Decentralized and hybrid trials move some or all data collection outside the clinic: eConsent instead of a paper signature at a desk, ePRO diaries instead of a site-only visit, and coordination across more than one location. This guide covers the stack a DCT actually needs and where each piece fits.
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From: Capture.Study · Sleep and Recovery Study
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Evening diary
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Week 4 questionnaire
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1
audit trail across consent, diary, CRF and safety data
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app install required for participants
3
modules in one login: EDC, eConsent, ePRO
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The DCT stack
A decentralized trial is not one tool. It is the same clinical rigor as a site-based trial, delivered through remote-friendly touchpoints.
Participants review and sign consent on their own device, with the same legal weight as an in-person signature.
QR-code enrollment with site-level or study-level codes, no app install needed.
Scheduled ePRO diaries capture symptoms and adherence between any in-person or telehealth touchpoints.
Structured CRFs capture clinician-entered data at whichever visits your protocol still requires in person.
Remote consent
Participants sign on-screen, verified through a two-step process including mandatory email confirmation, after acknowledging the legally binding statement. Investigators countersign with password re-authentication, and the document is only "Fully Executed" after that countersignature.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Between-visit data capture
ePRO diaries and questionnaires open from a link on the participant's own phone. There is no app to download and no separate login to remember between visits.
Evening diary
Question 3 of 8
How would you rate your fatigue today?
0 = no fatigue, 10 = worst imaginable
Before you switch
Free sandbox to build and test the full remote workflow; you pay only once you go live.
21 CFR Part 11-aligned controls across consent, ePRO and CRF, in one audit trail.
One platform to configure instead of separate consent, diary and EDC vendors.
Bring an existing hybrid or fully remote study across from another stack.
Email support, typically under 24 hours.
Free sandbox with every feature. No credit card, no sales call.
Capture provides the data capture side (consent, diaries, CRFs) for remote and hybrid touchpoints. Whether your protocol needs any in-person or telehealth visit is a study design decision, not a platform limitation.
No. Consent, diaries and questionnaires all open from a link on the participant's own device.
Through a two-step process including mandatory email confirmation for participants, with investigator countersignature and a legal meaning statement required before a document is "Fully Executed".
Yes. QR-code enrollment, by-site filtering and the same ePRO diaries work whether a participant is enrolled at a physical site or remotely.
This guide ties those individual features together into the full DCT stack. See the dedicated eConsent and ePRO pages for feature-level detail.
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Keep exploring
EDC for decentralized clinical trials
The core EDC fit for decentralized protocols.
eConsent for decentralized clinical trials
A closer look at the remote consent workflow.
BYOD ePRO, no app download
More on the no-install participant experience.
Remote patient monitoring for clinical trials
The broader remote monitoring pattern.
Free sandbox with every feature. No credit card, no sales call.