Data capture that monitors and sites can work in directly.
Electronic data capture is usually its own island: separate login, separate patient list, separate idea of what a site is. In MonitoHQ the eCRF sits on the same patient and visit records as monitoring, consent and IP.
- Edit checks at entry
- In-place queries
- SDV on the same screen
- Shared patient record
- 01Randomised in IWRS
- 02Consent version recorded
- 03Visit window calculated
- 04eCRF data entered
- 05Query raised and resolved
- 06SDV recorded at the visit
Six modules, one patient, no re-entry between them.
IWRS, eCRF and patient visits on the same record.
Randomisation, data capture and the visit schedule are usually three systems joined by a subject ID and a convention. Here they are three views of one patient.
One patient, not three copies
The patient randomised in IWRS is the patient whose eCRF a monitor opens. No join to maintain.
Visit windows come from the data
Randomisation sets day 0, so visit windows are derived, not kept in a parallel calendar.
SDV during the visit it belongs to
Recorded per field inside the monitoring visit the CRA is already performing.
Queries keep their context
A query sits on the field it concerns, beside the finding and the source it was checked against.
Edit checks fire at entry
Validation runs at entry, while the person who knows the answer is still looking at the source.
Enrolment numbers agree
Operational and data-capture enrolment are the same number, from the same records.
Entry, check, query and verification on one screen.
An edit check has fired and a query is open against the same field the monitor is verifying. Illustrative data.
| Field | Entered | Source | Status |
|---|---|---|---|
| Systolic BP | 128 mmHg | 128 | Verified |
| Diastolic BP | 82 mmHg | 82 | Verified |
| Heart rate | 112 bpm | 112 | Query open |
| Temperature | 37.1 °C | 37.1 | Verified |
| Weight | 74.2 kg | — | Not verified |
HR > 110 bpm at V4 — verify the reading or document an adverse event.
Please confirm the HR reading and add a comment if this was an AE.
The capture layer, without the island.
Form entry
Visit-mapped forms with field-level validation and required-field control.
Edit checks
Range, consistency and cross-form rules evaluated at entry, not in a later batch.
Queries in place
Threaded against the field, visible to the site, closed by an answer.
SDV in the visit
Verification recorded per field during the monitoring visit it belongs to.
Shared patient record
The same patient as IWRS, consent, visits and monitoring — not a linked copy.
Export
Exportable for downstream statistical work and SDTM mapping.
Common questions
How does source data verification work here?
SDV is performed against the same patient record the CRA is already working in during a monitoring visit, rather than in a separate system with its own login and its own copy of the patient list. What was verified, by whom and when is recorded on the field.
When do edit checks fire?
At entry, in the browser, while the person who knows the answer is still looking at the source. A range violation caught at entry is a question; the same violation caught in a batch run three weeks later is a query.
Who can raise and answer queries?
Monitors and data managers raise them, sites answer them, and the thread stays attached to the field in question. Query volume and ageing feed the site risk score without a separate export.
Is the data exportable in a standard format?
Data can be exported for downstream statistical work and SDTM mapping. MonitoHQ produces the operational dataset; SDTM conformance for a submission depends on your mapping and your standards work.
Connected in the same platform
Bring a form and a real edit-check rule.
30 minutes with a founder. We'll build the form, wire the check, and show what happens when a monitor queries a value in the same screen the site entered it.