Age, sex, race and ethnicity feed every baseline table and every subgroup analysis. This template collects them in the format analysts expect, with only as much identifying detail as your protocol needs.
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Date of birth
BRTHDATYear only in EU studies by default
1971Age at informed consent
AGESex
SEXEthnicity
ETHNICRace (select all that apply)
RACEKey points
Why it matters
A demographics form looks trivial: five or six questions that take a coordinator under a minute. But it drives the first table of every clinical study report, the eligibility check on age, stratification factors for randomisation, and every subgroup analysis by sex, age band or race. Errors here propagate everywhere, which is why it pays to design the form carefully rather than typing questions from memory.
The template keeps the form short and structured. Every answer is a controlled choice or a date, so exports tabulate without recoding, and each field carries a CDASH-style variable name with the SDTM DM domain label on the form.
Exact date of birth is identifying data. Paediatric studies, where age in months matters, usually need it. Adult studies rarely do: year of birth, or age at consent, is enough for eligibility and analysis. Under GDPR the data minimisation principle means you should collect the least identifying option that answers the scientific question, and ethics committees increasingly ask why a full date was needed.
Whichever you choose, let the system do the arithmetic. With a date of birth, Capture calculates age automatically as a read-only field, which removes a whole class of transcription queries.
Most protocols need biological sex for safety and pharmacokinetic reasons, and reference ranges for many lab analytes are split by sex. Some studies also collect gender identity as a separate optional question. Keep the two distinct, and state in the help text which one the field records.
For US submissions, FDA guidance on collecting race and ethnicity data has long used a two-question format with the US government (OMB) minimum categories, and self-report by the participant. OMB revised those standards in 2024, introducing a combined question and a Middle Eastern or North African category, with a transition period for federal agencies. Check which format your regulator and sponsor currently expect before you approve the form.
In Europe, racial or ethnic origin is special category data under GDPR Article 9. Collect it only where it is scientifically justified, say why in the protocol and consent form, and always offer "prefer not to say". Studies that need a diversity action plan will lean on this form to report enrolment against targets.
Enrolled
64 / 80
Female
52%
Age 65+
18%
Target 40
Target 20
Target 12
Field specification
| Field | Variable | Question type | Default | Notes |
|---|---|---|---|---|
| Date of birth or year of birth | BRTHDAT | Date | Year only | Switch to full date for paediatric studies. |
| Age at informed consent | AGE | Calculated | Derived | Age from date of birth, read-only during entry. |
| Age unit | AGEU | Fixed | Years | Months or weeks for neonatal and infant studies. |
| Sex | SEX | Single choice | Required | Biological sex; used for sex-specific lab ranges. |
| Gender identity | Sponsor-defined | Single choice | Off | Optional, separate from sex. |
| Ethnicity | ETHNIC | Dropdown | US studies | Includes "not reported" and "unknown". |
| Race | RACE | Multiple choice | US studies | Self-reported; allow more than one answer. |
| Country of residence | COUNTRY | Dropdown | Multi-country studies | Often derived from site instead. |
| Childbearing potential | Sponsor-defined | Single choice | If protocol requires | Drives contraception and pregnancy test forms. |
The form carries the SDTM DM domain label. Capture templates are CDASH-style, not a validated SDTM transformation.
Privacy by design
Personal identifiers never belong on the eCRF. Capture keeps them apart: site coordinators see participant names so they can run visits, while researchers and monitors see coded IDs such as 001-0042. The separation is enforced with row-level security at the database layer, not just hidden in the interface.
Site coordinator
Jane Peterson
DOB: 04-Mar-1978
Subject 01-004
Sees direct identifiersResearcher
Subject 01-004
DOB: withheld
Coded ID only
Sees coded ID onlySame record, two roles. Row-level security enforces the split.
Where it sits
The screening wizard records consent date, year of birth and sex as it issues the screening number, and the demographics form completes the picture at the same visit. The rest of the screening visit (eligibility, medical history, vitals) follows on the schedule.
Start screening
Screen new subject
Not screened before
Rescreen subject
Needs a new screening number
ICF date
14-Sep-2026
Year of birth
1971
Sex
Female
Copy it from the template library, choose year or full date of birth, and watch age calculate itself.
Before you approve the form
Year only unless the protocol needs exact age. Note the reason in your data management plan.
Match the format your regulator expects, or remove the questions for studies where they are not justified.
Self-reported characteristics need a way to decline.
Make sure the eligibility form uses the calculated age, not a separately typed one.
Anything collected here should be described in the participant information and consent form.
Include the blank eCRF PDF in the ethics or IRB package.
Typically date or year of birth, age, sex, and where justified race and ethnicity. Some studies add childbearing potential, gender identity or country of residence.
Only if the analysis needs exact age, for example in paediatric studies. Year of birth or age at consent is less identifying and is usually enough for adult studies.
Yes. Age from date of birth is one of the built-in calculated fields and is shown read-only during data entry.
For studies supporting US FDA submissions it is generally expected. In the EU it is special category data under GDPR and needs a scientific justification. Always allow participants to decline.
Field names follow CDASH-style conventions (BRTHDAT, AGE, SEX, RACE, ETHNIC) and the form carries the SDTM DM domain label. SDTM datasets are still produced by your programmers.
Not on the eCRF. Coordinators see names in the site view; researchers see coded IDs. The separation is enforced by row-level security.
Yes, in the free sandbox with the rest of the library. You pay only when a study goes live.
Keep exploring
Eligibility screening eCRF template
Inclusion and exclusion criteria at screening.
Vital signs eCRF template
The next form on most screening visits.
Diversity action plan guide
Why structured demographics matter for FDA.
GDPR compliant trial software
Data minimisation and EU hosting.
What is a CRF?
Case report forms explained.
eCRF software
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