Pragmatic trials run in ordinary clinics, where research is nobody's full-time job. The data system has to be minimal for sites, simple for participants and affordable across many sites. Capture is built for exactly that.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Meets eligibility (checklist complete)
Consent obtained
Participant email or mobile for questionnaires
What pragmatic trials need
Site burden
In a pragmatic trial, recruitment happens during normal clinical work. A clinician who has to spend fifteen minutes on a research form will stop enrolling, and the trial will end up with only the most research-enthusiastic sites, which undermines the point of a pragmatic design. The data system should ask sites for the minimum: eligibility confirmation, consent, a few baseline items and contact details for follow-up.
Outcomes then come from participants, by questionnaires sent to their phones, or from routine records where the protocol allows. Capture sends secure links by email or SMS that open in the phone browser with no app to install, with reminders and completion windows, so follow-up does not depend on the site.
Individually randomised pragmatic trials use randomisation at enrolment, often stratified by site. In Capture allocation happens automatically at enrolment with block size and stratification set once at setup. Cluster randomised designs allocate whole sites; record each site's allocation in the study documentation and carry it into the analysis dataset.
Now recruiting
Sleep and Recovery Study
A 12-week study of sleep quality after surgery. Takes 5 minutes a day on your phone.
Check if you can take partScan to join
Print it on posters and clinic flyers
Many sites
There is no per-site fee in Capture. Adding a site means inviting a coordinator and sharing a site-specific QR code or enrolment link. Each site sees only its own participants, and sponsor-side users see coded IDs.
Randomized
166 / 240
Open queries
24
Fields verified
84%
3 open queries · 92% SDV
7 open queries · 85% SDV
14 open queries · 61% SDV
0 open queries · 100% SDV
Site risk
Site 03 query backlog
Data lock
Site 04 ready to lock
Enrolment at the site, outcomes from the participant. Free sandbox.
PRECIS-2
| PRECIS-2 domain | More explanatory | More pragmatic |
|---|---|---|
| Eligibility | Narrow criteria, selected participants | Broad criteria, like usual care |
| Recruitment | Extra effort beyond usual practice | Through usual appointments |
| Setting | Specialist research centres | Ordinary clinics and practices |
| Organisation | Extra staff and resources | Existing staff and resources |
| Flexibility: delivery | Strict protocol for the intervention | Delivered as in usual care |
| Flexibility: adherence | Adherence monitored and enforced | No special measures |
| Follow-up | Frequent research visits | Minimal, often remote or from records |
| Primary outcome | Mechanistic or surrogate | Directly relevant to participants |
| Primary analysis | Per-protocol emphasis | Intention to treat with all data |
Each domain is scored separately; most trials sit somewhere between the two ends.
Cluster designs
Many pragmatic trials randomise practices, wards or hospitals rather than individuals, because the intervention is delivered at that level. Every participant record then needs the cluster identifier and the cluster's allocation, and the analysis must account for outcomes being more alike within a cluster than between clusters, measured by the intra-cluster correlation coefficient.
Cluster trials also carry a specific risk: if participants are identified and enrolled after the cluster knows its allocation, recruitment can differ between arms. Mitigations include identifying participants before allocation is revealed, using routine records to find eligible people, and monitoring recruitment by arm. Enrolment dates and site numbers in the study database make that monitoring straightforward. See sample size calculation for how clustering inflates the numbers needed.
Study build
Eligibility, consent, minimal baseline and contact details.
Scheduled questionnaires with reminders, no app.
Individual at enrolment, or cluster allocation documented.
Short training and an activation checklist per practice.
Approvals and identifiers in place if outcomes come from records.
Agreed with ethics, including any simplified or cluster consent models.
Testing an intervention under routine care conditions, with broad eligibility, usual settings and patient-relevant outcomes.
The minimum: eligibility, consent, a few baseline items and contact details. Outcomes should come from participants or routine records where possible.
No. Adding a site means inviting a coordinator and sharing an enrolment link.
Yes, through questionnaires in the phone browser with reminders.
Yes, in the free sandbox.
Keep exploring
Pragmatic clinical trial (glossary)
PRECIS-2 and design.
Multi-site clinical trial management
Many sites, one study.
EDC for RWE studies
Real-world evidence.
BYOD ePRO, no app
Outcomes from participants.
Rehabilitation research software
Often pragmatic.
Clinical trial software for European universities
Academic sponsors.
Minimal site burden, no per-site fees. Free sandbox.