Use case · Multi-site studiesUpdated October 13, 2026

Multi-site clinical trial data harmonization, done at entry

Harmonizing data after the fact means months of cleaning. Capture pushes consistency to the point of entry: one locked, approved form for every site, edit checks that raise queries as values are typed, and calculated fields that never depend on local arithmetic.

  • One approved form for all sites
  • Edit checks at entry
  • By-site review and export

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

Cross-site consistency · demo study

Sites

5

Open auto-queries

11

Out-of-range values

3

Forms on approved version

100%

Site 0012/12

queries

Site 0021/12

queries

Site 0036/12

queries

Site 0042/12

queries

Demo numbers. Site 003 has a recurring unit issue worth a retraining call

What to know first

  • Data harmonization is cheapest at design and entry, and most expensive at database lock. Prevention beats cleaning.
  • In Capture every site enters data on the same approved form. Approved forms are locked for live use, so no site collects a private version.
  • Edit checks (range high, range low, custom value rules) raise an auto-query as the value is typed. Calculated fields such as BMI, eGFR and QTc are computed and read-only.
  • Multi-site tools include QR-code enrollment, site-level participant numbering (for example 001-0042), a site coordinator portal, and by-site filtering and exports.
  • Harmonization does not remove the need for training and a CRF completion guide. Software constrains entry; it does not replace judgement.

The problem

Where inconsistency across sites comes from

The same protocol, run at five sites, produces five slightly different datasets. One site records weight in kilograms and another in pounds. One writes dates as day-month, another as month-day. One treats "not done" as a blank and another as a zero. A site reads a severity scale one way, another reads it differently. Each is a small thing; together they are the reason cross-site analysis takes weeks of reconciliation.

The causes fall into four groups: format (units, date formats, decimals), definition (what counts as a baseline, an event onset or a missed visit), version (different CRF versions in use) and practice (how a measurement is actually taken). Software can attack the first and third directly, and help with the second and fourth by making the intended definition visible at the field.

This page is about the data-consistency problem. For the operational side of running many sites, see multi-site clinical trial management, and for early-phase networks EDC for multi-site early-phase trials.

Cause and control

Matching each source of inconsistency to a control

Source of inconsistencyExampleControl in Capture
Version driftSite B still uses last month's formForms move draft to approved; approved forms are locked and only approved forms appear in the casebook
Out-of-range valuesSystolic 182 typed instead of 128Range high, range low and custom value edit checks raise an auto-query at entry
Local arithmeticBMI worked out by hand with rounding differencesCalculated fields (BMI, BSA, eGFR, QTc, age from DOB) are computed and read-only
Unit ambiguityCreatinine in mg/dL at one site, umol/L at anotherUnits set on the question; lab tables carry unit, result and reference-range columns
Participant identificationDuplicate or inconsistent IDsSite-level numbering such as 001-0042 and QR-code enrollment
Hidden site driftOne site systematically differsBy-site filtering and exports make a site comparison a filter, not a project

These controls reduce variation at entry. Unit conversion between systems of measurement is a design decision; see the lab unit converter page to plan it.

At the point of entry

One form, one set of rules, every site

A form is drafted, reviewed, approved and then locked. Sites cannot add a variant. Edit checks fire as the value is entered, so a coordinator fixes a typo while the participant is still in clinic, not six weeks later.

  • Edit checks with configurable priority and your own message text.
  • Calculated fields shown read-only during entry.
  • Lab tables with analytes as rows and unit, result and reference-range columns.
  • Source data verification can be set per field, so monitors focus where it matters.
Edit checks software
Vital signs · Visit 2
Participant 003-0017 · Site 003Approved form v2

Systolic blood pressure

SYSBP
182mmHg

Above the range set for this field. Auto-query raised

Weight

WEIGHT
78.4kg

Height

HEIGHT
171cm

BMI

BMI

Calculated, read-only

26.8 kg/m2 Calculated
Demo screen with invented values

Try a five-site study in the sandbox

Create a study, add sites, enter a deliberately wrong value and see the query. Free, every feature, no credit card.

Test a multi-site study free

Running the sites

Enrollment, numbering and review across sites

Participants can enroll by QR code, specific to a site or to the whole study, with no app to install. Participant numbers are site-level, so 001-0042 tells you at a glance which site a record belongs to and prevents number collisions. Site coordinators work in their own portal, see names for their own participants, and the rest of the team works with coded IDs. See QR-code participant enrollment.

For harmonization, the reviewing side matters as much as the entry side. Data can be filtered by site and exported by site, so a data manager can compare distributions of the same variable across sites, spot the site that enters temperatures in Fahrenheit, and send a targeted note. The query management workflow then closes the loop in the record.

International studies add language, regulatory and device differences. Capture does not claim multilingual participant forms on this page; if your sites need them, confirm the current status before you design around it. The international multi-site page covers what can be planned for.

Playbook

A harmonization plan you can follow before the first site goes live

Do it once at design, and the data stay comparable for the whole study.

  1. 1

    Agree definitions

    Write down what counts as baseline, event onset, a missed visit and a not-done assessment. Put the definition into the field hint.

  2. 2

    Fix units and formats

    Choose one unit per variable and set it on the question. Decide how a missing or not-done value is recorded.

  3. 3

    Build the checks

    Add range and custom rules for the variables that matter most, and set priorities so critical queries are visible.

  4. 4

    Approve and lock

    Approve the forms and test with sample data in the sandbox. Approved forms are locked for live use.

  5. 5

    Train every site the same way

    One CRF completion guide, one training session recording, one list of common queries.

  6. 6

    Review by site monthly

    Filter by site, compare distributions and queries, and retrain where one site drifts.

FAQ

Questions teams ask before they switch

Something not covered here? Ask us directly.

How does Capture help harmonize data across sites?

Every site enters data on the same approved, locked form. Edit checks raise auto-queries at entry, calculated fields are computed and read-only, and data can be filtered and exported by site.

Can a site change the form?

No. Forms move from draft to approved and approved forms are locked for live use. Changes are deliberate amendments.

How are participants numbered?

Site-level numbering, for example 001-0042, with QR-code enrollment that is site-specific or study-specific and needs no app install.

Does Capture convert units automatically between sites?

This page does not claim automatic unit conversion. Units are set on the question, and lab tables carry unit and reference-range columns. Decide the unit policy at design time.

Can I compare sites?

Yes. Data can be filtered by site and exported by site, and site coordinators have their own portal.

Does it support multilingual forms?

This page makes no multilingual claim. Confirm current language support with us before you design a multi-country study around it.

Is it suitable for Phase 1, 2 and 3?

Yes. Capture is suitable for Phase 1, 2 and 3 multi-site studies.

How do I try it?

Open the free sandbox with every feature, no credit card and no time limit, and add sites to a test study.

Make your sites produce one dataset

Free sandbox, every feature, no credit card. Build the form once and test it across sites.

Test a multi-site study free