When a nurse visits the participant instead of the participant visiting the clinic, the data still has to land on the same forms, with the same checks, under the same audit trail. Capture lets a visiting nurse enter the visit in a browser, as a named site user, against the visit the protocol defines.
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Home visit · vitals and samples
Subject 002-0017 · Visit 3 (Week 6, home) · Demo study
Visit details
Visit location
Visit date
Performed by
Vital signs
Systolic BP
Auto-query: value above the range set for this field
Diastolic BP
Blood sample collected
At a glance
1
visit definition shared by clinic and home visits
Field-level
audit trail with user, time, old and new value, reason
Free
sandbox with every feature, no time limit
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hosting in Frankfurt or N. Virginia
Why home visits
Home nursing visits are used where travel is the main reason people drop out: participants with limited mobility, families with young children, people living far from a site, or studies with frequent short visits such as weekly blood pressure or injection checks. The nurse takes the measurements, collects samples, checks the study drug and records adverse events, then the sample or the data goes back to the site team.
From a data standpoint nothing about the protocol relaxes. Eligibility, vital signs, concomitant medications and adverse events are still collected in the same definitions, and the visit still has to fall inside its window. What changes is the working environment: a kitchen table instead of an examination room, one nurse instead of a site team, and a longer gap between the visit and anyone else seeing the data. Software has to shorten that gap, which is why entry-time checks matter more here than in a clinic.
It also changes who is responsible. In a hybrid design the investigator remains accountable for the participant, so the nurse's entries need to be attributable to a named person and reviewable by the site. Our decentralized trial EDC page covers the wider model; this page is about the visit itself.
Mixing clinic and home
A typical hybrid schedule keeps the assessments that need equipment at the site and moves simple, repeatable ones to the home. This is an example, not a rule.
| Visit | Where | Data the nurse or site records | Typical checks |
|---|---|---|---|
| Screening and baseline | Clinic | Eligibility, history, full exam, baseline labs | Required fields, eligibility logic |
| Week 2 safety check | Home | Vital signs, concomitant medications, adverse events | BP and pulse ranges, AE onset after consent |
| Week 6 sample visit | Home | Blood draw time, tube count, study drug check | Sample time against visit window |
| Week 12 assessments | Clinic | ECG, performance test, imaging if in protocol | Calculated fields such as QTc |
| Month 6 follow-up | Home | Vitals, questionnaires on the participant's phone | Completion window, reminders |
Whether an assessment can be done safely and reliably at home is a protocol and ethics decision, not a software one.
In Capture
Define the visit in the schedule with its anchor and window, attach the forms, and add a short visit details form (or fields on the first form) that records the location, the date, and who carried it out. Because the same vital-signs template serves both settings, the data lands in one column per variable, not in two files that someone has to merge. Start from the vital signs eCRF and the adverse event eCRF and add the location field.
Each visit is anchored to screening, an earlier visit, a milestone, a fixed study day or a date recorded on a form, with a window and an enforcement mode. That matters for home visits because they are booked by phone and drift. A nurse who books the week 6 visit for day 52 should see that the window closes at day 49 before the participant is in the house, not at database cleaning. The schedule of assessments builder is the quickest way to lay the grid out.
For the nurse's login, use the site coordinator role at the relevant site. Site coordinators see participant names at their own site, researchers and sponsor-side users work with coded IDs, and sites see only their own participants, so a home visit nurse employed by a vendor or a partner clinic does not see other sites. Sites are enrolled with site-level participant numbers such as 002-0017, so a participant seen at home and at the clinic keeps one record. The delegation log template is where the investigator documents who may do what.
| Assessment | Screen | Wk 2 | Wk 6 | Wk 12 | Mo 6 |
|---|---|---|---|---|---|
| Location | Clinic | Home | Home | Clinic | Home |
| Vital signs | |||||
| Blood sample | |||||
| AE and con meds | |||||
| Diary / questionnaire | D | D | Q |
x = done at visit · D = daily diary on phone · Q = questionnaire on phone
Create a visit with a window, enter a vital sign outside its range as a site user, and watch the auto-query appear. Free sandbox, no credit card.
