Compliance checklistUpdated September 27, 2026

GDPR-compliant clinical trial software, checked against Capture

GDPR sets rules for how you collect, secure and limit access to personal data. It is not a badge a vendor can sell you. Capture hosts EU studies in Frankfurt, encrypts data at rest and in transit, and segregates identifiers by role, so you can check the specific controls GDPR asks for instead of taking a claim on faith.

  • EU hosting (Frankfurt)
  • PII segregated by role
  • AES-256 encryption

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

Data residency
EU

EU (Frankfurt)

Default for EU-sponsored studies

US

US (N. Virginia)

Default for US-sponsored studies

AES-256 at rest TLS/SSL in transit Chosen at study setup

2

hosting regions: EU (Frankfurt) and US (N. Virginia)

AES-256

encryption at rest, TLS/SSL in transit

3

access roles, with PII segregated from coded data

Row-level

security enforced at the database layer

The regulation

GDPR is about control over personal data, not a certificate

GDPR gives participants rights over their own data and asks you to justify why you collect it, secure it, and limit who can see it. No agency certifies software as GDPR compliant. What you can check is whether a system gives you the specific controls GDPR asks for: a lawful, secure place to store the data and limits on who can view it.

  • Choose where your study data is hosted, EU or US.
  • Limit who sees direct identifiers by role.
  • Export a participant’s data on request, filtered to just their record.
  • 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

The checklist

Six things to verify before you rely on a GDPR claim

Walk any vendor, Capture included, through this list.

Choice of EU or US hosting

Pick your data region, Frankfurt or N. Virginia, when you set up the study.

Encryption at rest and in transit

AES-256 at rest, TLS/SSL on every connection.

Role-based access to personal data

Site coordinators see names for their site, researchers see only a coded ID.

Row-level data isolation

Enforced at the database layer, not just hidden in the interface.

Control over retention

Your data, your export, not locked to one vendor’s format.

A way to export one participant’s record

CSV or Excel export, filtered to a single participant.

Access control

PII segregated from clinical data by design

A GDPR review usually asks who can see a participant’s name alongside their clinical data. Capture answers with roles: site coordinators see participant names for their own site, researchers see the same records under a coded ID, and row-level security enforces that split at the database layer, not just in what the screen shows.

  • Researcher and site coordinator roles see different fields on the same record.
  • Admin role for study configuration, separate from data entry.
  • By-site filtering, so one site never sees another site’s participants.

Site coordinator

Jane Peterson

DOB: 04-Mar-1978

Subject 01-004

Sees direct identifiers

Researcher

Subject 01-004

DOB: withheld

Coded ID only

Sees coded ID only

Same record, two roles. Row-level security enforces the split.

The difference

A shared spreadsheet vs a GDPR-aware system

Who can see a participant’s name
Anyone with the file
Only the roles you grant that permission
Where the data lives
Wherever the file was last saved
A region you choose at setup, EU or US
Encryption
Depends on the laptop and email provider
AES-256 at rest, TLS/SSL in transit, by default
Exporting one participant’s data
Manual search across files
A filtered export in a few clicks

Before you switch

The questions teams ask before they commit

Cost

EU/US hosting, encryption and role-based access are part of every plan, including the free sandbox.

Compliance

GDPR is shared: Capture provides the controls, you still document your own basis for processing.

Setup time

You pick a hosting region during study setup. No separate infrastructure to provision.

Migration

Bring an existing study in the same way, whichever system you are switching from.

Support

Email support, typically under 24 hours, plus documentation for your own assessment on Enterprise.

See EU hosting and role-based access yourself

Free sandbox with every feature. No credit card, no sales call.

See EU hosting free

FAQ

Questions teams ask before they switch

Something not covered here? Ask us directly.

Is Capture GDPR compliant?

Capture provides the specific controls GDPR asks for: EU hosting in Frankfurt, AES-256 encryption at rest, TLS/SSL in transit, and role-based access that separates personal data from coded clinical data. GDPR compliance also depends on how you configure and use the system, so pair this with your own data protection assessment.

Where is my study data hosted?

You choose at study setup: the EU region is in Frankfurt, and a US region is available in N. Virginia.

Who can see a participant’s name versus their coded ID?

Site coordinators see participant names for their own site. Researchers see the same records under a coded ID only. Row-level security enforces that split, not just the interface.

Can I export a single participant’s full record?

Yes. CSV and Excel exports can be filtered to one participant, one site, or a date range.

Does switching from another EDC carry the GDPR setup over?

Yes. Hosting region and access roles are set up the same way whichever system you are switching from. See our REDCap migration guide for a step-by-step example.

Can our data protection officer see the safeguards before we commit?

Yes. The free sandbox includes full hosting, encryption and role-based access with sample data, no credit card required.

Check the hosting and access controls yourself

Free sandbox with every feature. No credit card, no sales call.

See EU hosting free