner where possible for endpoints that depend on examination.
The clinic notes are normally the source document for the exam; the eCRF records the structured result. Monitors verify abnormal, clinically significant findings against the notes, and the audit trail shows who entered each result. If an exam was not done at a visit where it was scheduled, record it as not done rather than leaving it blank, so the gap is explained.
Before you approve
Add or remove rows before approval.
Placed at the right visits.
Delegation log shows qualified staff.
Baseline findings to medical history; new findings assessed as AEs.
Explicit, with a reason where the protocol requires.
Abnormal, clinically significant findings.
Each body system with a normal, abnormal or not done result, and a description and clinical significance decision for abnormal findings.
No. A coded normal result is enough; text only adds noise. Show a description field only for abnormal findings.
When it is new or worse than baseline after the AE reporting period begins and the investigator judges it clinically significant, per your protocol.
Usually two forms, placed at the visits where each is required.
Yes, in the Capture template library in the free sandbox.
Keep exploring
Medical history eCRF template
Where baseline findings go.
Vital signs eCRF template
Measured at the same visit.
Adverse event eCRF template
New or worsened findings.
Lab results eCRF template
Clinical significance for labs.
How to design an eCRF
Table sections and skip logic.
Source data verification
Verifying exam data.
Copy the physical exam template into your study. Free sandbox.