The workflow
The participant consents, remotely or at the first clinic visit. Remote signing uses an email one-time code and an acknowledgement of the legal-binding statement, and the investigator countersigns. See remote consent for clinical trials.
The coordinator checks the participant's status overview for the next due visit and window, and books the nurse inside it.
The nurse signs in, opens the participant and visit, and enters vitals, samples and study drug checks. Edit checks raise auto-queries on values that break a rule.
Sample collection time and tube counts go on the visit form. Where the study uses kits, dispensing is linked to the visit and committed under e-signature.
The site team sees the new entries, answers queries and, where source data verification is set per field, checks them against the nurse's source notes.
Participants complete diaries on their own phones with reminders by email or SMS; compliance is visible by site.
Data quality
The failure modes at home are different from the clinic. Vitals are taken with portable equipment, so device identifiers belong on the form. Samples travel, so time of collection and time of dispatch both matter, and a tube count helps the lab reconcile later. Concomitant medications are easier to see on a kitchen counter than in a clinic and are worth a prompt on every home form. A single dropdown for visit location lets you compare data quality between settings during analysis, which is often the first question a reviewer asks of a hybrid design.
Because Capture records every change with user, time, old value, new value and reason, a correction made the next day by the nurse after a query is visible and explained, not silently overwritten. If the nurse writes down values on a paper worksheet at the bedside because there is no signal, the worksheet is the source, and the entry date on the eCRF should be the date the nurse entered it, which the audit trail records. State this fallback in the monitoring plan before the first home visit, since offline entry is not available today.
Pair the visit data with participant-reported data. A patient diary between visits explains outliers at the next one, and remote patient monitoring covers the wider pattern of measurements taken outside the clinic.
Before the first home visit
A coded field on every visit form: clinic, home or other.
Anchor and window per visit, with the enforcement mode you want.
Site coordinator role at the correct site, listed on the delegation log.
Ranges on vitals and a required sample time.
Paper worksheet as source, entered later; stated in the monitoring plan.
Which fields are checked against the nurse's notes.
Protocol, consent and participant materials describe the setting.
Fit and limits
Capture is the data system for the visit, not a nurse-logistics platform. It does not dispatch nurses, route their travel or manage their shifts, and it is not a telehealth tool. Many sponsors use a nursing vendor for that and ask the vendor's nurses to enter data in the study as site users; others use the site's own staff. Either way the data capture, queries and audit trail sit in one place. For studies where participants also send data from wearables, see EDC for wearable device studies.
A data capture system that handles the same visit definitions, eCRFs and edit checks for home and clinic visits, attributes each entry to a named user and keeps a field-level audit trail. Nurse scheduling and travel are usually handled by the nursing vendor.
Yes. A nurse can be set up as a site user with a named login and enters the visit in a browser against the participant and visit. Every change is recorded with user, time, old value, new value and reason.
Offline entry is not available today. Plan home visits around a connection and agree a paper worksheet fallback in the monitoring plan, with the worksheet kept as source.
No. Capture defines visits, windows and statuses and shows what is due, but nurse booking, routing and shifts stay with the site or the nursing vendor.
Add a coded visit location field to each visit form. It exports with the rest of the data, so you can compare the two settings in analysis.
Yes. eConsent supports remote signing with an email one-time code, investigator countersignature and an exportable signed PDF with audit trail.
Sample times and tube counts go on the visit form. Where the study uses kit management, dispensing is linked to a visit and committed under e-signature, and returns are recorded as used or unused.
Yes. The free sandbox includes every feature, with no credit card and no time limit. You pay only when you go live with real participants.
Keep exploring
Build the schedule, test the checks, and rehearse a home visit in the free sandbox. No credit card; pay only when you go live.