WorkflowUpdated September 26, 2026

Every step of running a trial, in one workflow

From site activation to database lock, each role sees what to do next. Sites screen and enter data, monitors verify, data managers freeze and lock, and sponsors watch it all on a live dashboard.

  • Built-in gates at every step
  • Role-based work lists
  • Live oversight dashboard

Free sandbox · No credit card · 21 CFR Part 11 compliant

  • ISO 27001 certified
  • 21 CFR Part 11 compliant
  • GDPR compliant
  • EU and US data hosting
  • HIPAA compliant
  • ICH GCP E6(R3) compliant
app.capture.study · Dashboard
Capture study dashboard with enrolment, compliance, safety overview and site risk monitor

4

items on the site activation checklist

7

study roles with their own permissions

3

query states: open, answered, closed

1

dashboard across every site

The workflow

From activated site to locked data

  1. 1

    Activate sites

    Ethics approval, contract, initiation visit and delegation log, then one Activate button.

  2. 2

    Screen and enrol

    A guided screening flow assigns sequential numbers and handles rescreens.

  3. 3

    Collect and check

    Sites enter visit data, edit checks raise queries, monitors verify.

  4. 4

    Freeze and lock

    Data managers freeze and lock data field by field or in bulk.

Site activation

No participant before the site is ready

Each site passes a four-item checklist before it opens. Until it is activated, nobody can add, screen or randomize participants there, and the rule is enforced on the server, not just in the screen.

  • Ethics or IRB approval date, contract executed, site initiation visit date, delegation log complete.
  • Activation records who activated the site and when.
  • A study launches once at least one site is activated.
Site 01 · Activation
  • IRB/EC approved12-Aug-2026
  • Contract executedConfirmed
  • Site initiated / SIV completed02-Sep-2026
  • Delegation log completeConfirmed
All 4 items completeActivate site

Pre-launch readiness

1 site activated

1 form not yet approved

Screening

Screening that gets the numbers right

Adding a subject follows a short guided flow. New subjects and rescreens are handled separately, numbers are assigned in sequence, and the site confirms the details before anything is saved.

  • Screen a new subject or rescreen a previous one, linked to the old number.
  • Sequential screening numbers with your own prefix and format.
  • Informed consent date, year of birth and sex captured up front.
  • Choose which lifecycle states your study uses: pre-screened, screened, enrolled and randomized.
Add subject · Step 1 of 3

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

Next screening numberS-0014

Data quality

Queries that close themselves out

Edit checks raise queries as data is entered, and monitors raise their own. Everyone works the same list, with status, priority and age visible at a glance.

  • Open, answered and closed queries with numbers, categories and priority.
  • Answer queries in place from the casebook.
  • Export the full query list to CSV.
app.capture.study · Data queries
Capture data queries list with open, answered and closed queries, categories and priority

Walk through the whole workflow

A free sandbox comes with sample data, so you can activate a site, screen a subject and raise a query in minutes.

Run a study free

Roles

The right work for the right person

Each role sees its own tasks and permissions. Site staff enter data, monitors verify, data managers freeze and lock, and only the principal investigator signs off the casebook.

  • Study owner, principal investigator, sub-investigator and study coordinator.
  • Monitor (CRA) and data manager.
  • Participants, who complete their own questionnaires.
  • Blinded and unblinded access for randomized studies.
  • SO

    Study owner

    Builds and configures the study

  • PI

    Principal investigator

    Oversees the site, signs off the casebook

  • SI

    Sub-investigator

    Enters and signs clinical data

  • SC

    Study coordinator

    Screens subjects, enters visit data

  • CRA

    Monitor (CRA)

    Verifies data, raises queries

  • DM

    Data manager

    Reviews, freezes and locks data

  • PT

    Participant

    Completes their own questionnaires

Oversight

See every site at a glance

The study dashboard pulls enrolment, compliance, safety and site risk into one view, filtered globally, by country or by site.

  • Participant funnel from identified to randomized.
  • Safety overview with open events and serious adverse events.
  • Site risk monitor that flags sites needing attention.
  • Action items with overdue work highlighted.
Participant funnel
Identified40
Consented31
Enrolled26
Randomized22

Site risk

Site 03 needs attention

Action items

2 overdue

FAQ

Questions teams ask before they switch

Something not covered here? Ask us directly.

What is clinical trial workflow software?

It is software that supports the daily work of running a trial: activating sites, screening and enrolling participants, collecting visit data, resolving queries and locking data. Capture handles these steps in the same system where the study is built.

How does site activation work?

Each site completes a four-item checklist: ethics approval, contract, site initiation visit and delegation log. An authorized user then activates the site, which is recorded in the audit trail.

How are screening numbers assigned?

Sequentially, never randomly, using the prefix and format you set. Rescreened subjects get a new number linked to their previous one.

Which roles are supported?

Study owner, principal investigator, sub-investigator, study coordinator, monitor (CRA), data manager and participant, plus blinded and unblinded access for randomized studies.

How are queries handled?

Queries are raised automatically by edit checks or manually by monitors. They move from open to answered to closed, can be answered in place from the casebook, and can be exported to CSV.

Who can freeze and lock data?

Data managers freeze and lock data, field by field or in bulk. Unfreezing or unlocking requires a reason, and every change is in the audit trail.

Can sponsors see progress across sites?

Yes. The dashboard shows enrolment, compliance, safety and site risk, filtered globally, by country or by site.

Can I try the workflow for free?

Yes. The free sandbox includes sample data, so you can walk through each step. No credit card is needed.

Run your next study in one workflow

Free sandbox with sample data. No credit card, no sales call.

Run a study free