A screening trial tests a programme, not a drug: who was invited, who attended, what the screen found, who was recalled and what happened years later. Capture keeps each step as its own form with its own audit trail. Build free, no credit card.
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Randomised to invitation
Invited arm or usual care
Invitation sent, attendance recorded
Attended, declined, no response
Screen result entered
Negative, positive, technical recall
Recall and work-up
Further tests, diagnosis or discharge
Long-term outcome
Diagnosis, stage, death, year 5 and beyond
What a screening trial needs from its data collection
Why this is a different data problem
In a drug trial the unit of work is a visit. In a screening trial it is a pathway with branches. A person is randomised to be invited for a test (or to usual care), then may attend or not, then has a result that sends them one of several ways, and only a small fraction ever reach a diagnosis. The analysis question, often whether invitation reduces disease-specific mortality, depends on counting everyone in the invited group, including the many who never came. A data model that only stores completed visits loses exactly the information the primary analysis needs.
The practical design is one form per step. An invitation form records date, method and outcome (attended, declined, unreachable, ineligible after invitation). A screen form records the test, the reader or operator and the result category defined in the protocol. A recall form opens only when the result requires it, using skip logic, and a work-up form holds further tests and the final classification. In Capture, forms move from draft to approved and are locked for live use, and every field change keeps its own audit trail with the old value, new value and reason. Repeating rows suit multiple recalls or repeat screening rounds. For the design side of randomising groups of people rather than individuals, see EDC for cluster-randomised trials.
This page is about trials of screening programmes. If you need to screen individual volunteers for eligibility into an ordinary trial, that is a different job covered by patient eligibility screening software and the screening and enrolment log template.
Screening studies are prone to lead-time bias (earlier diagnosis looks like longer survival without changing the date of death) and length bias (slow-growing disease is over-represented among screen-detected cases). Randomised designs address them by comparing mortality across all randomised people rather than survival among those diagnosed. What the data capture must do is record dates precisely, record the mode of detection (screen-detected, interval, or detected outside the programme) and keep randomised arm and actual exposure separate, so contamination from screening done outside the trial can be recorded as well.
Invitation outcome
INVOUTDate of screen
SCRDTCResult category
SCRRESRecall date
RCLDTCOpens when result is positive or technical recall
2026-03-30Days from screen to recall
RCLDAYSCheck against protocol target
Where this fits
| Question | This page | Neighbouring page |
|---|---|---|
| Who is being screened? | A population invited by the programme, healthy at entry | Eligibility screening screens volunteers into a trial |
| What is randomised? | Often an invitation, a test or a schedule | Randomization in EDC for assigning arms |
| What is the unit of analysis? | Individuals or whole practices, towns or clinics | Cluster-randomised designs |
| How long does follow-up last? | Years, with outcomes after the screening rounds end | Pragmatic trial software for routine-care designs |
| What is the key safety data? | False positives, work-up burden, complications of recall tests | Adverse event reporting |
Create the invitation, screen, recall and outcome forms and enter a few dozen fake pathways. Free sandbox, no credit card.
Outcomes and consent
The main outcome of a large screening trial often comes from outside the study: a cancer registry, a death register or hospital records. Whether you can link to those sources, and under what legal basis, depends on the country and the ethics approval, and is a design decision for your team and your data protection officer. Capture does not claim any registry integration. Where outcome data arrive as files or reports, plan how a person on your team enters or loads them, and keep a form for outcome ascertainment with the source and date so every outcome can be traced. Exports are CSV or Excel with an automatic data dictionary, and CDISC SDTM datasets (SAS XPT with Define-XML) are available when a submission needs them.
Because the study stays open for years, think about who will still have access. Role-based access, PII segregation (staff who invite see names, researchers work from coded IDs) and the field-level audit trail matter more over a long period than any single feature. Data is hosted in the EU (Frankfurt) or the USA (N. Virginia), which you choose with your data protection requirements in mind.
Consent in a screening trial has its own challenge: the participants are mostly well and the information has to explain benefits and harms of screening, including false reassurance and false alarms, in a way a non-specialist can follow. Capture eConsent provides on-screen signature with email OTP confirmation, investigator countersignature and exportable signed PDFs; where invitation is by post and the participant decides at home, the secure-link flow suits that. Whether consent is required before invitation, or whether a trial can use a waiver or an opt-out route, is an ethics committee question; do not assume it. See what eConsent is.
Build sequence
Draw invitation, attendance, result, recall, work-up and outcome on one page, with the allowed result categories at each step.
Upload the protocol (PDF, DOCX or DOC) and let the AI study builder propose visits and forms. Nothing is saved until a person reviews it.
Open the recall form only when the result requires it, and add date-order rules so recall cannot precede the screen.
Each screening centre or practice becomes a site with its own numbering; decide who sees names and who sees only coded IDs.
Enter completers, non-attenders, false positives and a participant who leaves the programme, then export and check the counts.
Approved forms lock for live use. Real participants start the paid live phase.
Before first invitation
Every screen result maps to exactly one category in the protocol, with a rule for technical failures.
An invitation outcome form exists for every randomised person, not only attenders.
Registry or record linkage, legal basis and who loads the data are written down.
A field for screening done outside the trial, so it can be analysed.
False positives, work-up procedures and complications are listed as data to collect.
CSV or Excel with the data dictionary opened in the statistics package.
No. Eligibility screening decides whether a volunteer can join a trial. A screening trial tests whether a screening programme itself changes outcomes. The forms, the denominator and the follow-up are different.
Yes. Record an invitation outcome for every randomised person, with a category such as attended, declined or no response, so they remain in the dataset for an intention-to-screen analysis.
No registry integration is claimed. Your team decides how outcome data are obtained and then enters or loads them, with the source and date recorded on an outcome form.
Yes. Capture supports multiple sites with site-level participant numbering, a site coordinator portal and by-site filtering and exports. See multi-site clinical trial management.
The field-level audit trail, role-based access and exports are built for long studies, but you should plan data retention and archiving with your sponsor and ethics committee.
No. The result category is entered by the person reading the test, following the protocol. Edit checks can enforce valid dates and combinations but are not clinical alerts.
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Keep exploring
EDC for cluster-randomised trials
When practices or towns are randomised.
Patient eligibility screening
Screening volunteers into a trial.
Screening and enrolment log template
Track who was screened and why.
Pragmatic trial software
Routine-care designs.
Multi-site trial management
Several screening centres, one view.
eConsent
Consent on the participant's phone.
Pricing
Free sandbox, pay at go-live.
Free sandbox with every feature. No credit card, and you pay only when you go live.