One question per inclusion and exclusion criterion, an investigator confirmation, and edit checks that flag an ineligible answer before the participant is enrolled or randomised.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Inclusion criteria
I1. Aged 18 to 75 at consent
INCL01I2. BMI 27 to 40 kg/m²
INCL02Exclusion criteria
E3. eGFR below 45 mL/min/1.73m²
EXCL03Exclusion present: subject is not eligible
Key points
Why it matters
Enrolling a participant who does not meet the criteria is one of the most frequently reported protocol deviations, and one of the costliest. The participant may have to be withdrawn, their data may be excluded from the per-protocol analysis, and an inspector will ask how the site confirmed eligibility. A paper checklist signed in a hurry at the end of a long screening visit rarely holds up.
An eligibility eCRF turns the protocol criteria into a structured record. Every criterion has an answer, every answer has an audit trail entry, and the investigator confirms the whole set with an electronic signature. If something is wrong, an edit check says so while there is still time to stop.
Protocol criteria are often compound ("adults aged 18 to 75 with type 2 diabetes for at least six months on a stable dose of metformin"). On the form, split compound criteria so that each question has one clear met or not-met answer, and number them exactly as the protocol does (I1, I2, E1, E2) so monitors can trace every answer back.
Where a criterion depends on a measured value such as age, BMI or eGFR, record the value itself rather than only a tick, so the investigator confirms against data rather than memory. Capture calculates BMI, age from date of birth and eGFR (CKD-EPI 2021) as built-in derived fields, shown read-only during entry.
In SDTM, the IE domain records only the criteria that were not met. On the eCRF you still ask every criterion, because the positive record is what proves eligibility was assessed. The template carries the IE domain label, and your programmers derive the IE dataset from the exported answers.
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
Investigator confirmation
The final question on the form is the investigator confirmation that the participant meets all criteria. Signing asks for the password again, verified on the server, and stores the signer, the time and the meaning of the signature. Signing under delegation is recorded as such.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Template structure
| Section | Question type | Edit check | Why |
|---|---|---|---|
| Protocol version | Dropdown | Required | Criteria change between amendments. |
| Inclusion criteria (one per row) | Single choice: met / not met | Query if any answer is not met | Every criterion assessed and auditable. |
| Exclusion criteria (one per row) | Single choice: not present / present | Query if any answer is present | Same, for exclusions. |
| Supporting values | Number or calculated field | Range check on the value | Age, BMI or eGFR recorded, not just ticked. |
| Eligible? | Single choice | Query if answered Not eligible | A single field for the enrolment decision. |
| Screen-failure reason | Dropdown plus text | Required when not eligible | Structured reasons feed screening reports. |
| Investigator confirmation | Electronic signature | Required before enrolment | Accountability for the eligibility decision. |
Screen failures and rescreening
A participant who fails screening keeps their screening number and a structured reason. If the protocol allows rescreening, the screening wizard issues a new screening number, so the first attempt and the rescreen remain two traceable records instead of one overwritten one.
Site risk
Site 03 needs attention
Action items
2 overdue
Use the AI form builder to turn protocol criteria into questions, then review every one before approving.
Protocol amendments
Eligibility criteria are among the most frequently amended parts of a protocol, usually to widen enrolment. When that happens the form has to change without confusing which participants were screened under which version. In Capture, the amended form goes back through draft and approval; approved forms are locked for live use and shared identically across every site, so there is no period where one site screens against old criteria and another against new ones.
Record the protocol version on the form (the template has a field for it) so every eligibility decision can be tied to the criteria that applied at the time. For the wider picture see protocol amendments without change orders.
The electronic case report form where sites record whether a participant meets each inclusion criterion and none of the exclusion criteria, and where the investigator confirms eligibility.
Yes. One criterion per question, numbered as in the protocol, makes eligibility auditable and lets edit checks flag the exact criterion that failed.
Edit checks raise a query as soon as an inclusion is not met or an exclusion is present, and the investigator confirmation is required before enrolment. Your procedures define who resolves the query.
With a structured screen-failure reason on the form. The participant keeps their screening number, and rescreening issues a new one.
Yes. The AI form builder can draft questions from a description or an uploaded file. Nothing is saved until a person reviews and applies it, and it only works on draft forms.
The updated form goes through draft and approval again. Approved forms are locked and identical at every site, and the protocol version field ties each answer to the criteria in force.
Yes, in the free sandbox with the rest of the template library.
Keep exploring
Patient eligibility screening software
Screening workflows beyond the form.
Clinical trial pre-screening tools
Online pre-screening before the site visit.
Demographics eCRF template
Age and sex used by the criteria.
Protocol deviation tracking
When an ineligible participant slips through.
Pre-screening consent template
Consent for pre-screening activities.
Randomization software
What happens after eligibility is confirmed.
Copy the eligibility template, add your criteria and test it free. No credit card.